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The WCBP CMC Strategy Forum Welcome to the WCBP CMC Strategy Forum We are pleased to welcome you to the WCBP CMC Strategy Forum. The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion. The meetings focus on relevant CMC issues throughout the lifecycle of a product and thereby foster collaborative technical and regulatory interactions. The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices. Outcomes of the Forum meetings are published in an appropriate peer-reviewed journal. Each meeting will focus on a CMC related issue such as product characterization, comparability, specifications, etc. The format of each meeting will consist of case studies and presentations by Industry and/or FDA experts to introduce the topic and the key issues of concern. Breakout sessions will then be conducted to allow for additional discussion on the technical and regulatory details of the topics. It is envisioned that the final outcome of the workshop discussions will be the development of a document to be submitted to the appropriate Regulatory Agency designees for their consideration in developing and/or clarifying good regulatory practice guidelines for biotechnology derived products. The success of the CMC Strategy Forum will depend on your active participation in discussing and raising issues pertaining to development of biologics. We encourage you to participate wholeheartedly in the workshops that have been designed to stimulate exchange of ideas and information. We would like to thank the speakers who are giving generously of their time and resources, and to you, for your attendance. We acknowledge the generosity of our program partners: AbbVie Inc., Amgen Inc., Biogen Idec, Biologics Consulting Group, Inc., Eli Lilly and Company, Genentech, a Member of the Roche Group, Janssen Pharmaceutical R&D, LLC, MedImmune, National Institute of Standards and Technology (NIST), Novo Nordisk A/S and Pfizer Inc. We are grateful for the expert management assistance of Karen Bertani and Stephanie Flores at CASSS. Their experience, guidance and skill in the preparation of this meeting have been invaluable. CMC STRATEGY FORUM ADVISORY COMMITTEE Siddharth Advant, ImClone Systems Corporation John Dougherty, Eli Lilly and Company Christopher Joneckis, CBER, FDA Rohin Mhatre, Biogen Idec Anthony Mire-Sluis, Amgen, Inc. Wassim Nashabeh, Genentech, a Member of the Roche Group Anthony Ridgway, Health Canada Nadine Ritter, Biologics Consulting Group, Inc. Mark Schenerman, MedImmune Keith Webber, CDER, FDA The Organizing Committee gratefully acknowledges the pharmaceutical and biotechnology industry for their generous support of the WCBP CMC Strategy Forum series: PROGRAM PARTNERS AbbVie Inc. Amgen Inc. Biogen Idec Biologics Consulting Group, Inc. Eli Lilly and Company Genentech, a Member of the Roche Group Janssen Pharmaceutical R & D, LLC MedImmune National Institute of Standards and Technology (NIST) Novo Nordisk A/S Pfizer, Inc. LEADING MEDIA PARTNERS BioProcess International International Pharmaceutical Quality MEDIA PARTNERS BioProcessing Journal LCGC North America Technology Networks Limited Forum Abstract Practical Use of Expanded Change Protocols Forum Co-Chairs: Rohin Mhatre, Biogen Idec Wassim Nashabeh, Genentech, a Member of the Roche Group Scientific Organizing Committee: Julia Edwards, Genentech, a Member of the Roche Group Chana Fuchs, CDER, FDA Rebekah Logan, Eli Lilly and Company Stefanie Pluschkell, Pfizer, Inc. Suzanne Stella, Biogen Idec Expanded change protocols (eCPs) were defined in the Office of Biotechnology Products’ Quality by Design (QbD) Pilot Program as a particular type of comparability protocol that will “describe the quality-by-design, risk-based approach linking attributes and processes to product performance safety, and efficacy.” A wide range of potential applications for eCPs has been explored by sponsors including movement within or beyond an established design space, site transfers, and additional process modifications supported by either a QbD or traditional regulatory submission. This Forum will evaluate this definition of eCPs from 2008 in light of case studies and examples that represent expanded change protocol concepts but may not fully realize the original vision. In addition to understanding what the “expanded” descriptor of an “e”CP really means, a list of potential eCP applications will be generated and the benefits, challenges, opportunities, and pitfalls to eCP strategies will be explored. Particularly, the relevance of eCP submissions to support global changes will be examined. For example, comparison of eCPs to Europe’s Post-approval Change Management Protocols (PACMP) will be made. The Forum will answer the following questions: • What is an expanded change protocol? • What type of changes should be considered for eCP? • What are the challenges and benefits of using eCP regulatory strategies? • How can we as an industry continue to evolve the eCP concept? WCBP CMC Strategy Forum Program Summary Practical Use of Expanded Change Protocols Monday, January 28, 2013 07:30 – 17:00 Registration in the Cabinet Room 07:30 – 08:30 Breakfast in the Promenade Foyer 08:30 – 08:45 CASSS Welcome and Introductory Comments in the Chinese Room Wassim Nashabeh, Genentech, a Member of the Roche Group WCBP CMC Strategy Forum Welcome and Introductory Comments in the Chinese Room Rohin Mhatre, Biogen Idec Putting the “e” in eCP: Definitions and Case Studies In the Chinese Room Session Chairs: Rebekah Logan, Eli Lilly and Company and Suzanne Stella, Biogen Idec 08:45 – 09:15 A Regulatory Perspective on Biotechnology Product Comparability Protocols: On the Continuum between Traditional and Enhanced Approaches Patrick Swann, CDER, FDA, Bethesda, MD USA 09:15 – 09:45 Retrofitting an eCP to an Existing Commercial Biotech Process Stephen Notarnicola, Biogen Idec, Cambridge, MA USA 09:45 – 10:15 Use of the eCP Concept for Post-approval Change Management Duane Bonam, Amgen Inc., South San Francisco, CA USA Toshi Mori-Bajwa, Amgen Inc., South San Francisco, CA USA 10:15 – 10:45 AM Break in the Promenade Foyer 10:45 – 12:15 PANEL DISCUSSION – Questions and Answers Sally Anliker, Eli Lilly and Company Duane Bonam, Amgen Inc. Toshi Mori-Bajwa, Amgen Inc. Stephen Notarnicola, Biogen Idec Patrick Swann, CDER, FDA 12:15 – 13:45 Hosted Lunch in the Colonial Room Monday, January 28 continued… Is the “e” Worth Our Time? Benefits and Challenges In the Chinese Room Session Chair: Stefanie Pluschkell, Pfizer, Inc. 13:45 – 14:15 Application of Enhanced Process and Product Knowledge to Facilitate the Lifecycle Management of a Biopharmaceutical Product Alan Gardner, GlaxoSmithKline, King of Prussia, PA USA 14:15 – 14:45 The Benefits and Challenges of Expanded Change Protocol Strategies Julia Edwards, Genentech, a Member of the Roche Group, South San Francisco, CA USA 14:45 – 15:15 PM Break in the Promenade Foyer 15:15 – 16:45 PANEL DISCUSSION – Questions and Answers Julia Edwards, Genentech, a Member of the Roche Group Chana Fuchs, CDER, FDA Alan Gardner, GlaxoSmithKline Anthony Ridgway, Health Canada 16:45 – 17:15 Recap of Program Summary Slide Presentation Nadine Ritter, Biologics Consulting Group, Inc. 17:15 – 17:25 Invitation to CMC Strategy Forum July 2013 18:00 – 19:30 Networking Reception in the Colonial Room Presenters Abstracts A Regulatory Perspective on Biotechnology Product Comparability Protocols: On the Continuum between Traditional and Enhanced Approaches Patrick Swann CDER, FDA, Bethesda, MD USA Protocols for manufacturing changes for biologics are described in the regulations (21 CFR 601.12(e)). In addition, FDA has published draft guidance (2003) specific for comparability protocols as applied to protein drug products. In the case of monoclonal antibodies, the number of traditional comparability protocols has been increasing along with the number of licensed products. The scope and nature of these protocols has evolved over time. In 2008, the Office of Biotechnology Products asked for volunteers to participate in a pilot program involving the submission of quality (chemistry, manufacturing, and controls) information for biotechnology products to gain more information and facilitate agency review of quality-by-design and risk-based approaches for manufacturing. The notice for the pilot program stated that Expanded Change Protocols will describe the quality-by-design; risk-based approach linking attributes and processes to product performance, safety, and efficacy. Lessons learned from review of pilot applications as well as other recent comparability protocols will be summarized. The presentation will focus on opportunities and pitfalls of comparability protocols. Opportunities include an emphasis on the importance of analytical procedures capable to discern relevant differences that may occur after a manufacturing change. Enhanced analytical capability can lead to enhanced product/process understanding which can create the basis for more flexible regulatory approaches. NOTES: Retrofitting an eCP to an Existing Commercial Biotech Process Stephen Notarnicola Biogen Idec, Cambridge, MA USA After approval and throughout the lifecycle of a product, a Company’s knowledge and understanding of their product and process continually expands. To leverage this knowledge and provide continuous improvement opportunities to an existing commercial monoclonal antibody process, the company proposes to apply select aspects of current regulatory and quality
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