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Event Information
Conference: September 20 - 24, 2010 · Exhibition: September 21-23, 2010 ·
Document Title
Product Lifecycle Management
Product Lifecycle Management
- 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.
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
7:00
Registration and Coffee
Product Lifecycle Management
Process Design: Establishing Design Space and Robust Process Parameters
8:00
Chairperson's Remarks
Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc.
Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc.
8:15
Case
Study
Developing an Appropriate Design Space Strategy to Mitigate Variability in Downstream Processing OperationsStudy
Lot to lot variability in chromatography adsorbent properties can result in unacceptable performance. The column operating conditions may need to be designed to be adsorbent lot specific to achieve acceptable performance. In this presentation, we discuss how a design space strategy can be used to mitigate such risks, by providing additional flexibility in applying the appropriate column operating conditions. Several case studies will be presented.
Justin McCue, Ph.D., Principal Engineer, Downstream Process Development, Biogen Idec
8:45
Multivariate Data Analyses and Real-time Multivariate Process Monitoring of Upstream Operations in Biopharmaceutical Manufacturing
Biopharmaceutical processes generate large amount of data in commercial operations that require advanced modeling and monitoring. Multivariate technology allows quickly identifying patterns in the process data to help facilitate process learning and troubleshooting. Examples from large-scale manufacturing applications in cell culture process monitoring approaches by using real-time process supervision will be demonstrated.
Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc./span>
Biopharmaceutical processes generate large amount of data in commercial operations that require advanced modeling and monitoring. Multivariate technology allows quickly identifying patterns in the process data to help facilitate process learning and troubleshooting. Examples from large-scale manufacturing applications in cell culture process monitoring approaches by using real-time process supervision will be demonstrated.
Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc./span>
9:15
Case
Study
Creating a QbD Chromatography Design Space Using Mechanistic Modeling TechniquesStudy
The FDA has called QbD "a good scientific approach" which involves "using good science" which "will result in cost benefits for the industry". This case study applies mechanistic modeling to identify critical parameters and define an ICH/FDA Q8 compliant QbD design space. Simulations were used to improve the separation, reduce operating costs and troubleshoot separation anomalies.
Peter K. Watler, Ph.D., Chief Technology Officer, Hyde Engineering + Consulting Inc.
9:45
Networking Refreshment Break
New, Unpublished Data
10:15
Case
Study
Use of DOE to Determine Process Parameters for a Robust Design Space in the Formulation of a Biopharmaceutical ProductStudy
Design of experiments (DOE) tools in product and process development can be confusing and frustrating, resulting in missed opportunities for increased knowledge about the product or process under consideration. This presentation will outline general DOE concepts for factorial and fractional factorial DOE's and describe a DOE used to optimize the formulation of a biopharmaceutical product.
Martin Kane, Associate Director Process Statistics, Department of Biostatistics, Human Genome Sciences, Inc.
10:45
What do you Need to Do to Fully Leverage Flexibility Inherent in QbD?
The overarching initiative of the FDA remains the "Drug Product Quality." It embraces many initiatives, one of which is Quality by Design (QbD). QbD is not a new concept. It has recently however, been formally introduced to our industry, in particular in terms of regulatory processes. Unless and until the regulatory, science, engineering and control issues are addressed then the desired regulatory flexibility will not be realized. This presentation will address possible means of gaining flexibility within the QbD framework.
Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.; former Senior Staff Fellow, OPS, CDER, US FDA
The overarching initiative of the FDA remains the "Drug Product Quality." It embraces many initiatives, one of which is Quality by Design (QbD). QbD is not a new concept. It has recently however, been formally introduced to our industry, in particular in terms of regulatory processes. Unless and until the regulatory, science, engineering and control issues are addressed then the desired regulatory flexibility will not be realized. This presentation will address possible means of gaining flexibility within the QbD framework.
Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.; former Senior Staff Fellow, OPS, CDER, US FDA
11:15
Audience Interactive Panel DiscussionLeveraging Flexibility in QbD
Moderator:
Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc.
Panelists:
Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.; former Senior Staff Fellow, OPS, CDER, US FDA
Martin Kane, Associate Director Process Statistics, Department of Biostatistics, Human Genome Sciences, Inc.
Justin McCue, Ph.D., Principal Engineer, Downstream Process Development, Biogen Idec
Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc.
Peter K. Watler, Ph.D., Chief Technology Officer, Hyde Engineering + Consulting Inc.
Moderator:
Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc.
Panelists:
Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.; former Senior Staff Fellow, OPS, CDER, US FDA
Martin Kane, Associate Director Process Statistics, Department of Biostatistics, Human Genome Sciences, Inc.
Justin McCue, Ph.D., Principal Engineer, Downstream Process Development, Biogen Idec
Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc.
Peter K. Watler, Ph.D., Chief Technology Officer, Hyde Engineering + Consulting Inc.
Luncheon Presentation
12:15
As the demands and challenges associated with the purification of therapeutic proteins increase, new tools are needed. In this talk, the development of three chromatography media to enable improved process flexibility in terms of plant fit and buffer requirements will be described. Efforts to develop a flexible three step monoclonal antibody purification involving minimal buffer changes/dilution between process steps will be discussed. Optimization of a process using Protein A affinity capture directly eluted onto a cation exchange column followed by elution and direct loading of an anion exchange membrane adsorber will be used to describe the process flexibility benefits of these new purification tools.
Richard Pearce, Program Director - Purification Solutions, Millipore Corporation
Product Lifecycle Management
Implementation and Execution
1:45
Chairperson's Remarks
Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc.
Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc.
New, Unpublished Data
2:00
Case
Study
Update on the Implementation of QbD at Genentech and Participation in the FDA QbD Pilot ProgramStudy
Genentech is piloting implementation of QbD with a monoclonal antibody that is in Phase III development. As part of that effort, Genentech was successful at getting the late stage product into the FDA QbD Pilot Program. This presentation will include an update on the strategy and approach being taken to implement QbD, and the lessons learned from the Pilot Program to date.
Vassia Tegoulia, Ph.D., Scientist, Pharma Technical Regulatory, Genentech, Inc.
2:30
Role of PAT in Operational Excellence
Operational excellence involves continuously improving a business, i.e., process and performance, enhancing quality, and minimizing waste. Process Analytical Technologies (PAT) may create a synergistic effect in the operational excellence strategies employed in the bio/pharmaceutical companies. PAT's role in the journey towards operational excellence in biopharma manufacturing environment will be discussed.
F. Ceylan Erzen, Senior Engineer, Industrial Engineering, Amgen Inc.
Operational excellence involves continuously improving a business, i.e., process and performance, enhancing quality, and minimizing waste. Process Analytical Technologies (PAT) may create a synergistic effect in the operational excellence strategies employed in the bio/pharmaceutical companies. PAT's role in the journey towards operational excellence in biopharma manufacturing environment will be discussed.
F. Ceylan Erzen, Senior Engineer, Industrial Engineering, Amgen Inc.
New, Unpublished Data
3:00
Case
Study
Development of Robust Process Parameters for the Production of a Therapeutic Glycoprotein Derived from Glyco-engineered Pichia PastorisStudy
In this case study, a robust manufacturing process was transferred to a CMO. In order to meet aggressive development time lines, design of experiments and ultra-scale down models were used to identify the design space for each unit operation. The presentation will also discuss some relationships of process parameters to identified critical product quality attributes.
Thomas Potgieter, Ph.D., Senior Investigator, Merck & Co
Co-authors: M. van Maanen; J. Pollard; R. Chmielowski; T. Linden
3:30
Networking Refreshment Break
Keynote Presentations
Chairperson: Curran Simpson, Senior Vice President, Operations, Human Genome Sciences, Inc.
4:00
Regulatory Modernization - FDA's Desired State for Product QualityThe Pharmaceutical Initiative of 2002 introduced the concept of improving the regulation of product quality throughout the pharmaceutical community. As a result, CDER initiated "quality by design" as a tool to assist industry in meeting higher product quality standards. Many innovator and generic firms have moved forward in implementing quality by design. This presentation will focus on the opportunities and challenges of implementing quality by design for biotech products.
Helen N. Winkle, Director, Office of Pharmaceutical Science, CDER, US FDA
4:45
The Role of Biosimilars in Driving Innovation in the Biopharmaceutical IndustryOver the past few years, biosimilars have emerged as an important new sector of the biopharmaceutical industry. The competitive nature of this new sector is encouraging innovation among leading biosimilar companies to bring differentiated and lower cost biologic products to patients. The introduction of biosimilar products is also likely to spur innovation from originator companies facing a more competitive marketplace. This presentation will explore the growing role of the biosimilars sector in driving innovation across the biopharmaceutical industry.
Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics R&D, Hospira, Inc.
5:30
Opening Night Reception in the Exhibit and Poster Hall
Sponsored by
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
7:00
Registration and Coffee
Product Lifecycle Management
Continuous Process Improvement
8:00
Co-Chairpersons' Remarks
Maninder Hora, Ph.D., Vice President, Product Operations, Facet Biotech
Ellen L. McCormick, Director, BioSciences Group, Pfizer, Inc.
Maninder Hora, Ph.D., Vice President, Product Operations, Facet Biotech
Ellen L. McCormick, Director, BioSciences Group, Pfizer, Inc.
New, Unpublished Data
8:15
Case
Study
A Continuously Evolving mAb ProcessStudy
Over the life cycle of a mAb, drivers such as supply demands, increased process knowledge, new technologies, regulatory standards and additions to manufacturing network all contribute in the decision to make process changes. This case study follows the strategy and challenges of a currently approved mAb purification process as it evolves from its original to its current and potential future state.
Debbie O'Connor, Scientist, Late Stage Purification, Process R&D, Genentech, Inc.
New, Unpublished Data
8:45
Case
Study
Continued Understanding of Biopharmaceutical Production Processes Post-ValidationStudy
Understanding of biopharmaceutical production process is a continuous task performed over the lifecycle of the product. Effective analysis of manufacturing data allows identification of trends and their potential root cause, as well as potential improvement opportunities within the design space. Procedures and case studies for effective process monitoring and identification and implementation of process and technology improvements will be presented.
Ciaran Brady, Ph.D., Associate Director, Biopharmaceutical Development, Human Genome Sciences Inc.
9:15
Humira Downstream Process: Challenges in Continuous Improvement and Technical Transfer
Humira (adalimumab) was successfully launched in 2002. Currently, it is manufactured at 6,000-L to 12,000-L scales in different facilities. In the past years, continuous efforts have been made to enhance process robustness, to ensure the consistency of product quality and process performance at different facilities, as well as to satisfy and harmonize divergent global regulatory demands. QbD approaches have been applied to the process optimization with implementing better process control strategies.
Helen Yang, Technical Operations, Abbott Bioresearch Center
Humira (adalimumab) was successfully launched in 2002. Currently, it is manufactured at 6,000-L to 12,000-L scales in different facilities. In the past years, continuous efforts have been made to enhance process robustness, to ensure the consistency of product quality and process performance at different facilities, as well as to satisfy and harmonize divergent global regulatory demands. QbD approaches have been applied to the process optimization with implementing better process control strategies.
Helen Yang, Technical Operations, Abbott Bioresearch Center
9:45
Networking Refreshment Break in Exhibit and Poster Hall
Sponsored by
New, Unpublished Data
10:30
Case
Study
Utilization of QbD Principles for the Management of Post-Approval ChangesStudy
Management of post-approval process changes for biotechnology products is well suited to the application of QbD principles and risk-based approaches. Here the application of QbD principles for the management of post-approval changes is applied to support drug substance changes intended to improve process efficiency, reduce raw material risks and support scale-up and process transfer.
Marc Better, Ph.D., Executive Director, Process Development, Amgen Inc.
New, Unpublished Data
11:00
Case
Study
Advanced Process Control and Real-Time Chromatography MonitoringStudy
Liquid chromatography plays an important role in the purification of pharmaceutical products derived from biotechnology processes. Process-scale separations often involve multiple column operations, each consisting of multiple phases so column packing, qualification and process monitoring are important areas of concern. This presentation discusses Biogen Idec's strategy for chromatography analysis and monitoring. This approach leverages the power of multivariate analysis, advanced analytical algorithms, and process knowledge to achieve the enhance process understanding and improved process performance.
Robert Genduso, Scientist II, Biogen Idec
New, Unpublished Data
11:30
Design of a Contamination Barrier for Serum-Containing Cell Culture Media of a Licensed Product
Despite their infrequency, microbial, viral and mycoplasma contaminations of biomanufacturing facilities have had significant financial, production and regulatory impacts to companies. Robustness of the contamination barrier depends on the degree of inactivation/clearance conferred by treatment technologies and the risk of raw materials. HTST, UVC, viral filtration and gamma irradiation, as well as raw material decomposition strategies, were evaluated to overcome impact to process/product.
R. Michael Boychyn, Ph.D., Principal Engineer, Amgen Colorado Process Development, Amgen Inc.
Despite their infrequency, microbial, viral and mycoplasma contaminations of biomanufacturing facilities have had significant financial, production and regulatory impacts to companies. Robustness of the contamination barrier depends on the degree of inactivation/clearance conferred by treatment technologies and the risk of raw materials. HTST, UVC, viral filtration and gamma irradiation, as well as raw material decomposition strategies, were evaluated to overcome impact to process/product.
R. Michael Boychyn, Ph.D., Principal Engineer, Amgen Colorado Process Development, Amgen Inc.
12:30
Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing
Poster presenters are requested to stand by their posters for discussion.
Poster presenters are requested to stand by their posters for discussion.
Plenary Session
3:30
Networking Refreshment Break in Exhibit and Poster Hall
Sponsored by
Keynote Presentations
Chairperson: Wolfgang Noe, Ph.D., Vice President, Bioprocess Development, Biogen Idec
4:00
Sustainable Commercial Cell Culture OperationsDeveloping a cell culture process which delivers a product with defined and acceptable critical quality attributes is but the first, and in many respects the easiest, element in the product lifecycle. Maintaining performance, ensuring the currency of the technical foundation and improving productivity and efficiency become the key challenges in having a sustainable operation. Knowledge is perishable; establishing routine can maintain performance but inhibit improvement; and everything ages. Hear about the systems that can be put in place to deal with these concepts across People, Process and Infrastructure.
W. Blair Okita, Ph.D., Senior Vice President, Manufacturing Sciences and Technical Operations, Genzyme Corporation
4:45
Finding a Home for Process and Product DevelopmentIn order to compete in today's cost-conscious world, the biotechnology industry needs to reinvent itself. Recognition of Manufacturing Technology and Product Development as a critical strategic element in this reinvention process and putting in place organizational design which enables their contributions are key to ultimate success. Process and product development are effectively carried out within the biotechnology industry under a number of different organizational designs (OD). The presentation will address, through example and guiding principles, where OD can enable game-changing outcomes.
S. Robert Adamson, Ph.D., Advance Biotech Consultants; former Senior Vice President Product and Process Development, Wyeth Biopharma
5:30
Networking Cocktail Reception in Exhibit and Poster Hall
Sponsored by
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