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Biopharmaceutical Raw Materials throughout the Product Lifecycle
CSS
Strategies to Identify, Test, Control and Mitigate Risk of Raw Material Variability in Upstream/Downstream Development and Clinical/Commercial Manufacturing
Alternate Language Options:
February 27 - 28, 2012 · Hilton San Diego Bayfront Hotel · San Diego, CA
Agenda
Monday | Tuesday
8:30
Chairperson's Welcome and Opening Remarks
Abdul Wajid, Ph.D., Senior Director, Process Sciences, XOMA (US) LLC
Abdul Wajid, Ph.D., Senior Director, Process Sciences, XOMA (US) LLC
Strategies for Raw Material Variability Testing, Characterization and Control
8:40
Strategies to Reduce Production Disturbances and Performance Variability Introduced by Raw Materials used in Product Manufacturing Operations
Raw materials (RM) are typically selected at the early developmental stages of a product's lifecycle. This RM has significant contribution to the product process performance; therefore, understanding of RM quality attributes is of utmost importance to avoid impacting biopharmaceutical manufacturing operations. As often happens, raw materials are selected without the proper synchronization of material quality attributes with the manufacturing processes which later affect the biopharmaceutical product. Less often, customers may introduce alternate suppliers of the same RM which can introduce additional source variability. Care most be taken to reduce the impact to manufacturing operations by implementing risk mitigation strategies that consist of robust supplier relationships and open communication channels to enhance the technical transparency. These actions will support establishment of aligned quality systems, and complete process understanding to ensure that appropriate testing/inspection is conducted on RM prior impacting the manufacturing processes and final products. This presentation illustrates and reviews approaches aimed to improve quality, increase reliability and reduce variability to drive mutual productivity improvements for the biopharmaceutical product and the RM supplier.
Victor J. Melendez Colon, Ph.D., Principal Scientist, Process Development, Amgen Manufacturing, Limited, Puerto Rico
Raw materials (RM) are typically selected at the early developmental stages of a product's lifecycle. This RM has significant contribution to the product process performance; therefore, understanding of RM quality attributes is of utmost importance to avoid impacting biopharmaceutical manufacturing operations. As often happens, raw materials are selected without the proper synchronization of material quality attributes with the manufacturing processes which later affect the biopharmaceutical product. Less often, customers may introduce alternate suppliers of the same RM which can introduce additional source variability. Care most be taken to reduce the impact to manufacturing operations by implementing risk mitigation strategies that consist of robust supplier relationships and open communication channels to enhance the technical transparency. These actions will support establishment of aligned quality systems, and complete process understanding to ensure that appropriate testing/inspection is conducted on RM prior impacting the manufacturing processes and final products. This presentation illustrates and reviews approaches aimed to improve quality, increase reliability and reduce variability to drive mutual productivity improvements for the biopharmaceutical product and the RM supplier.
Victor J. Melendez Colon, Ph.D., Principal Scientist, Process Development, Amgen Manufacturing, Limited, Puerto Rico
9:25
Implementing QbD and PAT Approaches to a Raw Material Control Strategy for Ensuring Critical Raw Material Authenticity and Quality
Ji Zheng, Ph.D., Senior Scientist, Allergan, Inc.
Ji Zheng, Ph.D., Senior Scientist, Allergan, Inc.
10:00
Networking Refreshment Break and Opening of Exhibit & Poster Hall
Case Studies and Experiences in Process Development and Manufacturing
10:45
Assessment of Variability in Upstream Media and Feed Change and its Impact on Antibody Cell Line Performance and Quality Attributes
XOMA has proprietary XJEM production media and corresponding feed, which are used in multiple antibody production processes manufactured by a vendor. Both basal medium and feed are critical raw materials for a phase III antibody manufacturing process. The vendor changed production process by enhancing the milling process used for both raw materials. Additionally, there was a change in manufacturing site for better segregation of animal component free media production. Both vendor-driven changes could compromise performance of these critical raw materials due to variability. The raw material had to be assessed in-house based on proprietary cell line(s) and associated expression systems; in addition the vendor's own assessment. A comprehensive case study will be presented involving XOMA's two step approach for evaluation of critical media change using fed batch shake flask studies followed by scale down bioreactor(s) studies using relevant cell line for growth, productivity and quality of antibody produced.
Abdul Wajid, Ph.D., Senior Director, Process Sciences, XOMA (US) LLC
XOMA has proprietary XJEM production media and corresponding feed, which are used in multiple antibody production processes manufactured by a vendor. Both basal medium and feed are critical raw materials for a phase III antibody manufacturing process. The vendor changed production process by enhancing the milling process used for both raw materials. Additionally, there was a change in manufacturing site for better segregation of animal component free media production. Both vendor-driven changes could compromise performance of these critical raw materials due to variability. The raw material had to be assessed in-house based on proprietary cell line(s) and associated expression systems; in addition the vendor's own assessment. A comprehensive case study will be presented involving XOMA's two step approach for evaluation of critical media change using fed batch shake flask studies followed by scale down bioreactor(s) studies using relevant cell line for growth, productivity and quality of antibody produced.
Abdul Wajid, Ph.D., Senior Director, Process Sciences, XOMA (US) LLC
11:30
Effective Analytical Strategies to Control Lot-to-Lot Variability of Hydrolysates and to Resolve Nonconformance Issues Caused by Critical Raw Materials Used in Biopharmaceutical Commercial Manufacturing
Biopharmaceutical manufacturing faces the risks and challenges introduced by raw materials (RMs) that have significant adverse impact on productivity and product attributes. This presentation reviews the strategies for identifying, testing and sourcing such RMs as risk mitigation throughout the product life cycle. Combined approaches of NMR spectroscopy and Multivariate Data Analysis (MVDA) were developed in-house and produced calibration models that successfully screened hydrolysate lots for multiple products based on the correlations between fingerprinting of RMs and their impact on cell culture performance. Case studies are presented on authenticity and quality control of critical RMs involving excipients and a PEGylation reagent.
Ying Luo, Ph.D., Senior Scientist, Product and Process Development, Amgen, Inc.
Biopharmaceutical manufacturing faces the risks and challenges introduced by raw materials (RMs) that have significant adverse impact on productivity and product attributes. This presentation reviews the strategies for identifying, testing and sourcing such RMs as risk mitigation throughout the product life cycle. Combined approaches of NMR spectroscopy and Multivariate Data Analysis (MVDA) were developed in-house and produced calibration models that successfully screened hydrolysate lots for multiple products based on the correlations between fingerprinting of RMs and their impact on cell culture performance. Case studies are presented on authenticity and quality control of critical RMs involving excipients and a PEGylation reagent.
Ying Luo, Ph.D., Senior Scientist, Product and Process Development, Amgen, Inc.
Technology Workshop
12:15
Quality of human cells and tissue are a major determinant of final product characteristics, but is complicated by the inherent heterogeneity and inter-individual variability of living biologics and inconsistent collection procedures. Rigorous application of quality systems and GMPs/GTPs enables collection of consistent, controlled apheresis products.
Scott R. Burger, M.D., Chairman, Scientific Advisory Board, HemaCare Corporation
12:45
Networking Luncheon in Exhibit & Poster Hall
2:00
Chairperson's Remarks
Matt Osborne, Ph.D., Cell Culture Technical Lead, Eli Lilly S.A, Ireland
Matt Osborne, Ph.D., Cell Culture Technical Lead, Eli Lilly S.A, Ireland
2:10
HPLC/UPLC Methods for the Testing and Characterization of Polysorbates
Raw material polysorbates are complex mixtures that have been difficult to characterize. We have developed several HPLC and UHPLC methods to accurately quantitate polysorbate in solutions and drug products as well as characterize the many species present in polysorbates. We utilize several detection techniques, such as evaporative light scattering detection (ELSD), charged aerosol detection (CAD), and mass spectrometry (MS). These methods have been implemented into both GMP and R&D environments. Using these methods, it was found that increasing rates of hydrolysis were observed with decreasing aliphatic chain lengths in polysorbate 20. Conversely, oxidative stress yielded the opposite result. We are continuing to work to understand the effects of polysorbate heterogeneity and variability on our drug products. These methods have been valuable tools to help us understand the potential routes of degradation in active products by determining the patterns of polysorbate degradation in placebo samples.
Daniel Hewitt, Senior Research Associate, Protein Analytical Chemistry, Genentech, Inc.
Raw material polysorbates are complex mixtures that have been difficult to characterize. We have developed several HPLC and UHPLC methods to accurately quantitate polysorbate in solutions and drug products as well as characterize the many species present in polysorbates. We utilize several detection techniques, such as evaporative light scattering detection (ELSD), charged aerosol detection (CAD), and mass spectrometry (MS). These methods have been implemented into both GMP and R&D environments. Using these methods, it was found that increasing rates of hydrolysis were observed with decreasing aliphatic chain lengths in polysorbate 20. Conversely, oxidative stress yielded the opposite result. We are continuing to work to understand the effects of polysorbate heterogeneity and variability on our drug products. These methods have been valuable tools to help us understand the potential routes of degradation in active products by determining the patterns of polysorbate degradation in placebo samples.
Daniel Hewitt, Senior Research Associate, Protein Analytical Chemistry, Genentech, Inc.
2:50
A Framework for Management of Chromatography Resin Lot-to-Lot Variability Based on Process Characterization
Quality by Design highlights the need for better process understanding, both regarding Critical Process Parameters and Critical Raw Material Attributes (CMA). Chromatographic resins contain several potential CMA's and we are developing a multifaceted framework that not only contains dedicated process characterization studies but also an intensified supplier – user relationship on raw material attributes. The framework will be illustrated by a process characterization study in 96-well filter plates with resin batches that cover the entire ligand density specification range. Ligand density is one of the top CMA candidates as it can affect chromatographic selectivity. The approach should be contrasted to resin screening where different resins are compared, as in this case all ligand density variants reflect the normal manufacturing variation within one resin product. Batch uptake experiments are used to establish the effect of ligand density and mobile phase conditions on CQA's. The study includes process parameter adaptation by looking for parameter interactions that allow a control strategy where the effect of ligand density variations can be counteracted by changing other factors, e.g. mobile phase conditions. The proposed approach outperforms conventional testing of a few resin lots from normal production by explicitly investigating a potential CMA. This will lead to a more robust downstream process, better process economy and increased security of supply by eliminating the need for resin lot picking.
Gunnar Malmquist, Ph.D., Staff Scientist, GE Healthcare, Sweden
Quality by Design highlights the need for better process understanding, both regarding Critical Process Parameters and Critical Raw Material Attributes (CMA). Chromatographic resins contain several potential CMA's and we are developing a multifaceted framework that not only contains dedicated process characterization studies but also an intensified supplier – user relationship on raw material attributes. The framework will be illustrated by a process characterization study in 96-well filter plates with resin batches that cover the entire ligand density specification range. Ligand density is one of the top CMA candidates as it can affect chromatographic selectivity. The approach should be contrasted to resin screening where different resins are compared, as in this case all ligand density variants reflect the normal manufacturing variation within one resin product. Batch uptake experiments are used to establish the effect of ligand density and mobile phase conditions on CQA's. The study includes process parameter adaptation by looking for parameter interactions that allow a control strategy where the effect of ligand density variations can be counteracted by changing other factors, e.g. mobile phase conditions. The proposed approach outperforms conventional testing of a few resin lots from normal production by explicitly investigating a potential CMA. This will lead to a more robust downstream process, better process economy and increased security of supply by eliminating the need for resin lot picking.
Gunnar Malmquist, Ph.D., Staff Scientist, GE Healthcare, Sweden
3:30
Networking Refreshment Break in Exhibit & Poster Hall
4:00
Case
Study
Development of a Raw Material Control Strategy for Use at Multiple Manufacturing SitesStudy
Matt Osborne, Ph.D., Cell Culture Technical Lead, Eli Lilly S.A, Ireland
4:30
Toward the use of Statistical Modeling to Predict Cell Culture Performance of Hydrolysates
Hydrolysates are composed of many different components. Predicting culture performance of a individual lot remains difficult. FrieslandCampina Domo is developing an analytical tool that predicts cell culture performance for a particular hydrolysate lot. Our QbD project has provided compositional information, also cell culture performance of 100 different lots of animal-free hydrolysates. FrieslandCampina Domo is using a statistical approach for developing a predictive model for cell culture performance. Working with our customers, it may be possible to select a hydrolysate for their individual needs. We share our findings on this topic.
Jan-Willem Boots, Ph.D., Innovation Manager Life Sciences & Cell Culture, FrieslandCampina Ingredients Innovation, The Netherlands
Hydrolysates are composed of many different components. Predicting culture performance of a individual lot remains difficult. FrieslandCampina Domo is developing an analytical tool that predicts cell culture performance for a particular hydrolysate lot. Our QbD project has provided compositional information, also cell culture performance of 100 different lots of animal-free hydrolysates. FrieslandCampina Domo is using a statistical approach for developing a predictive model for cell culture performance. Working with our customers, it may be possible to select a hydrolysate for their individual needs. We share our findings on this topic.
Jan-Willem Boots, Ph.D., Innovation Manager Life Sciences & Cell Culture, FrieslandCampina Ingredients Innovation, The Netherlands
Strategies for Single Use and Disposable "Raw Materials"
5:00
Change Management for Single Use "Raw Materials"
Changes in single use raw materials are inevitable; assembly components, materials of construction and manufacturing locations change with quality and business needs. These changes must be managed to ensure they are communicated, approved and implemented in a timely manner with minimal interruption to the end user. We will discuss guidelines and best practice that ensure informed partnerships between end users and suppliers/manufacturers. A case study will be presented that shows tracking possible changes of a key fluid contact surface as part of a single use disposable assembly.
Trishna Ray-Chaudhuri, Ph.D., Senior QC Associate II, Raw Materials/Pharm Tech Quality Biologics Product, Genentech, Inc.
Changes in single use raw materials are inevitable; assembly components, materials of construction and manufacturing locations change with quality and business needs. These changes must be managed to ensure they are communicated, approved and implemented in a timely manner with minimal interruption to the end user. We will discuss guidelines and best practice that ensure informed partnerships between end users and suppliers/manufacturers. A case study will be presented that shows tracking possible changes of a key fluid contact surface as part of a single use disposable assembly.
Trishna Ray-Chaudhuri, Ph.D., Senior QC Associate II, Raw Materials/Pharm Tech Quality Biologics Product, Genentech, Inc.
5:30
Cocktail Reception in Exhibit & Poster Hall
Monday | Tuesday
8:20
Chairperson's Remarks
Horst Ruppach, Ph.D., Global Manager of Viral Clearance and Global Coordinator Virology, Charles River Biopharmaceutical Services, Germany
Horst Ruppach, Ph.D., Global Manager of Viral Clearance and Global Coordinator Virology, Charles River Biopharmaceutical Services, Germany
Mitigating Risk of Raw Material Contamination by Adventitious Agents
Session Sponsor:
8:30
Risk Assessment and Management for Adventitious Agents in Raw Materials Used in the Biopharmaceutical Industry
Conducting a risk assessment for adventitious agent contamination (viruses, mycoplasmas, bacteria and fungi) in raw materials used in the biopharmaceutical process requires a science based approach to risk assignment. Just like in the insurance business, actuary tables can be developed to aid in determining risk for adventitious agent contamination of raw materials. This presentation will provide a basis for developing such tables to aid in determining the risk of adventitious agent contamination in the biopharmaceutical industry.
Barbara J. Potts, Ph.D., Senior Consultant, Potts and Nelson Consulting, LLC
Conducting a risk assessment for adventitious agent contamination (viruses, mycoplasmas, bacteria and fungi) in raw materials used in the biopharmaceutical process requires a science based approach to risk assignment. Just like in the insurance business, actuary tables can be developed to aid in determining risk for adventitious agent contamination of raw materials. This presentation will provide a basis for developing such tables to aid in determining the risk of adventitious agent contamination in the biopharmaceutical industry.
Barbara J. Potts, Ph.D., Senior Consultant, Potts and Nelson Consulting, LLC
9:00
A Holistic Approach for Mitigating Risk of Adventitious Agents in Raw Materials
Ivar J. Kljavin, Ph.D., Associate Director, QC Virus, Mycoplasma and Adventitious Agent Management, Genentech, Inc., a member of the Roche Group
Ivar J. Kljavin, Ph.D., Associate Director, QC Virus, Mycoplasma and Adventitious Agent Management, Genentech, Inc., a member of the Roche Group
9:30
Testing Raw Materials for Adventitious Agents Prior to Use in Manufacturing
Sridhar Pennathur, Ph.D., Senior Director, Biosafety Testing, Department of Quality Control, MedImmune, Inc.
Sridhar Pennathur, Ph.D., Senior Director, Biosafety Testing, Department of Quality Control, MedImmune, Inc.
10:00
Networking Refreshment Break in Exhibit & Poster Hall
10:45
Methods for the Identification and Reduction of Adventitious Agent Risks in Raw Materials for Live Virus Vaccine Manufacturing
Adventitious agents in vaccine and biological products have been an area of concern to regulatory agencies, manufacturers, and public health officials since the issue first arose in the early 1900s. While vaccines and the raw materials used during vaccine production are manufactured and tested in compliance with current regulations; quality control tests are broad, non-specific, and may not be capable of detecting novel or emerging adventitious agents. The possibility of adventitious agent contaminations of licensed products has recently been brought to light through the use of new analytical technologies. Such non-biased, highly sensitive technologies have been able to detect adventitious agent contaminations where conventional methods have failed to detect them. In response to these events, vaccine manufacturers have had to re-evaluate adventitious agent risks in their manufacturing processes. Legacy live virus vaccine processes are dependent on animal derived raw materials; removing animal derived raw materials from these processes, if possible, can take >10 years to realize. As such, Merck & Co. has developed a systematic approach to evaluate adventitious agent risks associated with the use of animal derived raw materials in live virus vaccine manufacturing. This approach includes the combination of FMEA and the development of a novel raw material screening program to identify adventitious agent risks in animal derived raw materials. Potential strategies for remediating the identified adventitious agent risks are also presented.
Tara Tagmyer, Ph.D., Process Scientist, Vaccine Manufacturing Sciences & Commercialization, Merck & Co.
Adventitious agents in vaccine and biological products have been an area of concern to regulatory agencies, manufacturers, and public health officials since the issue first arose in the early 1900s. While vaccines and the raw materials used during vaccine production are manufactured and tested in compliance with current regulations; quality control tests are broad, non-specific, and may not be capable of detecting novel or emerging adventitious agents. The possibility of adventitious agent contaminations of licensed products has recently been brought to light through the use of new analytical technologies. Such non-biased, highly sensitive technologies have been able to detect adventitious agent contaminations where conventional methods have failed to detect them. In response to these events, vaccine manufacturers have had to re-evaluate adventitious agent risks in their manufacturing processes. Legacy live virus vaccine processes are dependent on animal derived raw materials; removing animal derived raw materials from these processes, if possible, can take >10 years to realize. As such, Merck & Co. has developed a systematic approach to evaluate adventitious agent risks associated with the use of animal derived raw materials in live virus vaccine manufacturing. This approach includes the combination of FMEA and the development of a novel raw material screening program to identify adventitious agent risks in animal derived raw materials. Potential strategies for remediating the identified adventitious agent risks are also presented.
Tara Tagmyer, Ph.D., Process Scientist, Vaccine Manufacturing Sciences & Commercialization, Merck & Co.
11:15
Overview of Regulations, Strategies and Methods Used to Minimize the Risk of Virus Contamination of Biopharmaceutical Processes and Products through Raw Materials
The risk of virus contamination through raw materials highly depends on the nature of raw material used in the production process of biopharmaceuticals. Different guidelines address different raw materials typically used in the production of vaccines, cell derived products and other human or animal derived products. These guidelines will be shortly outlined and summarized. Testing and physical or chemical treatment of raw material should provide significant virus safety. However, both testing and treatment provides safety to different degree. In this presentation the value and the limitations of testing methods and treatment procedures are discussed. Their impact must be considered adequately to define the total virus risk assessment of the biopharmaceutical product.
Horst Ruppach, Ph.D., Global Manager of Viral Clearance and Global Coordinator Virology, Charles River Biopharmaceutical Services, Germany
The risk of virus contamination through raw materials highly depends on the nature of raw material used in the production process of biopharmaceuticals. Different guidelines address different raw materials typically used in the production of vaccines, cell derived products and other human or animal derived products. These guidelines will be shortly outlined and summarized. Testing and physical or chemical treatment of raw material should provide significant virus safety. However, both testing and treatment provides safety to different degree. In this presentation the value and the limitations of testing methods and treatment procedures are discussed. Their impact must be considered adequately to define the total virus risk assessment of the biopharmaceutical product.
Horst Ruppach, Ph.D., Global Manager of Viral Clearance and Global Coordinator Virology, Charles River Biopharmaceutical Services, Germany
Panel Discussion
11:45
Raw Materials and Adventitious Agents
- Has the value/impact of raw material testing been measured?
- What new technologies and strategies are emerging?
- What are the current regulatory expectations and experiences?
- How to evaluate safety of raw materials from vendors?
Technology Workshop
12:15
This case study will show the relationship between manufacturing impacting the availability of various raw materials for biopharmaceutical companies, and the risk-mitigating steps we have encouraged our customers to take. This analysis is part of Doe & Ingalls' MOR™ (Management of Risk) program, in which we monitor the markets of key raw materials used in biotech production and make customers aware of market changes that can impact supply. A discussion of biopharmaceutical raw material variability, and associated issues, will also be included.
Charlotte Hicks, Management of Risk (MORTM ) Program Manager, Doe & Ingalls
12:45
Networking Luncheon in Exhibit & Poster Hall
1:55
Chairperson's Remarks
Karen Miller, Ph.D., Director, Product Attribute Sciences, Amgen, Inc.
Karen Miller, Ph.D., Director, Product Attribute Sciences, Amgen, Inc.
Raw Materials Management: Mitigation Initiatives and Control Strategies
2:00
Strategies for Addressing the Clearance of Raw Materials in Biopharmaceutical Products
Biopharmaceuticals are manufactured using a broad range of raw materials in cell culture/fermentation and in downstream unit operations. The removal of those raw materials with potential safety concerns must be addressed using the appropriate control strategy. Given the large number of raw materials used, it is important to develop the appropriate control strategies in order to mitigate the risks of the raw materials. The toxicity of the raw materials, the quantities used, and point of introduction in the process are important considerations as well as the product's stage of development, the dose, and route of administration. In this talk, tools for assessing the risks posed by residual raw materials and developing the appropriate control strategies will be discussed.
Karen Miller, Ph.D., Director, Product Attribute Sciences, Amgen, Inc.
Biopharmaceuticals are manufactured using a broad range of raw materials in cell culture/fermentation and in downstream unit operations. The removal of those raw materials with potential safety concerns must be addressed using the appropriate control strategy. Given the large number of raw materials used, it is important to develop the appropriate control strategies in order to mitigate the risks of the raw materials. The toxicity of the raw materials, the quantities used, and point of introduction in the process are important considerations as well as the product's stage of development, the dose, and route of administration. In this talk, tools for assessing the risks posed by residual raw materials and developing the appropriate control strategies will be discussed.
Karen Miller, Ph.D., Director, Product Attribute Sciences, Amgen, Inc.
2:30
UF Membrane Variability: Impact on Commercial Processes and Mitigation Strategies Ultrafiltration/diafiltration (UF/DF) is a unit operation ubiquitous to purification of polysaccharide-protein conjugate vaccine intermediates. This unit operation has historically exhibited significant sensitivity to known changes and inherent manufacturer variability in membrane or cassette characteristics and is a frequent source of risk to maintaining a robust manufacturing process. Therefore, significant experimental evaluation is typically required to understand, and in some cases mitigate, the impact of changes in ultrafilter characteristics as well as qualify alternate or replacement ultrafilters prior to implementation. In this presentation, a case study will be shared to illustrate process sensitivity to ultrafilter variability, and review key considerations for evaluating new (alternate or replacement) ultrafilters or vendor changes in existing components as illustrated through the development and application of lab- and pilot-scale models.
Samantha Davis, Technology Manager and Senior Process Engineer, Biomanufacturing Science Group, Pfizer Global Manufacturing Services
Samantha Davis, Technology Manager and Senior Process Engineer, Biomanufacturing Science Group, Pfizer Global Manufacturing Services
3:00
End-to-End Raw Materials Management in Vaccine Manufacturing Processes
This presentation will discuss the benefits of using value chain management (VCM) in vaccine manufacturing processes. We will discuss the impact of issues involving raw materials on upstream and downstream manufacturing steps, the effect of those issues along the whole value chain, and mitigation initiatives as part of VCM.
Humberto Vega Mercado, Ph.D., Technology Product Lead - Hep A Vaccine, Technology Operations, Merck & Co.
This presentation will discuss the benefits of using value chain management (VCM) in vaccine manufacturing processes. We will discuss the impact of issues involving raw materials on upstream and downstream manufacturing steps, the effect of those issues along the whole value chain, and mitigation initiatives as part of VCM.
Humberto Vega Mercado, Ph.D., Technology Product Lead - Hep A Vaccine, Technology Operations, Merck & Co.
3:30
Networking Refreshment Break and Last Chance for Exhibit & Poster Viewing
Evaluation and Quality Management of Supplier-Derived Raw Materials
4:00
Raw Material Evaluation and Qualification: Moving from Development into Commercial
Susan Lenk, Ph.D., Principal Scientist, PDMS API-Large Molecule, Janssen Pharmaceutical Companies of Johnson & Johnson
Susan Lenk, Ph.D., Principal Scientist, PDMS API-Large Molecule, Janssen Pharmaceutical Companies of Johnson & Johnson
4:30
Raw Material Qualification Process and Supplier Management: Phase I Through Commercial
Greg Page, Associate Director, Global Supplier Quality, Janssen Supply Group
Greg Page, Associate Director, Global Supplier Quality, Janssen Supply Group
5:00
Quality Management Best Practices in the Raw Material Supply Chain
It is critical to understand raw material suppliers' manufacturing capabilities and to monitor supplier performance, beginning in the early phases of product development. Alignment of material specifications and verification of assay results are critical to ensure an uninterrupted supply of raw materials throughout the lifetime of product. Key components of a robust supplier quality management program that enable this include supplier auditing, monitoring of changes, Quality Agreements and scorecard creation. Drug manufacturers should build collaborative relationships with their suppliers to allow for information sharing and timely resolution if issues do arise. Case studies and best practices in the supplier / drug manufacturer relationship will be explored during this discussion.
Kimberly Carnes, Manager, Quality Assurance Compliance, Human Genome Sciences, Inc.
It is critical to understand raw material suppliers' manufacturing capabilities and to monitor supplier performance, beginning in the early phases of product development. Alignment of material specifications and verification of assay results are critical to ensure an uninterrupted supply of raw materials throughout the lifetime of product. Key components of a robust supplier quality management program that enable this include supplier auditing, monitoring of changes, Quality Agreements and scorecard creation. Drug manufacturers should build collaborative relationships with their suppliers to allow for information sharing and timely resolution if issues do arise. Case studies and best practices in the supplier / drug manufacturer relationship will be explored during this discussion.
Kimberly Carnes, Manager, Quality Assurance Compliance, Human Genome Sciences, Inc.
5:30
Close of Conference
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