Navigating The CMC Regulatory Landscape During Protein Medicinal Product Development And Manufacturing

Developing and bringing protein-based medicinal products to market demands a robust and adaptable regulatory framework to guarantee their quality, safety, and effectiveness. This presentation offers an extensive look at the regulatory environment concerning Chemistry, Manufacturing, and Controls (CMC), highlighting key strategic considerations across the entire product lifecycle—from early preclinical stages through market authorization and ongoing commercialization.

The session details the organization of global regulatory submissions, including the Common Technical Document (CTD), and underscores the critical role of regulatory bodies such as the FDA and EMA in assessing both clinical and commercial applications.

We delve into recent regulatory advancements, such as accelerated development programs (e.g., FDA Breakthrough Therapy, EMA PRIME), emerging draft guidelines (e.g., FDA Platform Technology Designation), and updates to ICH guidelines (Q1, Q5C, M4Q). Using case studies and practical examples involving intricate drug substances and products like Antibody-Drug Conjugates (ADCs), the presentation demonstrates how Lonza assists clients in navigating these complexities through integrated regulatory services and strategic advice. The discussion emphasizes the significance of regulatory acumen, interdisciplinary teamwork, and flexibility for achieving success in today's ever-changing and increasingly complex global regulatory arena.

Learning Objectives:

• Gain an understanding of why a strategic, comprehensive approach to regulatory planning is crucial at every stage of protein medicinal product development to ensure timely and successful submissions.
• Learn to identify and apply evolving regulatory pathways and guidelines, recognizing that each submission and scenario is unique, and agency interpretations can differ, making the compilation of relevant data for each submission essential.
• Discover how partnering with experienced CDMOs can improve regulatory preparedness and support effective lifecycle management for biologic products.