In this webinar, you will learn:
Trends in vaccine manufacturing
Innovative solutions in facility design
Case studies and proposals for future vaccine factories
Considerations while setting up Quality Management Systems (QMSs)
How validation helps accelerate regulatory approval
Detailed description:
How we see vaccine manufacturing evolving due to the COVID-19 pandemic, how could it further transform, and what are some solutions we can incorporate to prepare ourselves for next-generation facilities?
The unprecedented COVID-19 pandemic has driven significant tech acceleration around the world, including methods of vaccine manufacturing. Together with the concept of Bioprocessing 4.0, digital biomanufacturing enables centralized orchestration of production process and data management, and a "Facility of the Future" characterized by intensified, continuous, predictive, and autonomous operations. In this presentation, we will explore trends in vaccine manufacturing, including fully single-use processes, closed processing, modular facilities, and platform manufacturing. We will also discuss some key considerations when setting up Quality Management Systems for novel facilities, and how to speed up regulatory approval through best practices in facility validation.
Medicinal products must comply with their approved specifications before they are released into the market. Compliance with release specifications can be demonstrated by performing a complete set of tests on the active substance and/or finished product, according to the approved specifications. Under certain conditions, an alternative strategy to systematic end product testing is possible. So far this concept has been mainly applied to sterility testing of terminally sterilised products and has become associated with parametric release applications. Recent guidelines adopted in the ICH context (ICH Q8, Q9 and Q10) have made it possible to apply a similar release decision process to tests other than sterility, this approach has been called Real Time Release Testing (RTRT).
RTRT is a system of release that gives assurance that the product is of intended quality, based on the information collected during the manufacturing process, through product knowledge and on process understanding and control. RTRT recognises that under specific circumstances an appropriate combination of process controls (critical process parameters) together with pre-defined material attributes may provide greater assurance of product quality than end-product testing and the context as such be an integral part of the control strategy. The RTRT principle is already authorised for use as an optional alternative to routine sterility testing of products terminally sterilised in their final container i.e. parametric release. Enhanced product knowledge and process understanding, the use of quality risk management principles and the application of an appropriate pharmaceutical quality system, as defined within ICH Q8,Q9 and Q10 provide the platform for establishing RTRT mechanisms for other applications, for new products as well as established marketed products. Release of a product can be a combination of a RTR approach for certain critical quality attributes (CQAs) and a more conventional evaluation for other CQAs (partial RTR).
This presentation deals with the concepts of Real Time Release Testing. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Sy...Merck Life Sciences
The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.
In this webinar, you will learn:
● An approach to adopt the BioPhorum Operations Group (BPOG) extractables protocol as a baseline testing strategy.
● How to apply extractables data to a specific process followed by a systematic, risk-based safety assessment approach used for comparing known safety concern thresholds.
● The important stages in the risk assessment process as demonstrated by case studies from typical drug manufacturing processes where single-use components were used.
Extractables profiles for chromatography resins - adapted approach of upcomin...Merck Life Sciences
Watch the webinar here: https://bit.ly/36JaZpx
In biopharmaceutical industry there is a trend towards comprehensive risk assessments of drug manufacturing processes. Extractables studies for chromatography resins based on the adapted requirements of the upcoming USP <665> support risk evaluation for your specific chromatography steps.
In this webinar, you will learn about:
- Study design for extractables profiles of chromatography resins
- The new category Emprove® Chromatography
- Communication of extractables data as part of Emprove® Dossiers
Description:
Detailed information on any component or material in contact with the drug substance/ product is required to conduct a compreshensive risk assessment of a biopharmaceutical manufacturing process. No explicit guidelines providing required testing procedures for chromatography steps are in place yet. In the upcoming USP <665> chapter chromatography steps are in focus as well as any other plastic or polymeric component and can as such assessed as to the described criteria. To support our chromatography resin users an adapted extractables study approach was developed. The webinar will demonstrate our study design and the communication of the extractables profiles within our Emprove® Program.
Presentation on ICH guidelines Q5A (R1) and Q4B Annex 2 (R1)HadiaNaz1
EXECUTIVE SUMMARY OF ICH GUIDELINES Q5A (R1) AND Q4B ANNEX 2 (R1)
VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN – Q4B ANNEX 2 (R1):
This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin. The scope of the document covers products derived from cell cultures initiated from characterized cell banks. It covers products derived from in vitro cell cultures, recombinant DNA – derived products and also includes products derived from hybridoma cells grown in vivo.
Three principal approaches have evolved to control the potential viral contamination of biotechnology products:
a) Selecting & testing cell lines and other raw materials, including media components, for the absence of undesirable viruses which may be infectious and/or pathogenic for humans.
b) Assessing the capacity of the production processes to clear infectious viruses.
c) Testing the product at appropriate steps of production for absence of contaminating infectious viruses.
The guideline suggests approaches for the evaluation of the risk of viral contamination and for the removal of virus from the product. Following are the recommended tests for the brief description of a general framework and philosophical background within which the manufacturer should justify the testing that was done;
1) Test for Retroviruses
2) In vitro Assay
3) In vivo Assay
4) Antibody Production Tests
TEST FOR EXTRACTABLE VOLUME OF PARENTRAL PREPARATIONS GENERAL CHAPTER – Q4B ANNEX 2 (R1):
This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). The acceptance criteria of this document are same in the three pharmacopoeias.
The annex contains the following considerations for the implementation;
1) General Consideration
2) FDA Consideration
3) EU Consideration
4) MHLW Consideration
This talk will provide an overview of the PaaS (Platform as a Service) landscape, and will describe the Cloud Foundry open source PaaS, with its multi-framework, multi-service, multi-cloud model.
Cloud Foundry allows developers to provision apps in Java/Spring, Ruby/Rails, Ruby/Sinatra, Javascript/Node, and leverage services like MySQL, MongoDB, Reddis, Postgres and RabbitMQ. It can be used as a public PaaS on CloudFoundry.com and other service providers (ActiveState, AppFog), to create your own private cloud, or on your laptop using the Micro Cloud Foundry VM.
The talk will end with a demo of Cloud Foundry in action, showing the end to end development workflow, from developing locally with Micro Cloud Foundry to deploying on Cloud Foundry.com.
If you want to get started with Cloud development, bring your laptops, check the requirements and download pre-requisites at https://cloudfoundry.com/micro, and we'll help you setup your environment and get started with Cloud Foundry on your local machine.
Medicinal products must comply with their approved specifications before they are released into the market. Compliance with release specifications can be demonstrated by performing a complete set of tests on the active substance and/or finished product, according to the approved specifications. Under certain conditions, an alternative strategy to systematic end product testing is possible. So far this concept has been mainly applied to sterility testing of terminally sterilised products and has become associated with parametric release applications. Recent guidelines adopted in the ICH context (ICH Q8, Q9 and Q10) have made it possible to apply a similar release decision process to tests other than sterility, this approach has been called Real Time Release Testing (RTRT).
RTRT is a system of release that gives assurance that the product is of intended quality, based on the information collected during the manufacturing process, through product knowledge and on process understanding and control. RTRT recognises that under specific circumstances an appropriate combination of process controls (critical process parameters) together with pre-defined material attributes may provide greater assurance of product quality than end-product testing and the context as such be an integral part of the control strategy. The RTRT principle is already authorised for use as an optional alternative to routine sterility testing of products terminally sterilised in their final container i.e. parametric release. Enhanced product knowledge and process understanding, the use of quality risk management principles and the application of an appropriate pharmaceutical quality system, as defined within ICH Q8,Q9 and Q10 provide the platform for establishing RTRT mechanisms for other applications, for new products as well as established marketed products. Release of a product can be a combination of a RTR approach for certain critical quality attributes (CQAs) and a more conventional evaluation for other CQAs (partial RTR).
This presentation deals with the concepts of Real Time Release Testing. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Sy...Merck Life Sciences
The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.
In this webinar, you will learn:
● An approach to adopt the BioPhorum Operations Group (BPOG) extractables protocol as a baseline testing strategy.
● How to apply extractables data to a specific process followed by a systematic, risk-based safety assessment approach used for comparing known safety concern thresholds.
● The important stages in the risk assessment process as demonstrated by case studies from typical drug manufacturing processes where single-use components were used.
Extractables profiles for chromatography resins - adapted approach of upcomin...Merck Life Sciences
Watch the webinar here: https://bit.ly/36JaZpx
In biopharmaceutical industry there is a trend towards comprehensive risk assessments of drug manufacturing processes. Extractables studies for chromatography resins based on the adapted requirements of the upcoming USP <665> support risk evaluation for your specific chromatography steps.
In this webinar, you will learn about:
- Study design for extractables profiles of chromatography resins
- The new category Emprove® Chromatography
- Communication of extractables data as part of Emprove® Dossiers
Description:
Detailed information on any component or material in contact with the drug substance/ product is required to conduct a compreshensive risk assessment of a biopharmaceutical manufacturing process. No explicit guidelines providing required testing procedures for chromatography steps are in place yet. In the upcoming USP <665> chapter chromatography steps are in focus as well as any other plastic or polymeric component and can as such assessed as to the described criteria. To support our chromatography resin users an adapted extractables study approach was developed. The webinar will demonstrate our study design and the communication of the extractables profiles within our Emprove® Program.
Presentation on ICH guidelines Q5A (R1) and Q4B Annex 2 (R1)HadiaNaz1
EXECUTIVE SUMMARY OF ICH GUIDELINES Q5A (R1) AND Q4B ANNEX 2 (R1)
VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN – Q4B ANNEX 2 (R1):
This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin. The scope of the document covers products derived from cell cultures initiated from characterized cell banks. It covers products derived from in vitro cell cultures, recombinant DNA – derived products and also includes products derived from hybridoma cells grown in vivo.
Three principal approaches have evolved to control the potential viral contamination of biotechnology products:
a) Selecting & testing cell lines and other raw materials, including media components, for the absence of undesirable viruses which may be infectious and/or pathogenic for humans.
b) Assessing the capacity of the production processes to clear infectious viruses.
c) Testing the product at appropriate steps of production for absence of contaminating infectious viruses.
The guideline suggests approaches for the evaluation of the risk of viral contamination and for the removal of virus from the product. Following are the recommended tests for the brief description of a general framework and philosophical background within which the manufacturer should justify the testing that was done;
1) Test for Retroviruses
2) In vitro Assay
3) In vivo Assay
4) Antibody Production Tests
TEST FOR EXTRACTABLE VOLUME OF PARENTRAL PREPARATIONS GENERAL CHAPTER – Q4B ANNEX 2 (R1):
This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). The acceptance criteria of this document are same in the three pharmacopoeias.
The annex contains the following considerations for the implementation;
1) General Consideration
2) FDA Consideration
3) EU Consideration
4) MHLW Consideration
This talk will provide an overview of the PaaS (Platform as a Service) landscape, and will describe the Cloud Foundry open source PaaS, with its multi-framework, multi-service, multi-cloud model.
Cloud Foundry allows developers to provision apps in Java/Spring, Ruby/Rails, Ruby/Sinatra, Javascript/Node, and leverage services like MySQL, MongoDB, Reddis, Postgres and RabbitMQ. It can be used as a public PaaS on CloudFoundry.com and other service providers (ActiveState, AppFog), to create your own private cloud, or on your laptop using the Micro Cloud Foundry VM.
The talk will end with a demo of Cloud Foundry in action, showing the end to end development workflow, from developing locally with Micro Cloud Foundry to deploying on Cloud Foundry.com.
If you want to get started with Cloud development, bring your laptops, check the requirements and download pre-requisites at https://cloudfoundry.com/micro, and we'll help you setup your environment and get started with Cloud Foundry on your local machine.
Process development considerations for quality and safety of vaccinesDr. Priyabrata Pattnaik
"New Technologies Symposium" presentation at Annual General Meeting of Developing Country Vaccine Manufacturers Network (DCVMN), 5th-7th October 2015, Bangkok, Thailand.
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell...Merck Life Sciences
Participate in the interactive webinar: http://bit.ly/CHOZNWebinar
In this case study, we will present how we support our clients thanks to advantages provided by the CHOZN® Cell Line, and a specific strategy for clone selection where semi-automation and pool selection are leveraged, to get upstream right first time.
Explore our webinar library: www.merckmillipore.com/webinars
Streamlining Biopharmaceutical Cell Line Development - Reducing risk and decr...Merck Life Sciences
CHO cells with their unique characteristics, represent the major expression system within the biopharmaceutical industry. However, one of the major challenges in cell line development is to identify those rare, high-producing clones in a huge population of non-expressing or low-expressing cell lines. This leads to laborious and time consuming cell line development processes. This webinar will educate the audience about challenges faced with traditional expression systems and how the CHO cell line with the glutamine synthethase knock-out via Zinc Finger Nucleases provides benefits for fast and efficient cell line development as well as stable and high titer expression. We will explore additional cell line engineering targets that can be modified to engineer a cell line that mitigates risks and removes bottlenecks throughout the biopharmaceutical process.
In this webinar, you will learn:
• What are the benefits of using an optimized/engineered expression system?
• What can be done throughout the cell line development process to mitigate risks and remove bottlenecks?
• Applications of cell line engineering for further upstream biopharmaceutical enhancements.
this presentation is about the control and measurements of pH and red-ox potential in a fermenter or a bioreactor. there are several parameters that should be monitored in order to get the maximum productivity in a fermenter. in that few parameters are very much important to measure as well adjust to its optimum level to get the high yield.
The topic is about beer production. How beer is produced that is highlited here.some good pictures are also presented here.How much ammount of the alcoholos are present that is also mentioned here.
The three hybrid system of yeast has been described in this ppt. Yeast one Hybrid system, yeast two hybrid system and yeast 3 hybrid system is explained. This explain about the DNA-protein interaction and Protein-DNA-Protein interaction.
Understanding How Bioburden and Sterilization Affect Medical DevicesPacific BioLabs
This presentation covers:
Bioburden- what is it and how it can affect a device development program and sterilization validation program.
Sterilization: methods and the bioburden-sterilization connection.
Benefits of minimizing the sterilization dose for your device.
Importance of monitoring bioburden.
Case study: sterilization failure and tracking down root cause.
How to monitor and reduce bioburden levels.
Fermentation technology, Bioprocess Principles, History of Industrial Biotechnology, Bioreactor Principles, Bioreactor Design, Parameters to be monitored in Bioreactor, Fermentation Technology, Agitation and Mixing, Baffles
Webinar: Re-imagining vaccine manufacturing to address global health challengesMerck Life Sciences
Participate in the interactive on demand webinar: http://bit.ly/ReimaginingVaccinesWebinar
In this webinar, you will learn:
- The evolution of vaccine production in response to pandemics and outbreaks
- Key considerations and perspectives on how vaccine processing and facilities could change to address future global health challenges
Webinar: Re-imagining vaccine manufacturing to address global health challengesMilliporeSigma
Participate in the interactive on demand webinar: http://bit.ly/ReimaginingVaccinesWebinar
In this webinar, you will learn:
- The evolution of vaccine production in response to pandemics and outbreaks
- Key considerations and perspectives on how vaccine processing and facilities could change to address future global health challenges
Process development considerations for quality and safety of vaccinesDr. Priyabrata Pattnaik
"New Technologies Symposium" presentation at Annual General Meeting of Developing Country Vaccine Manufacturers Network (DCVMN), 5th-7th October 2015, Bangkok, Thailand.
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell...Merck Life Sciences
Participate in the interactive webinar: http://bit.ly/CHOZNWebinar
In this case study, we will present how we support our clients thanks to advantages provided by the CHOZN® Cell Line, and a specific strategy for clone selection where semi-automation and pool selection are leveraged, to get upstream right first time.
Explore our webinar library: www.merckmillipore.com/webinars
Streamlining Biopharmaceutical Cell Line Development - Reducing risk and decr...Merck Life Sciences
CHO cells with their unique characteristics, represent the major expression system within the biopharmaceutical industry. However, one of the major challenges in cell line development is to identify those rare, high-producing clones in a huge population of non-expressing or low-expressing cell lines. This leads to laborious and time consuming cell line development processes. This webinar will educate the audience about challenges faced with traditional expression systems and how the CHO cell line with the glutamine synthethase knock-out via Zinc Finger Nucleases provides benefits for fast and efficient cell line development as well as stable and high titer expression. We will explore additional cell line engineering targets that can be modified to engineer a cell line that mitigates risks and removes bottlenecks throughout the biopharmaceutical process.
In this webinar, you will learn:
• What are the benefits of using an optimized/engineered expression system?
• What can be done throughout the cell line development process to mitigate risks and remove bottlenecks?
• Applications of cell line engineering for further upstream biopharmaceutical enhancements.
this presentation is about the control and measurements of pH and red-ox potential in a fermenter or a bioreactor. there are several parameters that should be monitored in order to get the maximum productivity in a fermenter. in that few parameters are very much important to measure as well adjust to its optimum level to get the high yield.
The topic is about beer production. How beer is produced that is highlited here.some good pictures are also presented here.How much ammount of the alcoholos are present that is also mentioned here.
The three hybrid system of yeast has been described in this ppt. Yeast one Hybrid system, yeast two hybrid system and yeast 3 hybrid system is explained. This explain about the DNA-protein interaction and Protein-DNA-Protein interaction.
Understanding How Bioburden and Sterilization Affect Medical DevicesPacific BioLabs
This presentation covers:
Bioburden- what is it and how it can affect a device development program and sterilization validation program.
Sterilization: methods and the bioburden-sterilization connection.
Benefits of minimizing the sterilization dose for your device.
Importance of monitoring bioburden.
Case study: sterilization failure and tracking down root cause.
How to monitor and reduce bioburden levels.
Fermentation technology, Bioprocess Principles, History of Industrial Biotechnology, Bioreactor Principles, Bioreactor Design, Parameters to be monitored in Bioreactor, Fermentation Technology, Agitation and Mixing, Baffles
Webinar: Re-imagining vaccine manufacturing to address global health challengesMerck Life Sciences
Participate in the interactive on demand webinar: http://bit.ly/ReimaginingVaccinesWebinar
In this webinar, you will learn:
- The evolution of vaccine production in response to pandemics and outbreaks
- Key considerations and perspectives on how vaccine processing and facilities could change to address future global health challenges
Webinar: Re-imagining vaccine manufacturing to address global health challengesMilliporeSigma
Participate in the interactive on demand webinar: http://bit.ly/ReimaginingVaccinesWebinar
In this webinar, you will learn:
- The evolution of vaccine production in response to pandemics and outbreaks
- Key considerations and perspectives on how vaccine processing and facilities could change to address future global health challenges
Insights from a Global Collaboration Accelerating Vaccine Development with an...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug
Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process.
The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine.
In this webinar, you will learn:
• About building a priceless collaborative network with integrated solutions
• Virus-Like Particle Vaccines
• Process Development Overview and Challenges
• Pre-clinical Results and Next Steps
Presented by:
Jose M. Galarza, PhD,
President and Founder of TechnoVax
Naomi Baer,
Business development consultant, Emerging Biotech, BioProcess division
Youssef Gaabouri, Eng. ,
Associate Director, Head of Sales Middle East & Africa, BioProcess division
Insights from a Global Collaboration Accelerating Vaccine Development with an...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug
Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process.
The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine.
In this webinar, you will learn:
• About building a priceless collaborative network with integrated solutions
• Virus-Like Particle Vaccines
• Process Development Overview and Challenges
• Pre-clinical Results and Next Steps
Presented by:
Jose M. Galarza, PhD,
President and Founder of TechnoVax
Naomi Baer,
Business development consultant, Emerging Biotech, BioProcess division
Youssef Gaabouri, Eng. ,
Associate Director, Head of Sales Middle East & Africa, BioProcess division
Developing a single use adenovirus-vectored vaccine process through public-pr...MilliporeSigma
This work highlights the importance of collaborations to accelerate vaccine process development and manufacturing under the constant pressure of emerging diseases and the growing need of global immunizations.
We are collaborating with the Jenner Institute of the University of Oxford to advance the development of a rapid, scalable and GMP compliant process for simian adenoviruses used as vector for vaccines such as Rabies and emerging threats like Zika and Ebola. This webinar will describe the transition from a labor and time intensive process development to one utilizing a maximum of disposable technologies such as single use bioreactors and filtration technologies, using the rabies vaccine as a first candidate. We will highlight the challenges and their corresponding solutions that in the end created a template that can be used for different types of adenoviral vectors-based vaccines manufacturing.
In this webinar, you will learn:
- The challenges of creating a rapid and scalable process for Adenovirus vector manufacturing.
- The solutions that overcame those challenges.
- How public-private collaborations can accelerate vaccine process development.
Developing a single use adenovirus-vectored vaccine process through public-pr...Merck Life Sciences
This work highlights the importance of collaborations to accelerate vaccine process development and manufacturing under the constant pressure of emerging diseases and the growing need of global immunizations.
We are collaborating with the Jenner Institute of the University of Oxford to advance the development of a rapid, scalable and GMP compliant process for simian adenoviruses used as vector for vaccines such as Rabies and emerging threats like Zika and Ebola. This webinar will describe the transition from a labor and time intensive process development to one utilizing a maximum of disposable technologies such as single use bioreactors and filtration technologies, using the rabies vaccine as a first candidate. We will highlight the challenges and their corresponding solutions that in the end created a template that can be used for different types of adenoviral vectors-based vaccines manufacturing.
In this webinar, you will learn:
- The challenges of creating a rapid and scalable process for Adenovirus vector manufacturing.
- The solutions that overcame those challenges.
- How public-private collaborations can accelerate vaccine process development.
The conference will provide an interactive networking forum to both further develop and answer your queries through a vibrant exhibition room full of technology providers showcasing their technologies and other solutions, poster presentation sessions, expert led case study presentations, a high-level panel discussion, a round table discussion session, and interactive Q&A sessions from a 40-strong speaker faculty examining topics on 4 separate tracks outlined below.
Vaccine development is just the first step in eradicating the pandemic, the real challenge lies in managing and handling its supply chain. An ERP built specifically for Vaccines can be the way out in efficiently fighting these challenges. Go through the presentation to know how exactly an ERP for vaccines helps.
The diagnosis of viral pathogens is a crucial component of plant biosecurity surveillance and preventing the introduction of exotic plant viruses and viroids at the border. Existing quarantine procedures can be time-consuming and require detailed knowledge of potential infecting viral pathogens. Currently, imported plants can spend as long as two years in quarantine, with associated costs.
To simplify the post-entry quarantine process researchers have developed a plant diagnostic toolkit for plant viruses and viroids. The toolkit takes advantage of the natural antiviral system of plants, using small RNA next generation sequencing (sRNA-seq) technology to detect nearly all known viruses and viroids in a single test. The new test, and associated toolkit, will reduce the time imported plant material spends in Australia’s quarantine system while improving accuracy of detection in a single sRNA-seq experiment.
Accelerate innovation and manufacturing in cell and gene therapy.pptxGenScript ProBio
The rapid expansion of the gene and cell therapy pipeline created constraints to accessing contract capacities around the globe. Innovation in gene and cell therapy expanded many drug development pipelines, and startups that are lacking internal production capacities heavily rely on contract manufacturing organizations (CDMO).
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3jmLYHu
State-of-the-art vaccine technologies are transforming vaccine development, and solutions for fast and reliable production are needed.
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platform.
In this webinar, you will learn:
• Benefits of platform technologies in vaccine development
• Key considerations when deciding between platforms
• Vaccine pipeline analysis and selected case studies
Presented by:
David Loong, Ph.D, Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Josephine Cheng, Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3jmLYHu
State-of-the-art vaccine technologies are transforming vaccine development, and solutions for fast and reliable production are needed.
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platform.
In this webinar, you will learn:
• Benefits of platform technologies in vaccine development
• Key considerations when deciding between platforms
• Vaccine pipeline analysis and selected case studies
Presented by:
David Loong, Ph.D, Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Josephine Cheng, Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy
The 10 most trusted vaccine solution providers, 2020Merry D'souza
In this edition, ‘The 10 Most Trusted Vaccine Solution Providers, 2020’ CIO Look has shortlisted various healthcare organizations which are playing an important role towards the global healthcare system.
Similar to Ways Forward – Vaccine Manufacturing Tomorrow (20)
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...MilliporeSigma
Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process.
This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work.
Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Use of Excipients in Downstream Processing to Improve Protein PurificationMilliporeSigma
Excipients are used to improve the stability of protein-based therapeutics by protecting the protein against a range of stress conditions such as temperature changes, pH changes, or agitation. Similar stresses are applied to proteins during downstream purification. Shifts in pH during Protein A chromatography, subsequent incubations at low pH for virus inactivation, and changes in conductivity in ion exchange chromatography can lead to aggregation, fragmentation, or other chemical modifications of the therapeutic protein. Given the potential impact on the protein’s structural integrity, there is a need for approaches to reduce the risk presented by the conditions during downstream processing. For example, integration of a solution to prevent aggregation of proteins would be a more efficient strategy than implementing steps to remove multimeric forms.
This white paper highlights the results from a recent paper by Stange et. al., in which protein stabilizing excipients such as polyols, sugars, and polyethylene glycol (PEG4000) were used as buffer system additives. Effect of the excipients on elution patterns, stabilization of the monomer antibody, host-cell protein removal, virus inactivation rates and binding capacity of cation exchange chromatography were explored.
Exploring the protein stabilizing capability of surfactants against agitation...MilliporeSigma
Agitation of therapeutic protein solutions during manufacturing, shipping and handling is one of the major initiators for protein aggregation and particle formation during the life history of a protein drug. Adsorption of protein molecules to liquid-air interfaces leads to the formation of highly concentrated protein surface films. The rupture of these protein films due to various mechanical processes can then result in the appearance of protein aggregates and particles in the bulk solution phase.
One technique to stabilize proteins against stress induced by liquid-air interfaces is the use of non-ionic surfactants. About 91% of antibody formulations commercially available in 2021 contained a surfactant. Polysorbate 20 and 80, composed of a hydrophilic polyoxyethylene sorbitan and hydrophobic fatty acid esters, made up the largest part being employed in 87% of said formulations.
Despite their frequent use in parenteral drug products, concerns have been raised for decades about the application of polysorbates as surfactants in biopharmaceutical formulations. Autoxidation of polysorbate, caused by residual peroxides in polysorbates, can damage the proteins and can further drive the oxidative degradation of polysorbate. Chemical and enzymatic hydrolysis of polysorbate may lead to the formation of free fatty acid particles, which may become visible; and both mechanisms eventually lead to the reduction in polysorbate concentration. Therefore, the purpose of the current study was to compare various molecules for their capabilities to reduced agitation-induced protein aggregation and particle formation; and furthermore, investigate their underlying protein stabilizing mechanisms.
The Viscosity Reduction Platform: Viscosity Reducing Excipients for Protein F...MilliporeSigma
Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection.
This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity.
To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Characterization of monoclonal antibodies and Antibody drug conjugates by Sur...MilliporeSigma
Watch the presentation of this webinar: https://bit.ly/3Pjpjvr
Highlights of this webinar:
- Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs.
- SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations.
- Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies.
- The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process
Detailed description:
Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life.
An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.
Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs.
The Role of BioPhorum Extractables Data in the Effective Adoption of Single-U...MilliporeSigma
Regulatory expectation does require patient safety evaluations with supporting data for manufacturing components that directly come into contact with drug manufacturing process streams. Readily available extractables data can help manufacturers using singleuse technology to accelerate product qualifications, risk assessments and process optimization
This white paper guides you on how to save time and resources with supplier-provided single-use system extractables data and gives you an overview about the overall strategy for Extractables & Leachables. At the end you will find a case study.
Find more information about filters and single-use components on our website: https://www.sigmaaldrich.com/DE/en/services/product-services/emprove-program/emprove-filter-and-single-use-component-portfolio
The Future of Pharma- and Biopharmaceutical AuditsMilliporeSigma
Watch the recording of this presentation here: https://bit.ly/3zTOpe4
Detailed description:
SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits.
In this webinar, you will learn:
• Regulatory overview of remote audits
• The technologies needed to support the audit process
• What types of inspections are possible with the use of these technologies
• How audits may look in the future
Presented by:
Daniel Buescher, Product Manager - Digital Solutions
Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Land...MilliporeSigma
Watch the recording of this presentation here: https://bit.ly/3SqOsoP
Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years.
Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance.
In this webinar, we'll answer:
• Which regulatory guidelines do you need to comply for your INDs?
• When do you start implementing GMPs and validated assays?
• How do you get your QC testing strategy ‘right the first time’?
• How do you ensure testing is not your rate limiting step for the IND submission?
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions
Identity testing by NGS as a means of risk mitigation for viral gene therapiesMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3RijkHC
Detailed description:
Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented.
The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources.
Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches.
In this webinar, we'll explore:
• Regulatory requirements for identity testing
• NGS applications for identity testing as compared to traditional methods
• A case study on the impact of not establishing a proper risk-based testing strategy
Presented by: Bradley Hasson, Director of Lab Operations for NGS Services
Latest advancements of melt based 3D printing technologies for oral drug deli...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3A2WcH4
The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing.
Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented:
The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures.
In this webinar, you will learn:
• Latest advancements of melt based 3D printing approaches
• Application examples for the individual technologies
• Deep dive in the MED® 3D printing technology to design dedicated drug release profiles
Presented by:
Dr. Thomas Kipping, Head of Drug Carriers
Dr. Xianghao Zuo, Deputy Director of R&D, Triastek
CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes a...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3NDNIKe
Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed.
This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection.
In this webinar, you will:
• Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps
• Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal
• Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps
Presented by:
Benjamin Ross-Johnsrud, Acoustic Technology Expert
Robert Scott, Mechanical Engineer III
How does the ICH Q5A revision impact viral safety strategies for biologics?MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg
How does the ICH Q5A revision impact viral safety strategies for biologics?
Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn about:
• The Importance of virus testing in biologics products
• Regulatory landscape, expectations for the Q5A revision
• What's new and changing
• Examples of alternate testing schedules, impact on viral clearance
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3adaxWh
When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs.
They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost?
In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement).
To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle.
Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance.
In this webinar, let's explore:
• Challenges of automation and digital technology adoption
• What a product, process, and system agnostic platform entails
• Applications and benefits of a process orchestration platform
• Ensuring future readiness with process orchestration
Presented by:
Braj Nandan Thakur, Global Product Manager - Automation
Risk-Based Qualification of X-Ray Sterilization for Single-Use SystemsMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3vQf0qv
In the single-use bioprocess industry, X-ray irradiation warrants consideration as an alternate sterilization technology. Using a risk-based qualification testing strategy is important when evaluating and implementing equivalent ionizing irradiation sterilization methods.
The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods.
In this webinar, you will learn about:
• The comparison of gamma and X-ray irradiation sterilization
• A risk-based qualification test strategy
• Data evaluation of gamma versus X-ray sterilized single-use components
Presented by:
Monica Cardona,
Global Senior Program Manager
Paul Killian, Ph.D.,
R&D Director, Analytical Technologies
Rapid Replication Competent Adenovirus (rRCA) Detection: Accelerate your Lot ...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V
Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release.
Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines.
In this webinar, you will learn about:
• Regulatory framework for adenoviral vector products
• Considerations for lot release testing of adenoviral-based therapies
• Advantages of a rapid method for RCA testing on production lot material
Presented by:
Axel Fun, Ph.D.,
Principal Scientist
Alberto Santana, MBA,
Product Manager, Biologics Biosafety Testing
The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patien...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3vQyN7K
Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations.
Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects:
• excellent sugar-like taste profile
• outstanding sweetness factors
• use effectiveness
• enhanced stability
We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception.
In this webinar, you will learn:
• How to optimize the patients' taste experience of your pharmaceuticals
• How sweeteners can be differentiated by their sensory profiles and features
• How our new product offering Neotame can be effectively used in your targeted formulations
Presented by:
Almut von der Brelie,
Senior Manager Strategic Marketing, Excipients for Solid Applications
The Developability Classification System (DCS): Enabling an Optimized Approac...MilliporeSigma
This whitepaper by Dr. Daniel Joseph Price outlines how poorly soluble drug formulations can be designed using the developability classification system (DCS).
The DCS identifies the root cause of low solubility and enables lean, cost-effective and effective formulations to be developed.
#solubility #pharmaceuticalmanufacturing #oralsoliddosage #drugdevelopment
How to Accelerate and Enhance ADC TherapiesMilliporeSigma
In this webinar, you will learn about:
The advantages of using advanced intermediates to develop ADC therapies
How to increase ADC solubility and efficiency
Fast, small-scale ADC library generation
Seamless supply chain with reduced complexity and regulatory support
The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window.
Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster.
EU GMP Annex 1 Draft - Closed System Design Consideration with Single-Use Sys...MilliporeSigma
Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. Please attend the webinar to learn more!
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
2. 2
The Life Science business of
Merck KGaA, Darmstadt, Germany
operates as MilliporeSigma
in the U.S. and Canada.
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
4. Introduction Vaccine today
Though COVID-19 has remarkable records, there are remaining
actions needed to strengthen the vaccine ecosystem
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
4
Int’ Organizations
WHO/GAVI
Manufacturers
Caregivers
Govt.
Regulatory
Agencies
Foundations
1st EAU in
362 Days
11B COVID-
Doses (2021)
vs 5.5B (2019)
1st COVAX
shipment
in 80 days
after HIC
Sustainable
Immunization
programs
Reduce
morbidity/
mortality
No. of
vaccines
indications
Global
Pandemic
Preparedness
Global
Equitable
Access
Ensure supply
meets
demand
Skilled
workforce
New models
increases mfg.
capacity
Digital
Technologies
/ innovations
Trust &
confidence in
community
Maintain
Prioritization/
Investment
Ecosystem
Source:Vaccine Ecosystem consensus statement, The Economists, May 2021
High Quality
Standards
6. Evolution of vaccine processing
Industry 4.0
Agile vaccine
manufacturing
COVID pandemic
acceleration
The current COVID pandemic and the Industry 4.0 acceleration
have dramatically highlighted the desire and need to have
concrete solutions for agile vaccine manufacturing
New way of
working
6 Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
7. Vaccine Factory Transformation
1
• Large floor space and
cleanrooms
• Complex piping
• Extensive preparation
7
1990S Legacy
Now : New facility
generation
3
4
Factory of the
future
Lonza Cocoon® Platform
Univercells NevoLine™ Platform
iCONTM ready PODS
Reduce floor plant for non
productive activities
Smaller clean rooms
Simple infrastructure
Supply on demand
Open rooms
Lower room classification
Multiproduct
Closed & smaller processes
Ultra compact & Full
equipment orchestration
Modular & Flexible (easy
scale-up)
Fully integrated (process/QC)
Fully closed
2
2010S Pre
designed facilities
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
8. Scalability
Need to be able to produce huge amount of
doses in a short time
Global vaccine manufacturing capacity may
not be sufficient for COVID19
Time
The typical vaccine paradigm doesn’t allow
adequate response to tackle outbreaks
Cost
Vaccine development & licensure requires
>$500 million
No guaranteed long-term market
Major Challenges in Vaccine manufacturing with Outbreak & Pandemic
A Paradigm Shift with Pandemics
8
Time Compression
From 10+ to 1-3 years (From
PD to Commercialization)
Platform technology
Focus on mRNA, Viral Vectors,
VLP etc.
Technology
innovation
Single-Use (Final Fill, full SU
platforms etc.), Yield
improvements…
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
9. What makes “factory of the future” difficult to design for Vaccines?
9
DNA
vaccine
Traditional vaccine
Conjugated
vaccine
Viral vector
vaccine
Virus-like
particles
Modern to cutting edge vaccine
Live
attenuated
virus
Inactivated
virus
RNA
vaccine
« One bug – one drug » « One platform – multiple vaccines»
Toxoid
Whole
bacteria
Recombinant
protein
Biosafety
• Fully closed processing to protect
✓ Operators
✓ the product when sterile filtration is not possible (Live
Virus Vaccine)
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
10. 10
Virus
Fragmentation
Media &
Inoculation
preparation
Fermentation &
virus Infection
Clarification
Virus
inactivation
Filtration
Concentration
Centrifugation
Nucleic acid
removal
Clarification
Virus inactivation Concentration Sterile filtration
Final Fill
Fertilized Eggs
& Virus Infection
Clarification Virus
inactivation Pre-
Filtration
Concentration
Centrifugation
Virus
Fragmentation
Clarification
Virus inactivation
Concentration
Sterile filtration Final Fill
Flu Vaccine process comparison
Cell based
Egg based
VS
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
12. - Multiple modalities
- Multiple Biologic agents
- Biosafety : Cross
contamination
- Products & operators
protection
- Could require full process
sterility
- Conservative mindset
(Historical treatment)
Evolutive factory for vaccine : easiness for implementation
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
12
Implementation
Vaccine
Mab
- One modality
- Easier Biosafety
management
- Product protection
- Innovative mindset
Vaccine vs
Mab
comparison
13. Making flexible factories for vaccine is possible today!
13
• Process simplification : One process for one disease vs Manufacturing Platforms
• Smaller equipment footprint => smaller facilities
• New facility type & new ways of working : Automation, Modular, BallRoom, digital twin
• Single-use products
Development of new technologies as Digitalization, equipment modernization and
progress in bioscience allow the transformation of vaccine biomanufacturing :
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
Advantages of Single-use technologies
- Reduce Capital
- Reduces cross contamination risk (closed processing)
- Ease to use (plug and play)
- Reducing cleaning costs
- Faster production
- Flexibility to scale or process
14. Making flexible factories for vaccine is possible today!
14
• Process yield improvements : Continuous processing / Process Intensification etc.
• More collaborations between big manufacturing players and universities, small biotechs etc.
(ie. AZ with Oxford University, Pfizer & BioNtech etc.)
• Carbon footprint care / Focus
CO2
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
Example of recombinant process
16. Templates vs Traditional vaccines
Supports
bioprocessing
standardization
1
Reduce process
development
time and cost
2
3
4
Reduce
significant
manufacturing
changes
Ease of
regulatory
approval
16 Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
17. Process comparison between classical template vs Platform
17
mRNA Platform
In vitro
Transcription
Chromatography UF/DF
Linear DNA mRNA
pDNA
Purify
Make
mRNA
LNP drug
product
Encapsulation Sterile Filtration &
Fill and Finish
mRNA
UF/DF &
Final formulation
Formulate
1 2
3
VS
Inactivated
process template
Biological Manufacturing Enzymatic Reaction
Make
1
Purify 2
Formulate
3
Chromatography
1-3 steps
UF/DF
UF/DF Inactivation Clarification
Formulation Sterile Filtration and Final Fill
Cell Amplification
Media
Preparation
Bioreactor and
Cell Growth
Nucleic Acid
Digestion
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
18. mRNA technology
Advantages
1 RNA therapeutics are safer
than DNA therapeutics
(RNA does not integrate
into the Genome)
RNA is not infectious
RNA is produced using a
cell-free enzymatic
transcription reaction or
chemical synthesis
2 Production of RNA-
based vaccines is
faster compared to
production of
traditional vaccines
Good scalability
3
Producing RNA
vaccines is less
expensive than
producing the full
antigen protein
4
For any outbreak
RNA vaccines are
more flexible, any
desired RNA for any
desired protein of
interest can be
prepared in short time
for each individual
patient (personalized
medicine)
Safety
Time
COst
Flexibility
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
18
19. mRNA technology
Challenges
1 Single stranded
Highly negatively charged
Rapid degradation of RNA
caused by endonucleases
Cold-chain
2 Exogenous mRNA is
immunostimulatory, as it is
recognized by a variety of
innate immune receptors
RNA instability
Immune modulation
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
19
21. Source: Sanofi - EVF presentation – French Bioproduction Tour - 2021
A new way to design vaccine manufacturing facilities
21 Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
22. Hybrid Modular Biologics Platform
22
A flexible and rapidly
deployable facility platform
based on a process
consensus design
philosophy.
iCON™ can be adapted to
biomanufacturing
production needs from 20L
up to multiples of 2000L
scale.
This concept allows :
• Biosafety containment between each module
• Multimodal biomanufacturing into the different modules (Different
vaccine templates / Mab process / Viral and gene therapy…)
• Flexibility to increase capacity by module addition
Source : IPS and CRB website
Process
Equipments
Modules
Facility
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
23. BallRoom concept
23
Source : SU Bioprocess Platform for Veterinary Vaccine & Biopharmaceutical
pilot scale production- Francis Verhoeye – Zoetis - June 15th 2020
Concept and requirements :
• Big room with different unit operations which can be moved according to the process needs/template
• Mobile equipment's required (to limit as much as possible) – Keep “3-meter rule” to minimize tubing length and volumes
• Full closed processing required to move from one campaign to another one or if handling multiple processes in parallel
• From BSL1 to BSL3
• Ideal for CDMO activities – Flexibility to jump from one product to another one.
• Ball room with docking
stations – Class C
• Central area for buffer and
media – Class D
Source :https://ispe.org/pharmaceutical-engineering/november-
december-2020/biopharma-facility-design-lessons-learned-dance
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
24. Process Automation / Robotization
25
Environmental
Monitoring
Water
Sampling
Product
Sampling
1000L
Bioreactor
Sample
transfer
Sub Aliquot
Insertion of
Sample for
Analysis
Kitting of
materials
Movement of
materials
Source : ISPE / Biopharma Facility Design: Lessons Learned on the Dance Floor / Nov Dec 2020
All tasks done :
- with operators in
one shift (8:00AM to
5:30PM)
- Overnight with
automation and
robotization (no
manual operations)
Manufacturing Room
Robots/Cobots can now support your manufacturing steps
Example of automation strategy for USP
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
25. Successful proof of concept project.
Next step for GSK : Replicate the
digital twin concept on an industrial
scale for its vaccine development
and manufacturing platforms.
Partnership with Siemens and Atos
to pilot a digital twin for their
vaccine manufacturing process that
modeled and controlled the adjuvant
particle manufacturing process
Digital Twin
26
Source : https://www.pharmtech.com/view/gsk-pilots-digital-
twin-for-vaccine-manufacturing
Example of GSK Vaccines
We developed Bio4C™ software for
process orchestration and automation
part of BioContinuum® Platform
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
26. Energy
CO2
Water
Reducing
environmental
footprint
On-going projects
EVF project for VACCINES
(France & Singapore)
Chemicals
Waste
CO2
Source : Sanofi Webpage
Existing Factory 4.0
Example of Sanofi for mAb
mAb facility – Former Genzyme plant
• Facility size reduction
• Number of unit operations
• Shorter cleaning circuits
• Time between two
campaigns
Major improvements
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
27
27. mRNA Conceptual Facility Design
Case study from KSA
Revamping existing facility to make new Conceptual Facility Design for the first
mRNA CDMO facility in KSA as part of a multi-modality CDMO
3D High level overview of
Warehouse + F&F Building
Warehouse + Fill & Finish building Deliverables
• Process flow diagrams
• Capacity: Batchs/yr & Doses/yr
• Equipment list
• Facility layouts with process,
waste, people, materials flow,
room classification, pressure
cascade
• APEX, OPEX
• Review and assessment of
regulatory compliance
• Optimization proposals
• 3D layouts and plans
pDNA and mRNA Facility Layout
Area
Fill & Finish / Cleaning area
mRNA production area
M/B preparation area
pDNA production area
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
28
29. Schools, universities and learning
centers will have to adapt their offer to
train the next generation of vaccine
biomanufacturers of Industry 4.0
Be prepared!
People profile
Today :
People in charge of Vaccine manufacturing are Biologists working with
automation engineer
Tomorrow :
People in charge of Vaccine manufacturing will be “BioAutomation” engineer
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
30
30. Sourcing / Supply of raw materials
31
Covid 19 impact:
Most of pharmaceutical suppliers have been dramatically impacted by the pandemic
Tomorrow :
To better secure the supply chain different options could be considered :
- Dual sourcing could become the normality but requires additional investments in time,
resources etc. to duplicate validations/qualifications
- Different stock management
- Collaboration with suppliers
• Forecast accuracy
• Stock management
• Pandemic preparedness program
• Prioritization and focus on critical materials…
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
31. !
Closed processing
32
Today :
One of the major gap today is closed processing for some specific
technologies which are difficult to close.
Chromatography is one of the most difficult step to close especially if
sterility is required (ie. Live virus vaccine):
- Column sterilization
- Resin stability with gamma irradiation
Tomorrow :
Ideally the membranes could replace chromatography columns with resin
- Self contained
- Sterilizable (Y/N?)
- Implementation possible in single-use assemblies if gamma stable
(or autoclavable?)
Fully closed
Vs
Functionally closed
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
32. Robotics
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
33
▪ Reproducibility and process
robustness improvements
▪ Development and process
time Reduction
▪ Process Platform
Towards the full automation with Robots, Cobots and AI?
34. Vaccines, empowered
“You want to scale and deliver your vaccine to the
world quickly. Our collaborative global vaccine
capabilities will take your innovation from
discovery to full-scale GMP-manufacturing
efficiently, safely, and cost-effectively.
Discover how expertise— empowered by
collaboration—can refine mRNA approaches or
overcome manufacturing challenges in more
traditional modalities.
Vaccines,
empowered
35. Our LS Bioprocessing vaccine segment
Accelerating the development & manufacturing of vaccines
Advancing manufacturing
templates
Life science technologies exploration
& POCs
Collaboration with Institutes &
private organizations to translate
processes to GMP ready
Industry collaboration &
projects
New technologies development
Process development & optimization
Tech transfers support
Vaccine focus organizations
Industry/Government groups presence,
partnerships & trainings
Publications
Dedicated application notes & web
microspace
Voice of the industry
36
Understanding the needs of the vaccine industry and
applying a holistic approach
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
36. Advancing vaccine manufacturing
Capabilities across the chain to accelerate the journey
2 Scale up
Mobius® Single-Use
assemblies or multi-use
Equipments
1 Process
development
Support & services
Incl. collaboration with
3rd parties
3 Testing &
Services
Bioreliance® testing
,Validation & CDMO,
Regulatory
consultancy services
4 Facility design
& building support
incl. partners
37
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
39. Establish Quality Management System
STAGE 1 – Quality Manual
Quality Manual will be developed by the Consultancy Principal Consultant (GMP Compliance Expert)
Quality Manual built upon ICH Q10 Pharmaceutical Quality System, will include the Quality Policy and
outline of the Quality Systems that will be defined in detail in the Master Documents to be developed
during the other project stages
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
40
Quality Manual
Quality Systems
(Standard
Master
Procedures)
Production
Governing
Procedures
Quality
Control
Master
Procedures
Validation
Program
Procedures
and Plans
Engineering
and
Maintenance
Governing
Procedures
Data
Integrity
Master
Procedures
STAGE 1
STAGE 2
STAGE 3
STAGE 4
STAGE 5
STAGE 6
STAGE 7
40. Establish Quality Management System
STAGE 2 – Quality Systems
The Standard Master Procedures will define the Quality Systems based on the organization and
functions of site.
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
41
Quality Manual
Quality Systems
(Standard
Master
Procedures)
Production
Governing
Procedures
Quality
Control
Master
Procedures
Validation
Program
Procedures
and Plans
Engineering
and
Maintenance
Governing
Procedures
Data
Integrity
Master
Procedures
STAGE 1
STAGE 2
STAGE 3
STAGE 4
STAGE 5
STAGE 6
STAGE 7
41. Establish Quality Management System
STAGE 3 – Production Governing Procedures
The Production Governing Procedures will define the Production requirements and controls based on the
role of the site, e.g. MAH or CDMO.
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
42
Quality Manual
Quality Systems
(Standard
Master
Procedures)
Production
Governing
Procedures
Quality
Control
Master
Procedures
Validation
Program
Procedures
and Plans
Engineering
and
Maintenance
Governing
Procedures
Data
Integrity
Master
Procedures
STAGE 1
STAGE 2
STAGE 3
STAGE 4
STAGE 5
STAGE 6
STAGE 7
42. Establish Quality Management System
STAGE 4 – Quality Control Master Procedures
The Quality Control Master Procedures will define the Quality Control requirements and controls, e.g.
specifications, analytical methods, samples management, environment monitoring.
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
43
Quality Manual
Quality Systems
(Standard
Master
Procedures)
Production
Governing
Procedures
Quality
Control
Master
Procedures
Validation
Program
Procedures
and Plans
Engineering
and
Maintenance
Governing
Procedures
Data
Integrity
Master
Procedures
STAGE 1
STAGE 2
STAGE 3
STAGE 4
STAGE 5
STAGE 6
STAGE 7
43. Establish Quality Management System
STAGE 5 – Validation Program Procedures and Plans
The Validation Program Procedures and Plans will define the Validation Program Procedures and Plans
requirements, e.g. validation policy, specific validation standards (facility, utility, equipment, cleaning,
process, shipping, etc.)
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
44
Quality Manual
Quality Systems
(Standard
Master
Procedures)
Production
Governing
Procedures
Quality
Control
Master
Procedures
Validation
Program
Procedures
and Plans
Engineering
and
Maintenance
Governing
Procedures
Data
Integrity
Master
Procedures
STAGE 1
STAGE 2
STAGE 3
STAGE 4
STAGE 5
STAGE 6
STAGE 7
44. Establish Quality Management System
STAGE 6 – Engineering and Maintenance Governing Procedures
The Engineering and Maintenance Governing Procedures will define the Engineering and Maintenance
requirements, e.g. preventative maintenance, calibration, spare parts management, etc.
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
45
Quality Manual
Quality Systems
(Standard
Master
Procedures)
Production
Governing
Procedures
Quality
Control
Master
Procedures
Validation
Program
Procedures
and Plans
Engineering
and
Maintenance
Governing
Procedures
Data
Integrity
Master
Procedures
STAGE 1
STAGE 2
STAGE 3
STAGE 4
STAGE 5
STAGE 6
STAGE 7
45. Establish Quality Management System
STAGE 7 – Data Integrity Master Procedures
The Data Integrity Master Procedures will define the Computer System Validation and Data Integrity
requirements, e.g. data management policy, CSV policy, account management, audit trail management,
business continuity, disaster recovery, ERES management, etc.
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
46
Quality Manual
Quality Systems
(Standard
Master
Procedures)
Production
Governing
Procedures
Quality
Control
Master
Procedures
Validation
Program
Procedures
and Plans
Engineering
and
Maintenance
Governing
Procedures
Data
Integrity
Master
Procedures
STAGE 1
STAGE 2
STAGE 3
STAGE 4
STAGE 5
STAGE 6
STAGE 7
46. 47
Qualification and Validation
Reference
QRM
Third Party
Services
Knowledge
Management
Change
control
Deviation
Management
……
Data Integrity
Support
Activity
ICH Q8
ICH Q9
ICH Q10
ICH Q11
EudraLex,
Volume 4,
Part I/Part II
EU GMP
Annex 11
EudraLex,
Volume 4,
Part I Chapter
3,5
EMA Guideline
on process
validation for
finished
products
PQS
Qualification and Validation
Procedure
VMP
VP
Organizing and
Planning for
Qualification and
Validation
URS DQ
FAT
SAT
IQ OQ PQ
Re-qualification
Equipment,
Facilities,
Utilities,
Systems
Process
CSV AV CV
PV
Validation of
Packaging
Verification of
Transportation
Leverage
FS
DS
Life Cycle
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
47. Summary
Ways Forward - Vaccine manufacturing tomorrow | Nov. 2021
1. Covid-19 and bioprocessing 4.0 accelerates the
development of vaccine Facility of the Future,
characterized by a more intensified, continuous,
predictive, and autonomous operation.
2. Vaccine manufacturing is moving into new
generation incorporating the following concepts:
a fully single-use process, closed processing,
modular facilities, and platform manufacturing.
3. Laveraging solution providers’ expertise
including QMS system establishment, regulatory
consulting, Testing services, CDMO services, and
quality products with regulatory support dossiers,
are key to reach win-win situation and speed to
market.