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- Cell Culture and Upstream Processing
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- Introduction to Biopharmaceutical Manufacturing
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- Introduction to Downstream Processing in Biomanufacturing
- Analytical Method Development and Validation for Therapeutic Proteins
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August 20-21, 2013
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THE Industry Meeting Place to Exchange Real-World Solutions to Improve Speed, Cost and Quality
Conference: September 16-19, 2013 · Exhibition: September 17-19, 2013 ·
Pre-Conference Symposia Agenda
Pre-Conference Symposia Agenda
- Agenda overview: Go to the agenda overview to view the detailed agenda for each track or symposium.
- To view the complete agenda: Please download the PDF brochure.
Pre-Conference Symposia
Symposia: Monday Full-Day | Monday Half-Day | Courses | Main Conference: Tuesday | Wednesday | Thursday
8:00
Registration and Coffee
Symposium #1
Antibody-Drug Conjugates: Current Best Practice and Considerations for Processes and Facilities
9:00
Chairman's Opening Remarks
Leo Letendre, Ph.D., Research Fellow, Pfizer Inc
Leo Letendre, Ph.D., Research Fellow, Pfizer Inc
Featured Presentations
9:15
Process Development Strategies for Antibody-Drug Conjugates
Godfrey Amphlett, Ph.D., Vice President, Process and Analytical Development, ImmunoGen, Inc.
Godfrey Amphlett, Ph.D., Vice President, Process and Analytical Development, ImmunoGen, Inc.
10:00
Expectations for Microbiology Reviews of ADCs
Patricia Hughes, Ph.D., Team Leader, Biotech Manufacturing, DMPQ, CDER, US FDA (invited)
Patricia Hughes, Ph.D., Team Leader, Biotech Manufacturing, DMPQ, CDER, US FDA (invited)
Unpublished Data
10:30
Creating Next-Generation ADCs: Enabling Higher Capacity for Payloads and Stabilization of Interchain Cysteines by Biodegradable Polymer-Based Antibody Drug Conjugates
Peter Park, Ph.D., Vice President, Biology, Mersana Therapeutics, Inc.
Peter Park, Ph.D., Vice President, Biology, Mersana Therapeutics, Inc.
11:00
Networking Refreshment Break
11:15
Developing ADCs - Unique Differences from Traditional Therapeutics and Challenges in Process Development
Michael Sun, Ph.D., Director, Purification & Conjugation Development, Seattle Genetics, Inc.
Michael Sun, Ph.D., Director, Purification & Conjugation Development, Seattle Genetics, Inc.
Unpublished Data
11:45
Analytical Characterization of Early Stage Antibody Drug Conjugates at Amgen
Matthew A. Janson, Associate Scientist, Analytical R&D, Amgen
Matthew A. Janson, Associate Scientist, Analytical R&D, Amgen
12:15
Robust Methods to Analyze ADCs at Large Scale Manufacturing
Dorothee Lay, Ph.D., QC Manager Commercial Manufacturing ADCs, Lonza AG, Switzerland
Dorothee Lay, Ph.D., QC Manager Commercial Manufacturing ADCs, Lonza AG, Switzerland
12:45
Lunch on your own
2:00
Impact of 2011 FDA Process Validation Guidance on Process Development Strategy for Antibody Drug Conjugates
Leo Letendre, Ph.D., Research Fellow, Pfizer Inc.
Leo Letendre, Ph.D., Research Fellow, Pfizer Inc.
2:30
Assembling Teams to Manufacture ADCs: Realities vs. Expectations.
Deborah Meshulam, M.S., Director, Contract Manufacturing, ImmunoGen, Inc.
Deborah Meshulam, M.S., Director, Contract Manufacturing, ImmunoGen, Inc.
3:00
Afternoon Refreshment Break
Unpublished Data
3:30
Antibody-Drug Conjugates: Current Best Practice and Considerations for Processes, Facilities and Support Network
Vincent Turula, Ph.D., Director, Biotherapeutics Pharmaceutical Sciences, Pfizer Inc.
Vincent Turula, Ph.D., Director, Biotherapeutics Pharmaceutical Sciences, Pfizer Inc.
Unpublished Data
4:00
Case
Study
Formulation and Drug Product Development for Antibody Drug ConjugatesStudy
Gayathri Ratnaswamy, Ph.D., Associate Director, Analytical & Formulation Development, Agensys, Inc.
4:30
Audience Interactive Panel Discussion
5:00
Close of Symposium
Symposium #2
Bioassay Basics: Calculations and Components
9:00
Symposium Begins
Instructor: Laureen Little, Ph.D., Principal Consultant, Quality Services
Biological potency assays are loved for their broad specificity and ability to detect unexpected problems. However, they are also hated for inherent variability. Although the biological assay often saves entire development programs by preventing use of compromised therapeutic product during clinical trials, many sponsors seek to rid themselves of this assay. They claim it is too imprecise to be a useful QC release method. Yet few development teams spend sufficient time developing the biological components of their assay. This workshop focuses on describing the basics of a potency assay, how it differs from other routine release methods and focuses on how to improve the most critical and biological component of the biological assay; the development of the analytical cell bank.
Agenda to include:
- Overview of relative potency assay basics - how it differs from standard analytical methods
- Developing appropriate rationale for selection of the critical bioassay and its dependence on the biological component
- Basics of good tissue culture practice in a GMP facility
- Use of Quality by Design and DOE principles to select and optimize cell lines
- Developing a universal approach to optimizing different cell culture protocols
- Use of high-through-put Z factor analysis for optimizing cells
- Regulatory considerations of developing master and working analytical cell banks.
- Presentations from end users sharing case studies and lessons learned
About the Instructor:
Dr. Laureen Little has been actively consulting in the development, validation and maintenance of biological potency assays for regulated biotherapeutics for 25 years. She is a well-known trainer, produces various bioassay conferences in the US and EU, and actively works with start-up, midsize and large multinational firms developing and manufacturing a variety of products including vaccines, enzyme replacement products, gene therapy products, novel DNA/RNA products and many more. During this time she has worked with the gamut of biological components including animal systems, cultured cells, primary cells, blood components and purified proteins. Her practical approach, wide ranging experience and engaging instructional style makes this workshop a must attend and valuable session.
5:00
Close of Symposium
Symposium #3
Achieving Supply Chain Transparency and Continuity for Biopharmaceutical Raw Materials
9:00
Chairman's Opening Remarks
Scott Watson, Executive Director, AMPAC Fine Chemicals and Membership Chair, Rx-360: An International Pharmaceutical Supply Chain Consortium
Scott Watson, Executive Director, AMPAC Fine Chemicals and Membership Chair, Rx-360: An International Pharmaceutical Supply Chain Consortium
What Expectations Do Biopharmas Have of Their Suppliers?
Unpublished Data
9:15
Amgen's New Raw Material & Device Supply Chain Organization and Approach to Supply Chain Transparency
Patricia Turney, Executive Director, Raw Materials & Device Supply Chain, Amgen, Inc.
Patricia Turney, Executive Director, Raw Materials & Device Supply Chain, Amgen, Inc.
10:00
Genentech's Approach to Supply Chain Management
Lucy Cabral, Head, Supplier Quality Management and Distribution Quality Head, Genentech, Inc.
Lucy Cabral, Head, Supplier Quality Management and Distribution Quality Head, Genentech, Inc.
10:30
Networking Refreshment Break
11:00
Case
Study
What You Don't Know about Your Supply Chain May Be More Important Than What You Do Know: Case Study of a Buffer Component MaterialStudy
Patrick Rogers, Associate Director, Quality Assurance, Genzyme, A Sanofi Company
11:30
Achieving Supply Chain Transparency for Raw Materials
Robert Arnott, Senior Director, Global Supplier Quality, Baxter Healthcare
Robert Arnott, Senior Director, Global Supplier Quality, Baxter Healthcare
12:00
Finding the Common Road to Quality for Single Use Materials
Trishna Ray-Chaudhuri, Ph.D., Senior QC Associate II, Raw Materials/Pharm Tech Quality Biologics, Genentech, Inc., A Member of the Roche Group
Trishna Ray-Chaudhuri, Ph.D., Senior QC Associate II, Raw Materials/Pharm Tech Quality Biologics, Genentech, Inc., A Member of the Roche Group
12:30
Lunch on your own
How Raw Material Suppliers Ensure Supply Chain Integrity
1:45
A Supplier's Perspective of Supply Chain Transparency
As world events continue to challenge supply chain ties, SAFC is working with the industry to understand, share and clarify the opportunities and solutions for risk mitigation. As a critical supplier to the Biopharmaceutical market and trusted industry expert, Tom Beil will speak to the challenges of balancing cost and availability, while meeting customer expectations for no change, minimal risk, and supply chain transparency and security.
Tom Beil, Vice President, Quality and Regulatory Affairs, Sigma Aldrich/SAFC
As world events continue to challenge supply chain ties, SAFC is working with the industry to understand, share and clarify the opportunities and solutions for risk mitigation. As a critical supplier to the Biopharmaceutical market and trusted industry expert, Tom Beil will speak to the challenges of balancing cost and availability, while meeting customer expectations for no change, minimal risk, and supply chain transparency and security.
Tom Beil, Vice President, Quality and Regulatory Affairs, Sigma Aldrich/SAFC
Unpublished Data
2:15
Case
Study
Controlling Raw Material Variability and the Supply ChainStudy
Nandu Deorkar, Ph.D., Vice President, Research and Development, Avantor Performance Materials
2:45
More is Better: A Knowledge-based Approach to Supply Chain Transparency
The cornerstone of reducing risk to ensure the safety and security of cell culture media is transparency to your raw material supply chain. This talk will detail how one supplier of cell culture media and supplements achieves visibility of the supply chain through to the manufacturer and the manufacturing process which is a critical element of a robust supplier partnership.
James Carver, Director Quality & Compliance, BD Biosciences
The cornerstone of reducing risk to ensure the safety and security of cell culture media is transparency to your raw material supply chain. This talk will detail how one supplier of cell culture media and supplements achieves visibility of the supply chain through to the manufacturer and the manufacturing process which is a critical element of a robust supplier partnership.
James Carver, Director Quality & Compliance, BD Biosciences
3:15
Afternoon Refreshment Break
3:45
Vertical Collaboration Strategies to Reduce the Variability Introduced by Raw Materials and Improve the Robustness of Biopharmaceutical Manufacturing Operations
Vertical collaboration with suppliers is key to understand raw material quality attributes to improve the performance of biopharmaceutical manufacturing processes. This collaboration based on supplier transparency can be implemented to identify, track and control variability of raw materials. This presentation aims to describe the actions that support understanding of the supplier's process to ensure the utilization of appropriate raw material specifications that will improve the biopharmaceutical customer's production and final products.
Victor J. Melendez Colon, Ph.D., Principal Scientist, Process development, Amgen, Inc., Puerto Rico
Vertical collaboration with suppliers is key to understand raw material quality attributes to improve the performance of biopharmaceutical manufacturing processes. This collaboration based on supplier transparency can be implemented to identify, track and control variability of raw materials. This presentation aims to describe the actions that support understanding of the supplier's process to ensure the utilization of appropriate raw material specifications that will improve the biopharmaceutical customer's production and final products.
Victor J. Melendez Colon, Ph.D., Principal Scientist, Process development, Amgen, Inc., Puerto Rico
4:15
Audience Interactive Panel Discussion
Scott Watson, Executive Director, AMPAC Fine Chemicals and Membership Chair, Rx-360: An International Pharmaceutical Supply Chain Consortium
- What expectations do biopharmas have of their suppliers and what are suppliers doing to meet these expectations?
- Quality systems for preventing/detecting adulteration of raw materials
- Can suppliers be assured that working more closely with sponsors to provide greater transparency and data exchange will not be used against them?
- What is the benefit for a supplier to share more information?
Scott Watson, Executive Director, AMPAC Fine Chemicals and Membership Chair, Rx-360: An International Pharmaceutical Supply Chain Consortium
5:00
Close of Symposium
Symposia: Monday Full-Day | Monday Half-Day| Courses | Main Conference: Tuesday | Wednesday | Thursday
12:00
Registration and Coffee
Symposium #4
Knowledge and Data Management for Process Development and Manufacturing
Featured Presentation
1:00
Process Knowledge Management: Reducing Risk and Realizing Value from Development to Manufacturing
The bioprocess industry generates large amounts of unstructured data from process development that are difficult to exploit fully. The challenges are we speed up the development of robust processes by linking process development to manufacturing and providing a framework to share process information to all stakeholders; facilitate the transfer of processes to manufacturing assets; and manage process knowledge in a way that facilitates process understanding and continuous improvement. The lack of tools to perform these tasks is a major impediment to industry as there is no agreed framework for Product Lifecycle Management. There is an increasing awareness that to gain insights early on, to leverage and structure process information, taking advantage of QbD initiatives, a cradle to grave toolset is required. The potential is speeding development, reducing risk of failure, simplifies tech transfer and lead cost effective processes. The workshop will provide an overview and a perspective on the challenges they face, what they are seeking to achieve and what is the long term potential.
Andrew Sinclair, Managing Director, Biopharm Services Ltd.
The bioprocess industry generates large amounts of unstructured data from process development that are difficult to exploit fully. The challenges are we speed up the development of robust processes by linking process development to manufacturing and providing a framework to share process information to all stakeholders; facilitate the transfer of processes to manufacturing assets; and manage process knowledge in a way that facilitates process understanding and continuous improvement. The lack of tools to perform these tasks is a major impediment to industry as there is no agreed framework for Product Lifecycle Management. There is an increasing awareness that to gain insights early on, to leverage and structure process information, taking advantage of QbD initiatives, a cradle to grave toolset is required. The potential is speeding development, reducing risk of failure, simplifies tech transfer and lead cost effective processes. The workshop will provide an overview and a perspective on the challenges they face, what they are seeking to achieve and what is the long term potential.
Andrew Sinclair, Managing Director, Biopharm Services Ltd.
3:00
Refreshment Break
Unpublished Data
3:30
Case
Study
Development and Implementation of a Quality by Design (QbD) Based Control Strategy for Process and Product Knowledge Management throughout the Product LifecycleStudy
As part of a QbD based drug development, an initial process control strategy gets defined during early pre-clinical development based on a risk based criticality assessment of product attributes. As process and product knowledge is gained through the development phases, the criticality of process parameters and product attributes evolve and is reflected in the Process Control Strategy (PCS) along with risk assessments, thus providing a vehicle for knowledge management through the product development lifecycle. This presentation will provide specific details on how a PCS is to be developed and implemented. Lessons learned during implementation and best practices are discussed.
Kumar Dhanasekharan, Ph.D., Associate Director, Manufacturing Sciences and Technology, Genzyme, a Sanofi Company
Unpublished Data
4:00
Use of Multivariate Analysis to Turn Bioprocess Data into Knowledge
Pamela Sweeney, Ph.D., Senior Engineer II, Manufacturing, Technical Services, Shire HGT
Case
Study
Large quantities of data are collected during the course of manufacturing bioreactor operations, but it's difficult to relate this data to product quality attributes that are often not known for weeks afterward. In this case study, multivariate analysis tools are used to find relationships between bioreactor conditions and product quality attributes.Study
Pamela Sweeney, Ph.D., Senior Engineer II, Manufacturing, Technical Services, Shire HGT
4:30
Development and Implementation of a Biologics Control Strategy
The abstract for this talk was unavailable at press time.
Kenneth Green, Ph.D., Director, Technical Services, Pfizer Inc.
The abstract for this talk was unavailable at press time.
Kenneth Green, Ph.D., Director, Technical Services, Pfizer Inc.
5:00
Close of Symposium
Symposium #5
Product- and Process-Related Variants & Impurities
1:00
Mitigating Process Impurities during GMP Manufacture of Recombinant Influenza Vaccines Produced in the Baculovirus Expression System
The abstract for this talk was unavailable at press time.
Clifton E. McPherson, Ph.D., Vice President, Product Development, Protein Sciences Corporation
The abstract for this talk was unavailable at press time.
Clifton E. McPherson, Ph.D., Vice President, Product Development, Protein Sciences Corporation
Unpublished Data
2:00
Case
Study
Mitigating Risk of Color Variability for mAb TherapeuticsStudy
Formulated monoclonal antibody (mAb) products typically appear pale yellow in color at concentrations used for intravenous administration (10-20 mg/mL). With the recent trend toward high concentration mAb products (>100 mg/mL) for sub-cutaneous injection, variability in bulk drug substance (BDS) color has been reported. Color variability not only impacts placebo development and ability to blind clinical trials, but also suggests a lack of process control. For an IgG4 mAb produced at different sites and scales, several BDS lots were pale yellow as expected, while others exhibited red or yellow color of higher intensity when concentrated to >100 mg/mL. A cross-functional approach was taken to characterize and eliminate the color variability, and to identify a mechanism by which the color-causing component(s) could be bound to the product. A modified medium formulation was developed with several components at lower concentrations, resulting in less intense color in intermediate pools, and pale yellow BDS. With the original medium formulation, red-colored BDS was correlated to inter-chain disulfide reduction of the mAb prior to protein-A purification. These results suggest that for this product, the red color-causing component may be bound or coordinated to the mAb via thiol groups made available during certain processing steps. Since disulfide reduction can be prevented using published methods, this finding, along with the modified medium formulation, will enable color consistency for future BDS lots.
Gayle Derfus, Ph.D., Senior Research Scientist I, Biologics Development, Gilead Sciences
Unpublished Data
2:30
Case
Study
Raw Material Supply Chain Integrity: A Case Study of How Raw Materials Can Be a Trojan Horse for Process ImpuritiesStudy
A case study that illustrates that generic process controls can detect relatively small shifts in raw material purity. How understanding the full supply chain of your raw materials is key to ensuring proper GMP operations. Preventing introduction of Process Impurities is more complex than just incoming testing, it must also combine routine testing with supplier auditing, robust material specifications and scientific understanding of each raw material. How integral is your supply chain?
Amanda Ashcraft, Manager, Process Engineering/Development, Genzyme, a Sanofi Company
Patrick Rogers, Associate Director Quality Assurance, Genzyme, a Sanofi Company
3:00
Networking Refreshment Break
Unpublished Data
3:30
Case
Study
Implementing QbD Principles in Understanding and Controlling ImpuritiesStudy
The presence of both process-related and product-related impurities even in small amounts may influence the efficacy and safety of the pharmaceutical products. Therefore, impurity removal is one of the top priorities of purification process development. Implementing Quality by Design (QbD) principles in the purification process development will improve the process understanding and build a better control strategy to control the impurity clearance. In this presentation, the QbD principles that can be utilized in the purification process development and impurity clearance are discussed. A case study on how to utilize QbD principles to identify, understand, and control impurities are used to further explain the details.
Yiming Yang, Senior Scientist, Purification Process Development, Shire HGT
Unpublished Data
4:00
Case
Study
Advanced Process Control to Reduce Variability of Biological Product Quality at Biogen IdecStudy
The presentation provides an overview (past, present, and future) of the advanced process control initiative within Biogen Idec. The presentation will share a success story in applying advanced process control to reduce variability of a commercial biological process.
Lilong Huang, Ph.D., Senior Engineer III, Biogen Idec, Inc.
Unpublished Data
4:30
Case
Study
Identification and Characterization of Process Impurities in Therapeutic Replacement EnzymesStudy
The abstract for this talk was unavailable at press time.
Girija Krishnamurthy, Ph.D., Biologics Analytical Research and Development Leader, Shire HGT
5:00
Close of Symposium
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