CMC Regulatory Compliance for Biopharmaceuticals and Biologics

This course is designed for those involved in developing or implementing, and those that need to understand the critical importance of, the Chemistry, Manufacturing & Controls (CMC) regulatory strategy for biopharmaceutical and biologic drug products. This includes Project Managers, Regulatory Affairs, Manufacturing, Quality Assurance, Quality Control and Process Development personnel.

Learning Objectives:

• Understand the importance and underlying principles for CMC regulatory compliance of biopharmaceuticals and biologics, and how this leads regulatory agencies to have different CMC regulatory requirements for biopharmaceuticals and biologics compared to pharmaceuticals of chemical origin
• Develop a cost-effective, risk-managed CMC regulatory compliance strategy to move these products through each stage of clinical development (from Phase 1 through Phase 3) and into commercialization, and how to maintain CMC regulatory compliance once market approval has been obtained
• Effectively communicate with regulatory authorities, both verbally and with written submissions, on significant biopharmaceutical and biologic CMC regulatory issues

Course Description:

With the rapid development and constantly changing Chemistry, Manufacturing & Controls (CMC) landscape of biopharmaceutical and biologic products and their manufacturing technologies, coupled with ongoing changes in compliance regulations, it is most important for a company to have an effective strategy to achieve CMC compliance.

At each stage of drug development, from Phase 1 through market approval, the basic question needs to be addressed: ‘What is absolutely necessary from a CMC perspective to be successful in getting our biopharmaceutical/biologic through the clinical trials and onto the market?’ CMC deficiencies have resulted in clinical holds and delays in market approval. Insights and practical suggestions to develop and manage CMC regulatory compliance for biopharmaceuticals and biologics are offered in this course.

This three day course will also present a strategy to obtain a cost-effective, risk-managed CMC regulatory compliance especially useful for all stages of clinical development and for those biopharmaceutical and biologic products already on the market.

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COURSE AGENDA

DAY ONE

CMC Challenges for Biopharmaceuticals/Biologics are Different

• Why biopharmaceuticals and biologics are treated differently than pharmaceuticals of chemical origin by the regulatory agencies
• The three unique CMC regulatory challenges for biopharmaceuticals and biologics
• Critical importance of CMC meetings with the FDA for biopharmaceuticals and biologics

Developing the Corporate CMC Regulatory Strategy for Biopharmaceuticals/Biologics

• Three key elements necessary for a complete CMC regulatory compliance strategy
• Managing the ‘minimum CMC continuum’
• GMPs cannot be ignored

DAY TWO

Effective CMC Strategy for Bio Manufacturing from Clinical Development Through Commercialization

• Source Material/Banks for biologics/biopharmaceuticals
• Expression/Production of the biologic/biopharmaceutical
• Purification of the biologic/biopharmaceutical
• Formulation and drug product manufacture

Managing Biopharmaceutical/Biologic Process Changes and Demonstrating Product Comparability

• Demonstrating product comparability – surprises do happen!
• Comparability protocols
• Post-market approval tiered process change requirements (PAS, CBE30, AR)
• Biologic Product Deviation Reports (BPDRs)

DAY THREE

Effective CMC Strategy for Bio Products from Clinical Development Through Commercialization

• Regulatory expectations for product characterization
• The art of setting a product specification
• Stability-indicating tests and how much change is acceptable

Critical CMC Submissions and Interactions with FDA

• How to avoid product approval delays of months and even years
• Pre-IND CMC briefing documents and the IND filing
• End of Phase 2 (EOP2) CMC briefing documents
• CMC sections for BLA/NDA, including the CTD format