Process Validation for Biopharmaceuticals
Event Information
Document Title
Agenda
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Day One Monday, March 2, 2009 | DAY ONE | DAY TWO | | ||||
| 7:00 | Registration and Coffee | |||
| 8:40 | Chairperson's Announcements & Introductory Discussion The approach to process validation has evolved with the maturation of the biopharmaceutical industry and changes in the expectations of regulators. Conference sessions will provide an overview of the changes and will highlight how process validation fits into the product lifecycle, use of risk-based approaches, application of platform knowledge, experimental design and data analysis approaches, and the impact of QbD on process validation. The FDA's Quality by Design (QbD) initiative including the new biologics pilot program requires that manufacturers be able to demonstrate a high degree of process understanding and control and as such may gain from more flexible regulatory oversight. Ron Taticek, Ph.D., Director, CMC Regulatory Affairs, Genentech, Inc. | |||
| Assessing the Most Effective Approaches to Process Validation | ||||
| 9:00 | Connecting Process Characterization with Process Validation Abstract to come. Amos M. Tsai, Ph.D., Principal Scientist, Process Development, Amgen, Inc. (Invited) | |||
| 9:30 | Examining the Process Validation Lifecycle: Phase III through Commercial This presentation addresses the key factors which should be considered when approaching this pivotal stage of the process validation project. Included will be strategic plans for managing process validation while implementing process changes during Phase III, scaling-up for commercialization and comparability studies. Specific examples of cell culture, purification, formulation and fill process validation issues will be provided. EJ Brandreth, Vice President, Quality and Regulatory Affairs, Althea Technologies, Inc. | |||
| 10:15 | Networking Refreshment Break in Exhibit Hall with Poster Viewing | |||
| 11:00 | Risk-Based Process Validation: Satisfying the FDA and ICH Q8-Q10 Companies are continually spending time and resources to perform traditional process validation activities to meet perceived inspection needs. The FDA is now asking for an innovative approach to speed up pharmaceutical product development and licensure. With the introduction of the FDA initiative for risk-based approach, and ICH Q8-Q10, we are entering a new era of process validation. This presentation will show new approaches that meet current regulatory expectations and show how risk assessment can be tied to process characterization and validation, as well as explain how the utilization of ICH will save time and money. Hamid Mollah, Ph.D., Senior Technical Manager, Corporate Quality, Validation, Genentech, Inc | |||
| 11:30 | Matrix/Family Grouping Approaches to Process Validation Abstract to come. David Lee, Ph.D., Senior Validation Engineer, Amgen, Inc. | |||
| 12:00 | Technology Workshop IBC's Technology Workshops offer supplier companies the opportunity to present product or service offerings directly to the audience at this conference. For more info on presenting please contact Kristen Schott at 508-614-1239 or kschott@ibcusa.com. | |||
| 12:30 | Networking Luncheon in Exhibit Hall with Poster Viewing | |||
| 1:55 | Chairperson's Remarks Rajiv Nayar, Ph.D., President, HTD Biosystems Inc. | |||
| Designing Effective Experiments in the New Era of Process Validation | ||||
| 2:00 | Analysis of Validation Data Understanding the nuances of design of experiments (DOE) analysis in assay validation can be confusing and frustrating, resulting in missed opportunities for increased knowledge about the process under consideration. This presentation will outline the general concepts for factorial DOE analysis, and provide a framework for both well behaved and messy data, thus leading to increased knowledge, increased customer satisfaction, and increased throughput. Martin Kane, Associate Director, Process Statistics, Human Genome Sciences, Inc. | |||
| 2:30 | Assessing/Understanding Raw Data to Improve Validation Activities Scale-down data from the fermentation and purification processes were evaluated to ensure successful validation lots at the production scale. Assessment of the raw data includes understanding scaleable and non-scaleable factors, interpreting discrepancies, and defining the window of operation. Success of this assessment strategy was confirmed by observations at the production scale predicted by the scale-down model. Catherine Kha, Associate Scientist, Research & Development, Lonza Biologics Inc. | |||
| 3:00 | Networking Refreshment Break in Exhibit Hall with Poster Viewing | |||
| 3:45 |
Design of Experiment (DOE) offers a robust tool that can evaluate multiple variables in a single experimental design set. The empirical process landscape from the DOE analysis ranks the order of importance. The interactions between the variables provides a predictive model for the manufacturing process. This presentation will discuss the advantages and disadvantages of using DOE in process optimization studies and its use in identifying the critical process variables that need to be validated. Examples in the use of statistically designed multivariate experimental designs in manufacturing processes will be demonstrated using specific examples. Rajiv Nayar, Ph.D., President, HTD Biosystems Inc. | |||
| 4:30 |
Once acceptable critical quality attributes have been established, process characterization studies can be used to define the acceptable range of process parameters. These acceptable ranges are usually the settings that get carried over for process validation. This talk will expose the audience to statistical techniques such as stepwise regression that can be used to model the DOE results, even when the design is not a typical response surface model. A case study will be presented that shows how the actual settings can be used to model the effects to prioritize the parameters in the design space. Thomas Harrington, Associate Director, Research & Development, Lonza Biologics Inc. Steven Walfish, President, Statistical Outsourcing Services | |||
| Featured Presentation | ||||
| 5:00 | Continuous Improvement in the Low Cost Manufacturing of Bovine Somatotropin Manufacturing Posilac® at very low cost necessitates an extreme focus on process research and implementation of improvements throughout the lifecycle of the product. For your review and examination, our approach and perspectives on process efficiency and process change for the production of bovine somatotropin for the dairy industry will be presented, highlighting implemented tactics that saved time, money and satisfied the FDA. Brad Storrs, Ph.D., Senior Fellow and Bioprocess Technology Lead, Monsanto Company | |||
| 5:30 | Networking Cocktail Reception in Exhibit Hall with Poster Viewing | |||
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Day Two Tuesday, March 3, 2009 | DAY ONE | DAY TWO | | ||||
| 7:30 | Registration and Coffee | |||
| 8:45 | Chairperson's Announcements Amit Banerjee, Ph.D, Research Fellow, Global Biologics, Pfizer Inc. | |||
| Advantages, Challenges and Obstacles of Quality by Design Implementation | ||||
| 9:00 | Better, Faster, and in Control: Regulatory Remediation in Process Validation Process Analytical Technology (PAT), is characterized by continuous and cybernetic monitoring; the use of design space to establish flexible parameters of performance; effective risk assessment to mitigate validation approaches. The opportunity to prepare for a Quality Systems Inspection with an independent pre-inspection audit provides pharmaceutical companies with opportunities to improve the regulatory process, speed approvals and maintain control during regulatory review. This presentation will identify the methodologies and provide the guidelines for effective better, faster, in-control regulatory remediation. Sandy Weinberg, Ph.D., Associate Professor of Health Care, Clayton State University, Senior Consultant, Tunnell Consulting, Inc. | |||
| 9:30 | An Effective Approach for the Creation of Design Space Defining a design space for bioprocesses is an essential component of the Quality by Design approach to product development. Pfizer has developed a comprehensive "Right First Time" approach for developing and managing products throughout their lifecycle; a component of this process provides a structured approach for assessing risk and determining functional relationship between process parameters and quality attributes. This presentation will focus on implementation of such an approach for a biologic compound, with the view of defining the design space for process steps. Amit Banerjee, Ph.D, Research Fellow, Global Biologics, Pfizer Inc. | |||
| 10:15 | Networking Refreshment Break in Exhibit Hall with Poster Viewing | |||
| 11:00 | Expanded Change Protocols and the Impact on Process Validation For the biologics pilot program, the FDA has requested that information regarding process understanding and control be presented in an Expanded Change Protocol (ECP). Comparability protocols have been used to outline a specific manufacturing change and describe the testing and acceptance criteria to ensure those changes will not have an adverse effect on the identity, quality, strength, quality, purity and potency of the product. The ECP should be used to describe the QbD approaches, critical quality attributes and link those attributes to process parameters and ultimately safety and efficacy of the product. This presentation will look at some examples of how the ECP could be applied to manufacturing changes and the impact to the process validation. Laurie Kelliher, Director, CMC Regulatory Affairs, MedImmune, Inc. | |||
| 11:30 | Applying Lean Six Sigma Approaches to QbD Abstract to come. James Sandler, Senior Quality Engineer, Nektar Therapeutics, Inc. | |||
| 12:00 | Technology Workshop IBC's Technology Workshops offer supplier companies the opportunity to present product or service offerings directly to the audience at this conference. For more info on presenting please contact Kristen Schott at 508-614-1239 or kschott@ibcusa.com | |||
| 12:30 | Networking Luncheon in Exhibit Hall with Poster Viewing | |||
| Keynote Presentation | ||||
| 1:45 | Critical Quality Attributes: The Foundation of QbD and Process Validation In a Quality by Design (QbD) approach, the acceptable ranges claimed in a license (Design Space) are linked directly to the acceptable ranges for Critical Quality Attributes (CQAs), and by definition, to acceptable product safety and efficacy. This presentation will discuss an approach for the identification of CQAs and how CQAs may be integrated into process validation over the product lifecycle. Ron Taticek, Ph.D., Director, CMC Regulatory Affairs, Genentech, Inc. | |||
| Audience Interactive Panel Discussion | ||||
| 2:30 | How Will a QbD Filing Impact Process Development? This Audience Interactive Panel Discussion will offer varying thoughts and opinions regarding the key actions and directions that are needed to develop the process knowledge to deliver a QbD submission. Chairperson and Moderator: Amit Banerjee, Ph.D, Research Fellow, Global Biologics, Pfizer Inc. Panelists: Ron Taticek, Ph.D., Director, CMC Regulatory Affairs, Genentech, Inc. Sandy Weinberg, Ph.D., Senior Consultant, Tunnell Consulting, Inc. Laurie Kelliher, Director, CMC Regulatory Affairs, MedImmune, Inc. | |||
| 3:00 | Networking Refreshment Break in Exhibit Hall with Poster Viewing | |||
| New and Emerging Process Validation Challenges | ||||
| 3:30 | Validating Single Use Products Abstract to come. Mike Su, Ph.D., Technology Specialist, Bayer HealthCare | |||
| 4:00 | Use of Scale-Down Models in Process Validation Risk-based as well as traditional approaches to process validation require the generation of large amounts of data. Frequently this data is produced at process extremes that would not normally be run at scale. Most often, the solution is use of a scale-down process model. Deepen your understanding of the small scale model, including its utility and limitations in the increasingly important overall validation strategy. Debbie Weigl, Senior Consultant, Tunnell Consulting, Inc. | |||
| 4:30 | IP Protection for Next Generation Products Intellectual property (IP) protection, particularly patent protection of validated processes had been an essential component for the commercialization of innovative biotech and pharma products. What will the new role of process validation IP be in a world of follow-on biologics and how will next generation products be affected? Opportunities for obtaining and maintaining patent protection in a challenging U.S. market and a growing global market will be discussed. Janet McNicolas, Ph.D., Partner, Bell Boyd and Lloyd, LLP | |||
| 5:00 | Close of Conference | |||
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