The document discusses the challenges that biopharmaceutical manufacturers face in ensuring operational excellence, safety, and risk mitigation given the complexity of biological production processes. It argues that these challenges can be overcome through early supplier integration, where suppliers partner with manufacturers during process development to help optimize costs, reproducibility, and safety. The document provides an example of the complexity of mammalian cell culture production processes and argues that creative supply chain solutions achieved through early supplier involvement are needed to remove constraints and find opportunities for improvements.
The Future of Bioprocessing – What you need to know.MilliporeSigma
One of the hottest topics in the biopharmaceutical industry today is “continuous bioprocessing”. Buzzwords such as “process intensification”, “next generation bioprocessing”, “process optimization”, and “integrated, connected manufacturing” are prevalent in industry conference programs and biopharma trade publications. This is no surprise considering that by 2025, it is expected that 20 percent of revenue from molecules that are still in the pipeline today will come from drugs manufactured with next generation technologies. It is estimated that roughly 35 percent of today’s commercial molecules will utilize process intensification methods within the next 5-10 years.
But what actually is next generation bioprocessing? How are industry players defining next generation bioprocessing and how will they pursue and successfully implement this approach? And is continuous bioprocessing always the ultimate end goal drug manufacturers around the globe are, or should be, striving for?
In this dedicated supplement, experts from both biologics manufacturers and from MilliporeSigma provide their insights and perspectives on the on-going paradigm shift towards next generation bioprocessing occurring in today’s and tomorrow’s biopharma landscape.
A Molecule’s Journey – Breaking Down Roadblocks to Commercial SuccessMilliporeSigma
Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. The key to this success is to make the right decisions at the right time. In this webinar, our experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. To achieve this goal, companies must navigate the complexities associated with business planning, cell line development, process development, technology, and regulatory and risk assessment.
In this webinar, you will learn:
- Key business considerations for commercial success
- Key technical considerations
- Regulatory and risk assessment considerations
Beyond Bioprocessing 4.0: The Convergence of IT, OT and Processing Technolog...Merck Life Sciences
Watch the interactive on-demand webinar here: https://bit.ly/2G8KSMu
The cost to develop and manufacture monoclonal antibodies has been highlighted as a substantial hurdle towards the widespread availability of these effective therapies for patients. Facility costs, utilization and labor are key contributing factors to the overall cost of these critical medicines. A proven method to increase utilization of a facility, increase process and quality robustness and lower overall costs of manufacturing is through the automation of a manufacturing process. The transformative impact that digital technologies have had on other industries’ manufacturing operations through IT and OT can be applied to the evolution happening in biopharma today. Examples of commonly used unit operations such as bioreactor, mixing and chromatography will be presented to illustrate incremental improvements that can be achieved today, and what the future looks like with the convergence of Operational Technology (OT), Information Technology (IT) and existing processing technologies.
In this webinar, you will learn:
- Incremental improvements that can be achieved today using process automation
- Practical examples of commonly used operations to illustrate the impact of automation
- How the automated facility will look like in the future
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving R...MilliporeSigma
The document summarizes the challenges of identifying appropriate quality raw materials for pharmaceutical applications in an evolving regulatory environment. It discusses regulatory considerations for raw materials, proposed quality attributes for different applications, and strategies for selecting suppliers and materials. The presentation notes that regulations require risk assessment and mitigation for raw materials, but there are no clear quality standards for many "non-regulated" materials. It promotes working with expert suppliers who can provide transparency, standardization, and information to facilitate regulatory compliance.
Team's Stuart Kay was invited by GEN magazine to write two articles on regenerative medicine. This is his second article and it focuses on why reducing the 'cost of goods' is so important.
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
1. The document describes a prototype tool for modeling manufacturing decisions in cell culture production.
2. It uses a hierarchical modeling approach and was implemented using object-oriented programming to model tasks, resources, and process streams with flexibility.
3. A case study demonstrates how the tool can evaluate the effects of manufacturing options on resource demands, costs, and strategic goals to help companies optimize their processes.
The Future of Bioprocessing – What you need to know.MilliporeSigma
One of the hottest topics in the biopharmaceutical industry today is “continuous bioprocessing”. Buzzwords such as “process intensification”, “next generation bioprocessing”, “process optimization”, and “integrated, connected manufacturing” are prevalent in industry conference programs and biopharma trade publications. This is no surprise considering that by 2025, it is expected that 20 percent of revenue from molecules that are still in the pipeline today will come from drugs manufactured with next generation technologies. It is estimated that roughly 35 percent of today’s commercial molecules will utilize process intensification methods within the next 5-10 years.
But what actually is next generation bioprocessing? How are industry players defining next generation bioprocessing and how will they pursue and successfully implement this approach? And is continuous bioprocessing always the ultimate end goal drug manufacturers around the globe are, or should be, striving for?
In this dedicated supplement, experts from both biologics manufacturers and from MilliporeSigma provide their insights and perspectives on the on-going paradigm shift towards next generation bioprocessing occurring in today’s and tomorrow’s biopharma landscape.
A Molecule’s Journey – Breaking Down Roadblocks to Commercial SuccessMilliporeSigma
Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. The key to this success is to make the right decisions at the right time. In this webinar, our experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. To achieve this goal, companies must navigate the complexities associated with business planning, cell line development, process development, technology, and regulatory and risk assessment.
In this webinar, you will learn:
- Key business considerations for commercial success
- Key technical considerations
- Regulatory and risk assessment considerations
Beyond Bioprocessing 4.0: The Convergence of IT, OT and Processing Technolog...Merck Life Sciences
Watch the interactive on-demand webinar here: https://bit.ly/2G8KSMu
The cost to develop and manufacture monoclonal antibodies has been highlighted as a substantial hurdle towards the widespread availability of these effective therapies for patients. Facility costs, utilization and labor are key contributing factors to the overall cost of these critical medicines. A proven method to increase utilization of a facility, increase process and quality robustness and lower overall costs of manufacturing is through the automation of a manufacturing process. The transformative impact that digital technologies have had on other industries’ manufacturing operations through IT and OT can be applied to the evolution happening in biopharma today. Examples of commonly used unit operations such as bioreactor, mixing and chromatography will be presented to illustrate incremental improvements that can be achieved today, and what the future looks like with the convergence of Operational Technology (OT), Information Technology (IT) and existing processing technologies.
In this webinar, you will learn:
- Incremental improvements that can be achieved today using process automation
- Practical examples of commonly used operations to illustrate the impact of automation
- How the automated facility will look like in the future
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving R...MilliporeSigma
The document summarizes the challenges of identifying appropriate quality raw materials for pharmaceutical applications in an evolving regulatory environment. It discusses regulatory considerations for raw materials, proposed quality attributes for different applications, and strategies for selecting suppliers and materials. The presentation notes that regulations require risk assessment and mitigation for raw materials, but there are no clear quality standards for many "non-regulated" materials. It promotes working with expert suppliers who can provide transparency, standardization, and information to facilitate regulatory compliance.
Team's Stuart Kay was invited by GEN magazine to write two articles on regenerative medicine. This is his second article and it focuses on why reducing the 'cost of goods' is so important.
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
1. The document describes a prototype tool for modeling manufacturing decisions in cell culture production.
2. It uses a hierarchical modeling approach and was implemented using object-oriented programming to model tasks, resources, and process streams with flexibility.
3. A case study demonstrates how the tool can evaluate the effects of manufacturing options on resource demands, costs, and strategic goals to help companies optimize their processes.
Supply Chain Management: Life Sciences EditionIBM HealthCare
Read responses from 23 supply chain executives from the Life Sciences industry as part of IBM's Global Chief Supply Chain Officer Study that focused on 400 face-to-face interviews with senior executives from 25 countries and 29 different industries.
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
The document discusses challenges in optimizing biomanufacturing supply chains. It summarizes that biopharmaceutical supply chains face unique risks from process variability, contamination, and testing requirements. This makes it difficult to achieve flexible just-in-time production while ensuring supply reliability. The document presents case studies where they used simulation modeling to analyze risks from contamination events and new product introductions. Their approach explicitly modeled variability to help clients optimize capacity and inventory levels while accounting for supply chain risks.
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
Single Use & Disposable Technology in BiomanufacturingPharma IQ
Single Use & Disposable Technology in Biomanufacturing
Pharma IQ Sector Report & Resources June 2011
Downloadable guide to latest developments in this field
LEARN MORE
https://www.disposablebiomanufacturingonline.com/?&shownewswindow=1&utm_source=PharmaIQ&utm_medium=SMO&mac=PMIQ_Slideshare&utm_campaign=Slideshare&utm_term=pdf
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.
The MIT Consortium on Adventitious Agent Contamination in Biomanufacturing aims to identify best practices for preventing contamination of biomanufacturing processes. The Consortium will provide a collaborative environment for member companies to share experiences and develop solutions. Initial projects include collecting and analyzing industry virus contamination data in a confidential manner to determine risk factors and mitigation strategies. The goal is to advance practices for ensuring product safety and quality.
For an unparalleled experience throughout the life cycle of your therapy, BioReliance® world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. Merck’s complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.
Scaling up industrial microbial processes is a complex endeavor that requires careful planning and execution to be successful. It involves increasing laboratory-scale processes to full commercial production levels over many years and at a high financial cost. If not approached properly, scale-up can lead to underperformance, delays, and project failure. To scale up successfully, one must begin with a clear vision of the final commercial process, be diligent in considering all critical details, and prepare for unexpected challenges that may arise.
The Emprove® Program: Introduction of New Portfolio AdditionsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3wT5Irt
The Emprove® Program is constantly expanding and updating. Find out about the recently launched Emprove® CCM category for our cell culture media portfolio, the new Emprove® API Information Packages, and the latest updates on available TUPPs for our Emprove® Chemicals portfolio.
This virtual user group will introduce the two latest additions to the Emprove® Program:
1. Our latest category Emprove® CCM for our cell culture media with wave 1 focus on our Cellvento® CHO cell culture media portfolio, looking also into the content of our three Emprove® Dossiers.
2. The new Emprove® API Information Packages that are currently created for our Emprove® APIs, looking into the content and showing how to access.
Additionally, we'll give an overview of latest Technically Unavoidable Particle Profiles (TUPPs) for our Emprove® Chemicals.
In this virtual user group, you will learn:
• Emprove® CCM and its documentation for our cell culture media
• Content and availability of the new Emprove® API Information Package
• Update on available TUPPs for our Emprove® Chemicals
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
This document summarizes discussions from a conference on continuous biomanufacturing. Key presentations discussed Amgen's goal of 5 g/L productivity using intensified processes, and the FDA's support for continuous manufacturing. Conference participants also discussed different continuous approaches like steady-state perfusion and dynamic perfusion. Integrating upstream and downstream processes continuously is an area still needing investigation. The best approach depends on a company's existing infrastructure and product portfolio.
Hi, I'm Presents a Research article for Journal club entitled with
"3D Printing: A Case of ZipDose® Technology –World’s First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product"
Reference (Source article):
1. West, Thomas & Bradbury, Thomas. (2018). 3D Printing: A Case of ZipDose® Technology - World's First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product: Process Engineering and Additive Manufacturing. https://doi.org/10.1002/9783527813704...
2. https://www.aprecia.com/technology/zipdose
This document provides guidance for GMP inspectors on inspecting sterility testing facilities and methodology. It covers key areas like clean room requirements, environmental monitoring, personnel training, sampling, and test details. The goal is to promote a consistent approach to sterility testing inspections and ensure tests are performed under optimized conditions to recover any microorganisms present. Recommendations include class A laminar flow cabinets in class B clean rooms, disinfecting surfaces, validating cleaning procedures, and defining action limits for environmental monitoring.
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...MilliporeSigma
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
An overview of the Industry Consortium on Adventitious Agent Contamination in Biomanufacturing - Administered by the Center for Biomedical Innovation at Massachusetts Institute of Technology
One of the hottest topics in the biopharmaceutical industry today is “continuous bioprocessing”. Buzzwords such as “process intensification”, “next generation bioprocessing”, “process optimization”, and “integrated, connected manufacturing” are prevalent in industry conference programs and biopharma trade publications. This is no surprise considering that by 2025, it is expected that 20 percent of revenue from molecules that are still in the pipeline today will come from drugs manufactured with next generation technologies. It is estimated that roughly 35 percent of today’s commercial molecules will utilize process intensification methods within the next 5-10 years.
But what actually is next generation bioprocessing? How are industry players defining next generation bioprocessing and how will they pursue and successfully implement this approach? And is continuous bioprocessing always the ultimate end goal drug manufacturers around the globe are, or should be, striving for?
In this dedicated supplement, experts from both biologics manufacturers and from Merck provide their insights and perspectives on the on-going paradigm shift towards next generation bioprocessing occurring in today’s and tomorrow’s biopharma landscape.
This document discusses the complexity of biopharmaceutical manufacturing. It begins by explaining that biopharmaceutical manufacturing involves living organisms which introduce inherent biological variability that is difficult to engineer out. This variability can have magnified effects and increases risks. The document then presents case studies where modeling was used to understand how small process changes could have large, unintended impacts. It argues that managing complexity requires a complete systems modeling approach using real data to identify and focus on the most impactful variables. Such an approach can increase throughput, lower risks, and accurately predict how changes may affect the system.
This document provides information about an upcoming conference on single-use bioreactors being held in London on November 1-2, 2012. The conference will feature speakers from pharmaceutical and biotech companies as well as equipment suppliers discussing topics such as using single-use bioreactors to increase flexibility, reduce costs and speed up research and development. Attendees will learn about case studies on scaling up production with disposable technology and accelerating cell culture development. The conference offers sponsorship and exhibition opportunities for companies to promote their services and products.
Retrofitting a new process to an existing facilityGBX Summits
The document describes a case study where a company called Bioproduction Group used process modeling and economic analysis to evaluate new technologies for a biopharmaceutical manufacturer's future plant designs. They created a "Plant of the Future" toolset that integrated new technologies with existing process data to accurately estimate throughputs and costs. This allowed the biopharmaceutical manufacturer to identify which new technology developments offered the best returns and minimized risks.
Supply Chain Management: Life Sciences EditionIBM HealthCare
Read responses from 23 supply chain executives from the Life Sciences industry as part of IBM's Global Chief Supply Chain Officer Study that focused on 400 face-to-face interviews with senior executives from 25 countries and 29 different industries.
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
The document discusses challenges in optimizing biomanufacturing supply chains. It summarizes that biopharmaceutical supply chains face unique risks from process variability, contamination, and testing requirements. This makes it difficult to achieve flexible just-in-time production while ensuring supply reliability. The document presents case studies where they used simulation modeling to analyze risks from contamination events and new product introductions. Their approach explicitly modeled variability to help clients optimize capacity and inventory levels while accounting for supply chain risks.
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
Single Use & Disposable Technology in BiomanufacturingPharma IQ
Single Use & Disposable Technology in Biomanufacturing
Pharma IQ Sector Report & Resources June 2011
Downloadable guide to latest developments in this field
LEARN MORE
https://www.disposablebiomanufacturingonline.com/?&shownewswindow=1&utm_source=PharmaIQ&utm_medium=SMO&mac=PMIQ_Slideshare&utm_campaign=Slideshare&utm_term=pdf
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.
The MIT Consortium on Adventitious Agent Contamination in Biomanufacturing aims to identify best practices for preventing contamination of biomanufacturing processes. The Consortium will provide a collaborative environment for member companies to share experiences and develop solutions. Initial projects include collecting and analyzing industry virus contamination data in a confidential manner to determine risk factors and mitigation strategies. The goal is to advance practices for ensuring product safety and quality.
For an unparalleled experience throughout the life cycle of your therapy, BioReliance® world-class biosafety solutions offer a full range of GMP cell banking services, cell line and virus bank characterization, viral clearance and lot release testing. Merck’s complete biosafety testing solutions, paired with our long-standing reputation for quality and expertise, will give you the mission-critical capabilities to bring safe, life-changing medicines to market.
Scaling up industrial microbial processes is a complex endeavor that requires careful planning and execution to be successful. It involves increasing laboratory-scale processes to full commercial production levels over many years and at a high financial cost. If not approached properly, scale-up can lead to underperformance, delays, and project failure. To scale up successfully, one must begin with a clear vision of the final commercial process, be diligent in considering all critical details, and prepare for unexpected challenges that may arise.
The Emprove® Program: Introduction of New Portfolio AdditionsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3wT5Irt
The Emprove® Program is constantly expanding and updating. Find out about the recently launched Emprove® CCM category for our cell culture media portfolio, the new Emprove® API Information Packages, and the latest updates on available TUPPs for our Emprove® Chemicals portfolio.
This virtual user group will introduce the two latest additions to the Emprove® Program:
1. Our latest category Emprove® CCM for our cell culture media with wave 1 focus on our Cellvento® CHO cell culture media portfolio, looking also into the content of our three Emprove® Dossiers.
2. The new Emprove® API Information Packages that are currently created for our Emprove® APIs, looking into the content and showing how to access.
Additionally, we'll give an overview of latest Technically Unavoidable Particle Profiles (TUPPs) for our Emprove® Chemicals.
In this virtual user group, you will learn:
• Emprove® CCM and its documentation for our cell culture media
• Content and availability of the new Emprove® API Information Package
• Update on available TUPPs for our Emprove® Chemicals
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
This document summarizes discussions from a conference on continuous biomanufacturing. Key presentations discussed Amgen's goal of 5 g/L productivity using intensified processes, and the FDA's support for continuous manufacturing. Conference participants also discussed different continuous approaches like steady-state perfusion and dynamic perfusion. Integrating upstream and downstream processes continuously is an area still needing investigation. The best approach depends on a company's existing infrastructure and product portfolio.
Hi, I'm Presents a Research article for Journal club entitled with
"3D Printing: A Case of ZipDose® Technology –World’s First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product"
Reference (Source article):
1. West, Thomas & Bradbury, Thomas. (2018). 3D Printing: A Case of ZipDose® Technology - World's First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product: Process Engineering and Additive Manufacturing. https://doi.org/10.1002/9783527813704...
2. https://www.aprecia.com/technology/zipdose
This document provides guidance for GMP inspectors on inspecting sterility testing facilities and methodology. It covers key areas like clean room requirements, environmental monitoring, personnel training, sampling, and test details. The goal is to promote a consistent approach to sterility testing inspections and ensure tests are performed under optimized conditions to recover any microorganisms present. Recommendations include class A laminar flow cabinets in class B clean rooms, disinfecting surfaces, validating cleaning procedures, and defining action limits for environmental monitoring.
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...MilliporeSigma
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
An overview of the Industry Consortium on Adventitious Agent Contamination in Biomanufacturing - Administered by the Center for Biomedical Innovation at Massachusetts Institute of Technology
One of the hottest topics in the biopharmaceutical industry today is “continuous bioprocessing”. Buzzwords such as “process intensification”, “next generation bioprocessing”, “process optimization”, and “integrated, connected manufacturing” are prevalent in industry conference programs and biopharma trade publications. This is no surprise considering that by 2025, it is expected that 20 percent of revenue from molecules that are still in the pipeline today will come from drugs manufactured with next generation technologies. It is estimated that roughly 35 percent of today’s commercial molecules will utilize process intensification methods within the next 5-10 years.
But what actually is next generation bioprocessing? How are industry players defining next generation bioprocessing and how will they pursue and successfully implement this approach? And is continuous bioprocessing always the ultimate end goal drug manufacturers around the globe are, or should be, striving for?
In this dedicated supplement, experts from both biologics manufacturers and from Merck provide their insights and perspectives on the on-going paradigm shift towards next generation bioprocessing occurring in today’s and tomorrow’s biopharma landscape.
This document discusses the complexity of biopharmaceutical manufacturing. It begins by explaining that biopharmaceutical manufacturing involves living organisms which introduce inherent biological variability that is difficult to engineer out. This variability can have magnified effects and increases risks. The document then presents case studies where modeling was used to understand how small process changes could have large, unintended impacts. It argues that managing complexity requires a complete systems modeling approach using real data to identify and focus on the most impactful variables. Such an approach can increase throughput, lower risks, and accurately predict how changes may affect the system.
This document provides information about an upcoming conference on single-use bioreactors being held in London on November 1-2, 2012. The conference will feature speakers from pharmaceutical and biotech companies as well as equipment suppliers discussing topics such as using single-use bioreactors to increase flexibility, reduce costs and speed up research and development. Attendees will learn about case studies on scaling up production with disposable technology and accelerating cell culture development. The conference offers sponsorship and exhibition opportunities for companies to promote their services and products.
Retrofitting a new process to an existing facilityGBX Summits
The document describes a case study where a company called Bioproduction Group used process modeling and economic analysis to evaluate new technologies for a biopharmaceutical manufacturer's future plant designs. They created a "Plant of the Future" toolset that integrated new technologies with existing process data to accurately estimate throughputs and costs. This allowed the biopharmaceutical manufacturer to identify which new technology developments offered the best returns and minimized risks.
Integrated utilization of high-throughput bioreactors & high-throughput analy...KBI Biopharma
There is a strong impetus towards rapidly advancing an increasing number of novel biotherapeutics to clinical trials. However, development of cell culture processes is labor intensive and time consuming. KBI focuses on a high throughput process development (HTPD) approach using high-throughput miniaturized bioreactors and high throughput analytics that generate growth, productivity and product quality data that match those seen with classical systems. This approach enables a significant reduction in the cell culture process development timeline and costs for investigational biopharmaceuticals to reach the clinic.
Industrial Bioprocessing Simulation and Modelling
The document discusses industrial bioprocessing, simulation, and modeling. It provides an overview of bioprocessing history and applications. Process simulation and modeling tools are used to optimize efficiency without extensive experimentation. Downstream processing aims to purify products through techniques like filtration. Process design considers product properties and impurities. Scale-up requires maintaining parameters like bed height and velocity. Career opportunities exist in engineering and science roles in biopharmaceutical industries, with salary packages ranging from 3.25-8 LPA depending on level.
SMi Group's Pharma Microbiology East Coast 2019 - updated Feb 2019Dale Butler
This document provides information about the Pharmaceutical Microbiology East Coast conference taking place from April 10-12, 2019 in Boston, USA. The conference will discuss best practices and techniques for tackling microbial control challenges in the pharmaceutical industry. Over the two-day conference and optional workshops on the third day, topics will include regulatory considerations, environmental monitoring, rapid microbial methods, sterility assurance, case studies, and risk mitigation strategies. Speakers will represent major pharmaceutical companies and provide insights on the latest industry issues and solutions. Attendees can gain expertise on key microbiological topics relevant for pharmaceutical manufacturing and product development.
The document discusses ways to accelerate vaccine development and manufacturing. It proposes adopting a template and platform approach to streamline process development. A template provides a standardized starting point for each vaccine's development process. A platform accumulates expertise across multiple vaccines using common unit operations, parameters, and facilities. This approach can speed development times, lower costs, simplify supply chains, and facilitate technology transfer and manufacturing.
The document discusses the strategy of "Defense in Depth" for increasing the robustness of biomanufacturing systems. It involves introducing redundancy to mitigate the impact of failures and ensure the system can tolerate variability and failures. The Bioproduction Group advocates using their modeling and simulation software to quantitatively evaluate different sources of variability and analyze how increased redundancy through approaches like scheduling flexibility and additional equipment can improve robustness. A case study example from Genentech showed how robustness analysis allowed optimizing existing equipment usage over installing new equipment.
Clinical Trial Logistics & Supply (2011) FbFateja
This document provides information about an upcoming clinical trial logistics and supply conference to be held in London on September 29-30, 2011. It lists key speakers from various pharmaceutical companies that will discuss topics like predictive drug supply modelling, bioequivalence studies, drug pooling strategies, quality assurance, and managing clinical trials in Eastern Europe. The document also provides details about sponsoring, exhibiting, and submitting poster presentations at the conference.
Evolving Trends in mAb Production ProcessesKBI Biopharma
Monoclonal antibodies (mAbs) have established themselves as the leading biopharmaceutical therapeutic modality. The establishment of robust manufacturing platforms are key for antibody drug discovery efforts to seamlessly translate into clinical and commercial successes. Several drivers are
influencing the design of mAb manufacturing processes. The advent of biosimilars is driving a desire to achieve lower cost of goods and globalize biologics manufacturing. High titers are now
routinely achieved for mAbs in mammalian cell culture. These drivers have resulted in significant evolution in process platform approaches. Additionally, several new trends in bioprocessing havearisen in keeping with these needs. These include the consideration of alternative expression systems, continuous biomanufacturing and non-chromatographic separation formats. This paper discusses these drivers in the context of the kinds of changes they are driving in mAb production processes.
Program - 5th Annual Biomanufacturing Summit 2013, San DiegoMark Blendheim
This document provides an agenda for the Biomanufacturing Summit 2013 conference taking place in San Diego, California. The two-day conference will include presentations, panel discussions, and workshops on topics related to biomanufacturing quality, operations, and supply chain management. Speakers will discuss strategies for developing world-class quality systems, improving biomanufacturing processes, managing supply chains in emerging markets, and other challenges in the industry. Attendees will have opportunities to network and participate in one-on-one business meetings. The agenda provides timing, speaker names and affiliations, and brief descriptions of presentation topics each session.
Validation of Tangential Flow Filtration in Biotech ProcessesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3hUKfd7
The objective of validation of a unit operation is to demonstrate with a high degree of confidence that the process performs consistently. The present seminar will focus on the validation of the unit operation of TFF and will provide an overview of the regulatory landscape, the validation master plan, approaches to membrane re-use, cleaning validation, and best practices.
In this webinar, you will learn:
• Validation of TFF
• Validation master plan
• Membrane reuse and cleaning
• TFF scale down models
Speaker: Dr. Subhasis Banerjee,
Principal Technical Application Expert, Bioprocessing APAC
This document summarizes and compares the quality assurance processes of two companies - Newell Rubbermaid and General Electric Healthcare Coils - when making design changes to product components. Both companies have rigorous and well-documented processes to ensure quality is maintained throughout the redesign process. The companies found stability in turbulent financial times by prioritizing quality assurance and collaboration between teams.
Supply Chain ManagementSupply chain management is the integratio.docxmattinsonjanel
Supply Chain Management
Supply chain management is the integration of activities that procure materials and services, transform them into intermediate goods and final products, and deliver them to customers. The production, distribution, and sale of both goods and services are bound by constraints in demand, supply, capacity, capability, and a myriad of other parameters.
In this assignment, consider the strategic implications of how an organization produces and interacts with its partners, customers, and suppliers.
Using online resources, and the Internet, research supply chain management processes. Based on your research, respond to the following:
· How can an organization optimize supply chain management to improve results and remove obstacles? Support your answer with two current examples.
Write your initial response in approximately 300–500 words. Apply APA standards to citation of sources.
(This is the assignment)
Executive Summary Presentation
In LASA 2 (M6: Assignment 2), you were asked to prepare a company analysis report, choosing one company relevant to you. In that assignment, you provided information about the company’s strategic overview, an analysis of its supply chain, a plan to improve its operating processes, and an explanation of the outcomes obtained from this plan and its impact on human resources.
In this assignment, you will create an executive summary of your findings from LASA 2. Your summary should include the following sections:
· A statement of the problem or topic
· A concise analysis of the findings and a recapitulation of any main conclusions or recommendations found in M6:Assignment 2
· Specific details to highlight or support the summary
Develop a 10-slide presentation in PowerPoint format. Apply APA standards to citation of sources.
Be sure to include the following in your presentation:
· A title slide
· An agenda slide
· A reference slide
· Headings for each section
· Speaker notes to support the content on each slide
Running head: COMPANY ANALYSIS REPORT1
COMPANY ANALYSIS REPORT13
Module 6, Assignment 2:
Company Analysis Report
Scott Jackson
Operations Management:
Solution
s to Business Challenges B6029
August 4, 2012
Supply chain analysis
A typical supply chain is a structure of organizations, people, technology, activities, information and resources engaged in conveying a product or service to customer from supplier. Supply chain involves transforming natural resources, raw material and components into a finished product that is distributed to the end customer. In complicated supply chain systems, used products may be brought back into the supply chain at any juncture where residual value is recyclable. This may involve a variety of stages. In food processing industry the supply chain stages include:
Producers (raw material producer, farmer)
Processors (processing factory)
Wholesalers
Retailers
Consumers
ProducersProcessors Wholesalers Retailers Consumer ...
The document discusses the challenges that biopharmaceutical companies face in producing complex biologic drugs at scale. It introduces Bioproduction Group's Real-Time Modeling System software, which uses advanced modeling and links to manufacturing data to help companies understand and optimize their complex biomanufacturing processes. The software accounts for variability, identifies bottlenecks, and allows "what-if" analysis to improve decision-making and maximize production. It has been developed in partnership with large biopharma firms and delivers significant cost savings for its clients.
LEM Products implements efficient manufacturing and management practices to provide identification and safety products with flexibility and certainty to customers. These practices include just-in-time production, kanban systems, lean operations, and Six Sigma quality control methods. This allows LEM to meet customer demands with low minimum orders, quick response times, customization capabilities, and consistent high quality products, eliminating waste for both customers and LEM in the supply chain.
Debottlenecking a bulk manufacturing plantGBX Summits
The document describes a case study where a simulation model was used to improve throughput at a biopharmaceutical manufacturing facility. The model identified bottlenecks by exploring the impact of individual activities on facility performance and key performance indicators. This allowed the manufacturer to focus on supporting operations rather than expensive main operations, improving throughput by 15% at low cost.
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In World Expo 2010 Shanghai – the most visited Expo in the World History
https://www.britannica.com/event/Expo-Shanghai-2010
China’s official organizer of the Expo, CCPIT (China Council for the Promotion of International Trade https://en.ccpit.org/) has chosen Dr. Alyce Su as the Cover Person with Cover Story, in the Expo’s official magazine distributed throughout the Expo, showcasing China’s New Generation of Leaders to the World.
NIMA2024 | De toegevoegde waarde van DEI en ESG in campagnes | Nathalie Lam |...BBPMedia1
Nathalie zal delen hoe DEI en ESG een fundamentele rol kunnen spelen in je merkstrategie en je de juiste aansluiting kan creëren met je doelgroep. Door middel van voorbeelden en simpele handvatten toont ze hoe dit in jouw organisatie toegepast kan worden.
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Explore the details in our newly released product manual, which showcases NEWNTIDE's advanced heat pump technologies. Delve into our energy-efficient and eco-friendly solutions tailored for diverse global markets.
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During the budget session of 2024-25, the finance minister, Nirmala Sitharaman, introduced the “solar Rooftop scheme,” also known as “PM Surya Ghar Muft Bijli Yojana.” It is a subsidy offered to those who wish to put up solar panels in their homes using domestic power systems. Additionally, adopting photovoltaic technology at home allows you to lower your monthly electricity expenses. Today in this blog we will talk all about what is the PM Surya Ghar Muft Bijli Yojana. How does it work? Who is eligible for this yojana and all the other things related to this scheme?
1. White Paper
Supplier-Integrated Support of Biopharmaceutical
Raw Material Systems Promotes Operational
Excellence and Risk Mitigation
Abstract
The biopharmaceutical industry is increasingly The challenge for biopharmaceutical manufacturers
engaged with concerns about operational excellence, to become more efficient and safe is daunting,
safety and risk mitigation. These issues have considering the large number of raw materials required
historically affected large-scale pharmaceutical for production and the complexities of cell culture
manufacturing but now are gaining prominence systems. However, this challenge can be overcome
throughout biological production scale-up and if manufacturers partner with knowledgeable and
process transfer. SAFC Biosciences® provides experienced suppliers early in process development.
biopharmaceutical clients with supply chain solutions
through novel applications of vendor-partnered The Challenge
capabilities. This paper presents strategic approaches Unlike small-molecule pharmaceutical for which a
to biopharmaceutical process optimization through chemical reaction remains relatively constant through
supplier integration that maximize revenue, reduce production scale-up, bench-top biopharmaceutical
costs and support reproducibility of production experiments are not necessarily linear to large-scale
processes. It also describes how vendor-partnered manufacture because the processes are much more
solutions deliver leaner and safer processes for raw complex. Biopharmaceutical processes require
material handling. stepwise technology transfers, often with unique
processing steps, in order to ensure that the same
Introduction product is produced at large scale as at small
The biopharmaceutical industry is experiencing a new scale. This stepwise process makes developing
paradigm in which risk mitigation and operational biopharmaceutical processes expensive and
excellence are prevalent trends. It is no longer enough time-consuming and highlights the need for producers
to develop and produce a blockbuster drug candidate; to investigate integrated supply chain solutions early in
it is now critical to effectively manage costs, in-process the development process to ensure cost-effective,
quality, operational safety and supply chain security. safe, and reproducible systems.
No longer is it important to just develop and Recent industry conferences have presented many
produce a blockbuster drug candidate. examples of the impact of increased costs from
biopharmaceutical technology transfer and added
production system complexities. These presentations
To help manage the complexity, SAFC Biosciences
have shown that raw material costs are now less
offers strategic supply chain solutions that assure
of a concern than the overall operational costs for
batch quality and consistency during manufacture,
determining and applying process steps.
support complex regulatory compliance and reduce
shipping delays, so you stay on time to market and
maximize financial results.
www.safcbiosciences.com
2. Unchecked variability in technology transfer and The impact on the manufacturing routine of adding
production make it difficult to effectively manage multiple components to the production system is not
production resources. Assume, for example, that a completely understood until the entire operational
10,000 L production tank is worth about $10 process is reviewed. This full process includes initial
million in drug product. +/- 10% due to raw receipt and preparation of raw materials, quality control
material or process variability translates testing and charging components for manufacture.
into +/- $1 million in final product.
Each step pictured on the following page details the
If capacity and resource constraints limit cell Total Cost of Ownership (TCO) for each raw material
culture and purification runs by 10% a year, a incorporated into the production process, including:
potential of $50 million in loss revenue is at risk
• Logistics, sourcing and documentation
and/or may lead to increased production costs from
• Inbound receiving steps
outsourcing production to a contract manufacturer.
• Unit sampling
• QC testing
• How can resources be maximized?
• Inventory and tracking
• How can secure supplies of raw
• Media hydration and clean-up time
materials be maintained?
• How can suppliers be better integrated
into overall processes?
Adding to the challenge of complex biopharmaceutical
systems is the desire for manufacturing facilities to be
more flexible. The reality is that more clinical projects
are filling the pipeline but fewer on-site resources are
available to maximize production output.
Below is an example of the complexity that faces
biopharmaceutical production engineers. Steps
required for production in mammalian-based system
can include several feed additions that require time
point-specific supplementation:
The Integrated Supplier Approach
In a February 2006 BioProcess International article,
“Managing a Biopharmaceutical Supply Chain,” Allen
Jacques, Senior Director of BioPharma Supply Chain at
Wyeth, points out the differences and complexities
between classical pharmaceutical production systems
and present day biopharmaceutical systems. His point
is illustrated in the following image (see next page) that
compares molecule sizes of the rheumatoid arthritis
biopharmaceutical, ENBREL, to the legacy small
molecule drug Ibuprofen.
www.safcbiosciences.com
3. ENBREL Creative supply chain solutions are best achieved
when potential suppliers are integrated early-on into
manufacturing processes. For many organizations, this
means during process development At this point,
suppliers and manufacturers can become intimately
connected in a focused approach to long-term process
and resource optimization. This interconnected focus
approach allows biopharmaceutical manufacturers
This statement holds true for all to backwards-integrate with suppliers, positively
elements of supply chain and influencing the direction and effectiveness of
manufacturing. Creativity is supplier-partner solutions.
required to remove constraints
currently inhibiting process Understanding the following process scenario is
optimization and open opportunities required before actively pursuing and integrating
for cost savings, enhanced suppliers into your production processes:
reproducibility of production
• Map your entire process from development through
processes, and greater safety.
theoretical production scale
• Identify the points where suppliers currently touch
your process
“It is easy to focus on such differences
• Identify areas on the map that currently
in our industry as reasons why classical
cause constraints
supply chain principles do not apply. I
• Begin scenario planning to identify the most likely,
suggest they are applicable; they just need
and worst, operation cases that may affect your
to be applied with a measure of creativity.”
process efficiency and safety
Allen Jacques, Wyeth
www.safcbiosciences.com
4. Identify Proven Results
1. How much drug product will be required for A biopharmaceutical manufacturer for whom SAFC
clinical trials? Biosciences is a primary supplier of critical raw
2. How much drug product will be required for market materials requested that we work to develop a solution
commercialization? to an operational challenge they posed:
3. How robust and effective is your current process in
Challenge
meeting production goals?
• Enhance logistic
4. What is your production capacity?
operations capacity
5. What additional process development steps may be
- Drum dumping
required to reach your production goals?
process not
6. What is the outlook for your Bill of Materials (BOM)?
optimized
7. How will additional raw material requirements
- Dispensing 3,500 kg
and processing steps affect your Total Cost
- 7,000 repetitions
of Ownership?
Process Diagram presented by
Sartorius Stedim Biotech
Once you understand the various scenarios that may
impact your commercialization process, you can begin
identifying those suppliers best positioned to enhance
your production and operational goals. Use the
following criteria:
1. What are your BOM needs?
2. Which suppliers provide the majority of your
BOM needs?
3. What are your operational constraints regarding
raw material supply and production utilization? Solution
4. Which suppliers are focused on the industrial cell • New filling regime and supplier-managed net
culture market and can provide custom solutions weighing
for your application? - Removed two non-value steps
5. Which suppliers have risk mitigation practices
similar to your own? Powder Filling Machine
6. Which suppliers can integrate with other suppliers Servo Driven Auger Filler
to provide the optimal solution? • Programmable
Logic Control
Scale Feedback
• Multiple Tooling Sets
www.safcbiosciences.com
5. Benefits
• Reduced ergonomic safety risks and non-core To learn more about examples of how SAFC
labor hours Biosciences has integrated with manufacturers to
- Reduced customer dispensing steps by 50%; enhance production efficiency, supply chain security
reduced handling exposure and operational safety, visit www.safcbiosciences.
- Reduced wasted labor hours from 80 to less than com and click on Case Studies & White Papers in the
20 a week
Technical Library in the Overview section.
Recognizing the value of
To learn more about application-specific solutions
this supplier-integrated
to enhance your process efficiency, visit
relationship, the
customer asked how www.safcbiosciences.com.
SAFC Biosciences
Written by Mason Williams, Product Manager, SAFC; edited by
could further improve Brad Riesenberger, Sigma-Aldrich Corporate Communications
manufacturing efficiency
and supply chain
security. This launched a
new collaborative effort
About SAFC Biosciences: SAFC Biosciences is a leading
in which:
provider of cell culture materials and development services for
• Raw material risk mitigation steps have been upstream and downstream processes in the biopharmaceutical
defined for each raw material in the media industry. Providing an integrated services package in
formulation mammalian cell culture media development, along with
analytical and regulatory support, SAFC Biosciences employs
• A three-phase dry powder media transfer approach
a wealth of industry experience and scientific know-how to
has been recommended, consisting of: deliver reliable, consistent solutions that accelerate customer
Phase 1: A powder transfer bag system to ensure success – from development through to commercialization. The
powder delivery and safety in a timely manner unit has a 35-year history as a manufacturing partner providing
Phase 2: A drum dumper process that relieves leading biopharmaceutical companies with the broadest range
manual addition steps of highly customized products and services possible.
Phase 3: Design and application of a flexible bulk
About SAFC: SAFC is the custom manufacturing and services
intermediate contaminant unit to provide as few as
group within Sigma- Aldrich that focuses on high-purity
one media addition steps, reducing QC sampling
inorganics for high technology applications, cell culture
requirements and personnel handling steps. Note:
products and services for biopharmaceutical manufacturing,
Final phase requires capability development and
biochemical production and the manufacturing of complex,
continual collaborationIdentify
multi-step organic synthesis of APIs and key intermediates.
SAFC has manufacturing facilities around the world dedicated
SAFC Biosciences Integrated Supplier Approach
to providing manufacturing services for companies requiring
SAFC Biosciences offers the world’s broadest
a reliable partner to produce their custom manufactured
range of products, services and capabilities for the
materials. SAFC has four focus areas – SAFC Pharma® , SAFC
biopharmaceutical industry. SAFC Biosciences partners Supply Solutions® , SAFC Biosciences® , and SAFC Hitech® –
with other suppliers, including Sartorius Stedim Biotech, and had annual sales of $624 million in 2008. SAFC is one
Vivalis and Novozymes, to provide integrated solutions of the world’s 10 largest fine chemical businesses. For more
that impart unmatched value to the industry. information about SAFC, visit www.safcglobal.com.
United States Europe Asia Pacific
SAFC Biosciences, Inc. SAFC Biosciences Ltd. SAFC Biosciences Pty. Ltd.
13804 W. 107th Street Smeaton Road, West Portway 18-20 Export Drive
Lenexa, Kansas 66215 Andover, Hampshire SP10 3LF Brooklyn, Victoria 3025
USA UNITED KINGDOM AUSTRALIA
Phone +1 913-469-5580 Phone +44 (0)1264-333311 Phone +61 (0)3-9362-4500
Toll free-USA 1 800-255-6032 Fax +44 (0)1264-332412 Toll free-AUS 1 800-200-404
Fax +1 913-469-5584 E-mail info-eu@sial.com Fax +61 (0)3-9315-1656 10736-509241
E-mail info-na@sial.com E-mail info-ap@sial.com 0129
www.safcbiosciences.com