ISPE Biopharmaceutical Baseline Guide Presented by: Jeff Biskup, CRB At Omaha, Nebraska April 14, 2005
Biopharm Baseline Guide Presentation Overview � Jeff Biskup, CRB – Background, Intro/Overview and Process Utilities � Mark VonStwolinski, CRB – Facilities Issues � Pat Hamell, Pfizer – Process Equipment & Manufacturing Issues and Real Life Applications
First Some Background
Biopharmaceutical Industry Evolution � Biopharmaceutical Industry is Evolving – Transitioning from » R&D focus to commercial manufacturing » Small entrepreneurial companies becoming big businesses � Biopharmaceutical Baseline Guide will significantly impact industry.
Where has it Been? � Primarily in R&D, most recently heavy in Development � Mostly technology based entrepreneurial operations � Mostly located in R&D centers � Staffing predominantly PhD’s and highly creative developers
Where is it Now? � Transitioning to commercial production for blockbusters – Learning how to produce GMP products – Moving to industrial regions � Building MEGA plants for large scale production � Building clinical production operations � Matching up business partners � Recognizing the importance of being in manufacturing regions
Where is it Going? � There will be: – More companies manufacturing GMP biotech product & many larger companies – Multi-product producers with many small products � Companies will need to learn to produce cost competitive products for smaller patient markets
Some Key Challenges Resulting from the Evolution � Needed Resources: – Efficient production facilities » Few licensed facilities – Experienced workers » Development » Construction » Production » Support services
Some Key Challenges Resulting from the Evolution � What is wrong with existing biotech staff? – Not enough of them – Few are experienced in large scale GMP production
Some Key Challenges Resulting from the Evolution � Challenges converting existing pharma company staff for biotech – Processes significantly different » More vulnerable to bioburden issues » Not accustomed to processing conditions conducive to developing biological contamination » New or evolving product lines and processes pose challenges
And then came the Biopharmaceutical Baseline Guide How will the Biopharmaceutical Baseline Guide help to resolve these challenges?
As a Training Tool � The Guide provides fundamental information regarding bioprocess operations – Describes general principles of bioprocess operations – Identifies process operations where product is vulnerable – Highlights differences with conventional pharmaceutical operations
Helping Harmonize Pharmaceutical Regulators Worldwide � ISPE Baseline Guides focus on fundamental principles of GMP – What is critical to producing quality products consistently and reliably? � Fundamentals help unify regulators and minimize focus on special/regional interests
Providing Background for Evolving Manufacturing Operations � Guide presents substantial information relative to: – Multi-product manufacturing » Cleaning operations » Product segregation strategies – Various production scales
The Guide And Now
Goals & Objectives of the Biopharmaceutical Baseline Guide � Balance capital, risk, and operating cost � Get CBER, CDER and field buy-in – Understand Team Biologics � Consistency in best practices � Clarify and document common industry issues � Reduce ambiguity in requirements � Address multi-product manufacture � Reduce start-up and qualification efforts � Baseline of critical regulatory issues, not a textbook
AND to Promote the BASELINE Philosophy � Focus investment on facility issues that effect our goal to produce quality pharmaceutical products and devices reliably and consistently . � Avoid unnecessary spending on facility features that do not contribute to that goal.
The Steering Team � Team � Co-Chairmen – Geoff Attenborough - Amgen – Richard Priester – Gary Bird - Lilly – Mel Crichton – Jeff Biskup - CRB – Jan Gustafsson - Novo – Ken Jacobson - CRB � FDA – Tom Keuer - Baxter – Steve Miller – Wyeth Biopharma – Kip Priesmeyer – Noshir Mistry – BristolMyers Squibb – Mark vonStwolinski – Dowler Gruman – Jeff Sarvis – Fluor – Patricia Turney - Amgen – John Ward – Biogen – Depak Agarwal – Jacobs – Jeff Odum – CRB
Additional Participants in the Biopharmaceutical Baseline Guide � Steering Committee = Writers – Industry + Engineers + FDA contact � Chapter Teams = primary review � Industry review: – Focus Groups – Presentations – Industry Reviewers � FDA Reviewers – Content locked in after FDA comment
Industry Reviewers � Over 100 people – Discussion Team – Writers – Reviewers � Representation – Pharma – Biotech – Engineering Consultants – Contract Manufacturers – Equipment Manufacturers
FDA Reviewers Supporting Kip Tom Arista - National Expert, Team Biologics - Dallas � Janice Brown - CBER reviewer (licensing) - Rockville � Mark Brunswick, PhD - CBER Reviewer (prod spec) - Bethesda � Earl Dye PhD - CBER Reviewer (prod spec) - Bethesda � Jay Eltermann - CBER � John Finkbohner PhD - CBER reviewer (licensing) - Rockville � Rick Friedman - CDER Office of Compliance - Rockville � Jim Giefer - Drug Specialist - St Louis � Dennis Guilfoyle, Ph.D. - regional micro lab � Mariza Jafary - Team Biologics - Los Angeles � Kevin Kallander - Sterility Specialist - Denver � Steve Kilker - Investigator - Cincinnati � Joe McGinnis, Drug Specialist, North Brunswick, NJ to the FDA � Rick Thornton - Team Biologics - Buffalo �
Chapters of the Biopharmaceutical Guide 1: Introduction 2: Concepts & Regulatory Philosophy 3: Manufacturing Activities / Operations 4: Process & Equipment Considerations 5: Process Support 6: Facility Integration 7: Process Controls & Automation 8: Commissioning & Qualification 9: Glossary 10: (Appendix) European Aspects
Chapters 1 & 2 Introduction & Regulatory Concepts � Provides broad introduction to Guide and perspective on Regulatory Concepts – Principles of Product Protection – Controlled bioburden processing versus aseptic processing – Open versus closed processing – Multi-product issues
Chapters 1 & 2 Introduction & Regulatory Concepts � Introduce concepts like – Segregation – Biohazard containment – Cleanability – Area cleanliness classification
Chapter 3 Manufacturing Operations � Procedural and Operational Controls – Open vs. closed process � Bioburden-controlled processing � Viral clearance/inactivation � Segregation methods � Multiple product operations � CT materials manufacture
Chapter 4 Process and Equipment � Organization – PFDs for Typical Biopharmaceutical Processes – Critical Process Parameters – General Considerations for Equipment Design – Specific Equipment Design Considerations
Chapter 4 Process and Equipment � General Considerations – Integration of equipment design with facility – Process Closure – Materials on Construction – Biohazards – Cleaning – Modular Equipment
Chapter 4 Process and Equipment � Specific Equipment Design Considerations – Raw Material Storage/Handling/Dispensing – Media/Buffer/Component Prep/Hold – Inoculum Prep – Fermentation/Cell Culture – Recovery/Harvest – Purification
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