Innovation in Affordable CD4 Enumeration DiagnosticsAnand Sivaraman
This presentation details the systematic processes that were employed in understanding various cost components that contribute to the high cost CD4 enumeration reagents. ReaMetrix's dried down technology that enables elimination of cold-chain in storage and shipment of reagents is also discussed.
Accelerating cell therapy manufacturing through robust process development - ...MilliporeSigma
Watch the webinar here: https://bit.ly/2WFoinn
Industry trends in regenerative medicine highlight a critical need for automated and closed manufacturing to support scalable production. With over 1,000 clinical trials underway worldwide utilizing the RM/AT designation, it's increasingly more important that successful clinical trials translate to marketable treatments. To ensure proper translation, manufacturing strategies must generate products that are effective, safe, consistent and help reduce costs. To achieve this goal, fit-for-purpose solutions are required.
This webinar presents an introduction to our fit-for-purpose cell therapy manufacturing solution, the ekko™ cell processing system. We will share process development strategies through case studies that support a variety of unit operation steps across cell types, including but not limited to, wash and concentration of T cells and aggregate processing of induced pluripotent cells.
The goal of our presentation is to share process development strategies for solutions that can be seamlessly translated and implemented for use in commercial production.
In this webinar, you will learn:
* Manufacturing trends for closed and automated cell therapy processes and requirements for industrialization of cell therapies
* Introduction to acoustic cell processing and how it works
* Process optimization with case studies across a variety of cell types and unit operations
Fast-track solutions to address challenges with Host Cell Proteins in early d...Merck Life Sciences
Watch this webinar here: https://bit.ly/3fFRXDb
This webinar illustrates a customer case study about the challenges related to the removal of Host Cell Proteins from bioreactor harvest, the selected fast-track approach and outcome.
Our customer had one month to reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial. The high level of HCPs (1,000,000 in the harvest and 700 ppm at the end of purification) unfavorably impacted the planned clarification process and subsequent downstream steps.
The goal was to reduce the level of HCPs to maximum of 300 ppm at the end of process purification and ensure clarification of the entire 2000L harvest.
In this webinar, you will learn about:
- Challenges with Host Cell Proteins
- Fast-Track Approach using caprylic acid precipitation followed by filtration using Clarisolve® filters
- The impact of Design of Experiment
Watch the webinar now: http://bit.ly/scale-up-webinar
Flexibility and speed are key for the development of a new drug, from research to clinic and from clinic to market. Being able to produce a batch at the right time and at the right size is required to handle clinical trials in a fast and cost effective manner. For that purpose, a robust process is mandatory but its scalability makes a difference. During this session, we will describe our method to ensure efficient process tech transfer from a 3L to a 2000L bioreactor, straight forward. The knowledge generated during process development, as well as a specific model designed to keep the oxygen mass transfer coefficient (KLa) stable in any bioreactor, drive the success of such a challenge.
In this webinar, you will learn:
- How to modelize oxygen uptake in a bioreactor
- How to use this model and scale-up a process
- How to liaise with harvesting through clarification
Bioburden control: Strategies to address bioburden control in downstream proc...Merck Life Sciences
Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies. Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
In this webinar, you will learn:
• Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies.
• Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists.
• Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
Register for our webinar here: https://bit.ly/3c4q9rr
Accelerating COVID-19 Therapies: How a streamlined biosafety strategy can get...Merck Life Sciences
Access the interactive recording: https://bit.ly/2xB2eRs
Abstract:
Vaccine and other biologic developers have long relied on traditional, growth-based methods for the detection of adventitious agents in a biosafety testing package. However, at a time where speed is of the essence, relying on testing methods that take many weeks is a real concern. Fortunately, alternative rapid detection methods can shorten timelines significantly — especially for Phase I testing. Here we will take you through these rapid alternatives and outline a testing strategy that can bring your therapy to the clinic faster.
Innovation in Affordable CD4 Enumeration DiagnosticsAnand Sivaraman
This presentation details the systematic processes that were employed in understanding various cost components that contribute to the high cost CD4 enumeration reagents. ReaMetrix's dried down technology that enables elimination of cold-chain in storage and shipment of reagents is also discussed.
Accelerating cell therapy manufacturing through robust process development - ...MilliporeSigma
Watch the webinar here: https://bit.ly/2WFoinn
Industry trends in regenerative medicine highlight a critical need for automated and closed manufacturing to support scalable production. With over 1,000 clinical trials underway worldwide utilizing the RM/AT designation, it's increasingly more important that successful clinical trials translate to marketable treatments. To ensure proper translation, manufacturing strategies must generate products that are effective, safe, consistent and help reduce costs. To achieve this goal, fit-for-purpose solutions are required.
This webinar presents an introduction to our fit-for-purpose cell therapy manufacturing solution, the ekko™ cell processing system. We will share process development strategies through case studies that support a variety of unit operation steps across cell types, including but not limited to, wash and concentration of T cells and aggregate processing of induced pluripotent cells.
The goal of our presentation is to share process development strategies for solutions that can be seamlessly translated and implemented for use in commercial production.
In this webinar, you will learn:
* Manufacturing trends for closed and automated cell therapy processes and requirements for industrialization of cell therapies
* Introduction to acoustic cell processing and how it works
* Process optimization with case studies across a variety of cell types and unit operations
Fast-track solutions to address challenges with Host Cell Proteins in early d...Merck Life Sciences
Watch this webinar here: https://bit.ly/3fFRXDb
This webinar illustrates a customer case study about the challenges related to the removal of Host Cell Proteins from bioreactor harvest, the selected fast-track approach and outcome.
Our customer had one month to reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial. The high level of HCPs (1,000,000 in the harvest and 700 ppm at the end of purification) unfavorably impacted the planned clarification process and subsequent downstream steps.
The goal was to reduce the level of HCPs to maximum of 300 ppm at the end of process purification and ensure clarification of the entire 2000L harvest.
In this webinar, you will learn about:
- Challenges with Host Cell Proteins
- Fast-Track Approach using caprylic acid precipitation followed by filtration using Clarisolve® filters
- The impact of Design of Experiment
Watch the webinar now: http://bit.ly/scale-up-webinar
Flexibility and speed are key for the development of a new drug, from research to clinic and from clinic to market. Being able to produce a batch at the right time and at the right size is required to handle clinical trials in a fast and cost effective manner. For that purpose, a robust process is mandatory but its scalability makes a difference. During this session, we will describe our method to ensure efficient process tech transfer from a 3L to a 2000L bioreactor, straight forward. The knowledge generated during process development, as well as a specific model designed to keep the oxygen mass transfer coefficient (KLa) stable in any bioreactor, drive the success of such a challenge.
In this webinar, you will learn:
- How to modelize oxygen uptake in a bioreactor
- How to use this model and scale-up a process
- How to liaise with harvesting through clarification
Bioburden control: Strategies to address bioburden control in downstream proc...Merck Life Sciences
Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies. Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
In this webinar, you will learn:
• Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies.
• Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists.
• Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
Register for our webinar here: https://bit.ly/3c4q9rr
Accelerating COVID-19 Therapies: How a streamlined biosafety strategy can get...Merck Life Sciences
Access the interactive recording: https://bit.ly/2xB2eRs
Abstract:
Vaccine and other biologic developers have long relied on traditional, growth-based methods for the detection of adventitious agents in a biosafety testing package. However, at a time where speed is of the essence, relying on testing methods that take many weeks is a real concern. Fortunately, alternative rapid detection methods can shorten timelines significantly — especially for Phase I testing. Here we will take you through these rapid alternatives and outline a testing strategy that can bring your therapy to the clinic faster.
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...MilliporeSigma
Are you ready to accelerate biosafety testing?
The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. These traditional testing methods are often culture based and can take several weeks to produce the required result to allow for batch release. In this talk we will explore how new methods can be used to accelerate biosafety testing today, as well as how they can evolve to meet new manufacturing paradigms such as continuous processing and novel cell and gene therapy treatment modalities.
Participate in the interactive webinar now: http://bit.ly/BlazarWebinar
Explore our webinar library: www.emdmillipore.com/webinars
Process Development for Cell Therapy and Viral Gene TherapyMerck Life Sciences
Today’s viral vector manufacturing processes remain challenging. Process development is a critical enabler to bring safe, effective, sustainable products to market to address patient needs. When done properly, it can reduce the timeline of the project and the cost of producing the therapeutic product.
The webinar discusses our strategies for developing lentivirus and adeno associated virus (AAV) and the impact these early decisions can have on commercial readiness.
Watch the interactive webinar now: https://bit.ly/2VplwQq
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
Watch the on demand webinar here: https://bit.ly/3cHnFzP
All biologics production processes focus on preventing adventitious microorganisms from entering upstream processes. Regulatory guidance for upstream processes focuses on comprehensive testing and characterization of raw materials. While there is no specific mandate for implementing viral clearance technologies, manufacturers are increasingly implementing practices that mitigate the risk of contamination and the consequent disruption to manufacturing operations. This webinar will discuss the potential sources of viral contaminants, the strengths and limitations of different detection and removal technologies and explain how they can be integrated into a comprehensive, holistic, upstream viral safety strategy.
In this webinar, you will learn about:
- How integrating multiple approaches can reduce contamination risks
- Retention performance with different filters for cell culture media processing
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...MilliporeSigma
Watch this webinar here: https://bit.ly/2ZpV3GU
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics.
Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn:
• Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite
• Overview of Bioprocess lifecycle and present biomanufacturing data management challenges
• Introduction to the Bio4C™ ProcessPad digital platform and its modules and features
• Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations
How to reach High Plasma Protein Concentration with Single-Pass TFFMerck Life Sciences
This webinar will discuss our collaboration with Takeda on the development of a single-pass TFF system as an alternative to traditional TFF for concentrating a plasma-derived IgG solution.
Single-Pass Tangential Flow Filtration (SPTFF) is a technology that requires only one pass through the filter assembly to achieve the desired concentration with no recirculation of product.
SPTFF can offer many advantages in downstream processing, such as:
• Increased capacity and reduced process time
• Increased yield and product recovery
• Optimized processing of highly shear-sensitive products
• Reduced foam formation
• Reduced cost of goods
This presentation will cover our collaboration with Takeda, formerly Shire, for the development of a specific SPTFF system as an alternative to traditional TFF for concentrating a plasma-derived Immunoglobulin G (IgG) solution from 10% to 20%. Due to promising results, plans are underway to replace the currently used batch TFF process with a SPTFF step.
In this webinar, we will discuss:
- A comparison of traditional TFF versus SPTFF
- Design of Experiments (DOE) approach toward initial process development work and determination of the optimal parameters
- Process run results, including final product yield and product quality
Process development guidance for AAV and lentivirus manufacturing based on co...MilliporeSigma
Access the interactive recording here: https://bit.ly/37nl3Ex
Webinar summary:
An efficient production platform is essential for successful commercial implementation of gene therapy programs. AAV and Lentivirus manufacturing process are often developed with compressed timelines, reduced process optimization and low product yields which can have significant effect on costs.
In this webinar, you will learn:
* How manufacturing costs are examined for adeno-associated virus and lentivirus production with several different for each vector
* That key process characteristics like production titer, production of empty viral particles, downstream product recovery, and the batching strategy can effect the overall manufacturing cost
* How holistic evaluation is an important tool during process development to help prioritize different approaches to improve viral vector production processes
Abstract:
An efficient production platform is essential for successful commercial implementation of gene therapy programs. Viral vector manufacturing processes are often developed under timelines which are considerably shorter than those for more mature biopharmaceuticals. Consequently, the level of process optimization is reduced and challenges related to low product yields are common. These factors, as well as the small batch sizes common for these processes, can have significant effect on manufacturing costs.
Addressing the Challenge of Scalability in Viral VectorsMilliporeSigma
Watch this webinar here: https://bit.ly/3jlcEXH
Addressing the Challenge of Scalability in Viral Vectors
To meet the ever-increasing demands for cell and gene therapies, there is a need to shift away from expensive, labor-intensive cell culture and scale up systems. But this goal cannot be met without a robust production strategy based on clinical indication, population size and dosing requirements.
Early viral vector process development for cell and gene therapies is critical to assure a production strategy that supports commercial needs based on clinical indication, population size and dosing requirements. Most production processes today rely on labor-intensive and expensive adherent cell culture systems and scale out approaches. This webinar will highlight the importance of a scalable process that supports clinical through commercial needs. We will introduce a suspension-based process we have developed, including a HEK 293T cell line, chemically defined media, and optimized process conditions that results in higher yield, easier scalability, and lower production costs.
In this webinar, you will learn:
• Why suspension cell based processes are easier, faster, and more economical than adherent cell growth cultures
• Use of chemically defined medium for improved cellular growth, viral productivity, easier downstream purification and improved safety from adventitious agents
• Unraveling the complexities of the HEK293 and 293T cell lines
• The importance of planning for scalability and manufacturability from the earliest stages of process development
• How a scalable templated process can reduce time needed to move from product development to commercialization
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...Merck Life Sciences
As single-use technologies continue to expand in pharmaceutical manufacturing processes, the risk assessment for extractables and leachables becomes increasingly complex. Join this webinar to obtain guidance on how to perform risk evaluation on a process with multiple single-use components.
A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps-- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk.
This webinar will evaluate the different single-use components with respect to compatibility and extractables and leachables. A case study will be used to demonstrate the complexity and potential concerns when performing a risk evaluation on the manufacturing process.
In this webinar, you will learn:
- Risk assessment of extractables
- Single-use component evaluation
- Complexity when evaluating multiple assemblies
Webinar: Evaluating Viral Clearance for Continuous ProcessesMilliporeSigma
Participate in the interactive webinar now: http://bit.ly/ViralClearanceWebinar
Is viral clearance a hurdle to implementing continuous processing? We’ll share virus spiking alternatives that may pave the way for effectively evaluating viral clearance by chromatography steps in a continuous process.
Explore our webinar library: www.emdmillipore.com/webinars
Extractables profiles for chromatography resins - adapted approach of upcomin...MilliporeSigma
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.
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell...MilliporeSigma
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.emdmillipore.com/webinars
Commercializing antibody-drug conjugates: a CMO’s journeyMerck Life Sciences
Watch the webinar here: https://bit.ly/2YLDzTE
This webinar will take you through the story of a CMO preparing for the manufacture of a Commercial Antibody Drug Conjugate (ADC).
Join us to learn about how we grew as a CMO to develop a Commercial ADC program. We will walk through the full timeline from development, process risk assessment and control strategy development and validation, finishing off with preparation for a Commercial ADC Pre-Approval Inspection Audit.
In this webinar you will learn how to:
• Properly structure your development work
• Perform a thorough process risk assessment
• Prepare for pre-approval inspection
Strategic Considerations for Implementing Single-Use Technologies in Vaccine ...Dr. Priyabrata Pattnaik
Presented at DCVMN 15th Annual General Meeting, 27-October-2014 to 29-October-2014. New Delhi, India. The presentation can be downloaded from the following site.
http://www.dcvmn.org/sites/default/private_files/files/Strategic%20Considerations%20for%20Implementing%20of%20SU%20(Pattnaik).pdf
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...MilliporeSigma
Are you ready to accelerate biosafety testing?
The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. These traditional testing methods are often culture based and can take several weeks to produce the required result to allow for batch release. In this talk we will explore how new methods can be used to accelerate biosafety testing today, as well as how they can evolve to meet new manufacturing paradigms such as continuous processing and novel cell and gene therapy treatment modalities.
Participate in the interactive webinar now: http://bit.ly/BlazarWebinar
Explore our webinar library: www.emdmillipore.com/webinars
Process Development for Cell Therapy and Viral Gene TherapyMerck Life Sciences
Today’s viral vector manufacturing processes remain challenging. Process development is a critical enabler to bring safe, effective, sustainable products to market to address patient needs. When done properly, it can reduce the timeline of the project and the cost of producing the therapeutic product.
The webinar discusses our strategies for developing lentivirus and adeno associated virus (AAV) and the impact these early decisions can have on commercial readiness.
Watch the interactive webinar now: https://bit.ly/2VplwQq
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
Watch the on demand webinar here: https://bit.ly/3cHnFzP
All biologics production processes focus on preventing adventitious microorganisms from entering upstream processes. Regulatory guidance for upstream processes focuses on comprehensive testing and characterization of raw materials. While there is no specific mandate for implementing viral clearance technologies, manufacturers are increasingly implementing practices that mitigate the risk of contamination and the consequent disruption to manufacturing operations. This webinar will discuss the potential sources of viral contaminants, the strengths and limitations of different detection and removal technologies and explain how they can be integrated into a comprehensive, holistic, upstream viral safety strategy.
In this webinar, you will learn about:
- How integrating multiple approaches can reduce contamination risks
- Retention performance with different filters for cell culture media processing
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...MilliporeSigma
Watch this webinar here: https://bit.ly/2ZpV3GU
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics.
Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn:
• Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite
• Overview of Bioprocess lifecycle and present biomanufacturing data management challenges
• Introduction to the Bio4C™ ProcessPad digital platform and its modules and features
• Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations
How to reach High Plasma Protein Concentration with Single-Pass TFFMerck Life Sciences
This webinar will discuss our collaboration with Takeda on the development of a single-pass TFF system as an alternative to traditional TFF for concentrating a plasma-derived IgG solution.
Single-Pass Tangential Flow Filtration (SPTFF) is a technology that requires only one pass through the filter assembly to achieve the desired concentration with no recirculation of product.
SPTFF can offer many advantages in downstream processing, such as:
• Increased capacity and reduced process time
• Increased yield and product recovery
• Optimized processing of highly shear-sensitive products
• Reduced foam formation
• Reduced cost of goods
This presentation will cover our collaboration with Takeda, formerly Shire, for the development of a specific SPTFF system as an alternative to traditional TFF for concentrating a plasma-derived Immunoglobulin G (IgG) solution from 10% to 20%. Due to promising results, plans are underway to replace the currently used batch TFF process with a SPTFF step.
In this webinar, we will discuss:
- A comparison of traditional TFF versus SPTFF
- Design of Experiments (DOE) approach toward initial process development work and determination of the optimal parameters
- Process run results, including final product yield and product quality
Process development guidance for AAV and lentivirus manufacturing based on co...MilliporeSigma
Access the interactive recording here: https://bit.ly/37nl3Ex
Webinar summary:
An efficient production platform is essential for successful commercial implementation of gene therapy programs. AAV and Lentivirus manufacturing process are often developed with compressed timelines, reduced process optimization and low product yields which can have significant effect on costs.
In this webinar, you will learn:
* How manufacturing costs are examined for adeno-associated virus and lentivirus production with several different for each vector
* That key process characteristics like production titer, production of empty viral particles, downstream product recovery, and the batching strategy can effect the overall manufacturing cost
* How holistic evaluation is an important tool during process development to help prioritize different approaches to improve viral vector production processes
Abstract:
An efficient production platform is essential for successful commercial implementation of gene therapy programs. Viral vector manufacturing processes are often developed under timelines which are considerably shorter than those for more mature biopharmaceuticals. Consequently, the level of process optimization is reduced and challenges related to low product yields are common. These factors, as well as the small batch sizes common for these processes, can have significant effect on manufacturing costs.
Addressing the Challenge of Scalability in Viral VectorsMilliporeSigma
Watch this webinar here: https://bit.ly/3jlcEXH
Addressing the Challenge of Scalability in Viral Vectors
To meet the ever-increasing demands for cell and gene therapies, there is a need to shift away from expensive, labor-intensive cell culture and scale up systems. But this goal cannot be met without a robust production strategy based on clinical indication, population size and dosing requirements.
Early viral vector process development for cell and gene therapies is critical to assure a production strategy that supports commercial needs based on clinical indication, population size and dosing requirements. Most production processes today rely on labor-intensive and expensive adherent cell culture systems and scale out approaches. This webinar will highlight the importance of a scalable process that supports clinical through commercial needs. We will introduce a suspension-based process we have developed, including a HEK 293T cell line, chemically defined media, and optimized process conditions that results in higher yield, easier scalability, and lower production costs.
In this webinar, you will learn:
• Why suspension cell based processes are easier, faster, and more economical than adherent cell growth cultures
• Use of chemically defined medium for improved cellular growth, viral productivity, easier downstream purification and improved safety from adventitious agents
• Unraveling the complexities of the HEK293 and 293T cell lines
• The importance of planning for scalability and manufacturability from the earliest stages of process development
• How a scalable templated process can reduce time needed to move from product development to commercialization
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...Merck Life Sciences
As single-use technologies continue to expand in pharmaceutical manufacturing processes, the risk assessment for extractables and leachables becomes increasingly complex. Join this webinar to obtain guidance on how to perform risk evaluation on a process with multiple single-use components.
A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps-- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk.
This webinar will evaluate the different single-use components with respect to compatibility and extractables and leachables. A case study will be used to demonstrate the complexity and potential concerns when performing a risk evaluation on the manufacturing process.
In this webinar, you will learn:
- Risk assessment of extractables
- Single-use component evaluation
- Complexity when evaluating multiple assemblies
Webinar: Evaluating Viral Clearance for Continuous ProcessesMilliporeSigma
Participate in the interactive webinar now: http://bit.ly/ViralClearanceWebinar
Is viral clearance a hurdle to implementing continuous processing? We’ll share virus spiking alternatives that may pave the way for effectively evaluating viral clearance by chromatography steps in a continuous process.
Explore our webinar library: www.emdmillipore.com/webinars
Extractables profiles for chromatography resins - adapted approach of upcomin...MilliporeSigma
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.
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell...MilliporeSigma
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.emdmillipore.com/webinars
Commercializing antibody-drug conjugates: a CMO’s journeyMerck Life Sciences
Watch the webinar here: https://bit.ly/2YLDzTE
This webinar will take you through the story of a CMO preparing for the manufacture of a Commercial Antibody Drug Conjugate (ADC).
Join us to learn about how we grew as a CMO to develop a Commercial ADC program. We will walk through the full timeline from development, process risk assessment and control strategy development and validation, finishing off with preparation for a Commercial ADC Pre-Approval Inspection Audit.
In this webinar you will learn how to:
• Properly structure your development work
• Perform a thorough process risk assessment
• Prepare for pre-approval inspection
Strategic Considerations for Implementing Single-Use Technologies in Vaccine ...Dr. Priyabrata Pattnaik
Presented at DCVMN 15th Annual General Meeting, 27-October-2014 to 29-October-2014. New Delhi, India. The presentation can be downloaded from the following site.
http://www.dcvmn.org/sites/default/private_files/files/Strategic%20Considerations%20for%20Implementing%20of%20SU%20(Pattnaik).pdf
TGA presentation: PICS Guide for GMP and Data Integrity relating to microbiol...TGA Australia
An overview of regulatory requirements introduced as part of the new PIC/s PE009-13 Guide to Good Manufacturing Practice, specifically outlining impact on micro laboratories. Also, a summary of the new PI041-1 Data Integrity Guidance will be provided with a particular focus of Data Integrity in the laboratory
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
Turning up the Compen-DIAL: Rapid Test Methods for Cell & Gene TherapiesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3aeCPNB
Find out how we turn up the dial on quality control testing for cell and gene therapies through rapid methods for sterility, mycoplasma, and replication competent virus. We will review the current regulatory expectations as well as the benefits and limitations that come with each method.
Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes.
So how can these challenges be overcome while still meeting regulatory expectations?
In this webinar we will discuss and review suitable methods for rapid testing of short-life cell and gene therapies that may also help conserve limited production material. We will look at benefits, limitations, and regulatory expectations for various QC needs including current and future rapid methods for sterility, mycoplasma and replication competent virus.
In this webinar, you will learn:
• Why the shelf life of a cell or gene therapy product may impact your QC testing strategy
• Current regulatory expectations surrounding rapid methods for sterility, mycoplasma and replication competent virus
• Potential impacts of pursuing a non-optimal QC testing strategy
Turning up the Compen-DIAL: Rapid Test Methods for Cell & Gene TherapiesMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3aeCPNB
Find out how we turn up the dial on quality control testing for cell and gene therapies through rapid methods for sterility, mycoplasma, and replication competent virus. We will review the current regulatory expectations as well as the benefits and limitations that come with each method.
Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes.
So how can these challenges be overcome while still meeting regulatory expectations?
In this webinar we will discuss and review suitable methods for rapid testing of short-life cell and gene therapies that may also help conserve limited production material. We will look at benefits, limitations, and regulatory expectations for various QC needs including current and future rapid methods for sterility, mycoplasma and replication competent virus.
In this webinar, you will learn:
• Why the shelf life of a cell or gene therapy product may impact your QC testing strategy
• Current regulatory expectations surrounding rapid methods for sterility, mycoplasma and replication competent virus
• Potential impacts of pursuing a non-optimal QC testing strategy
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.