CMC Regulatory Compliance of Biopharmaceuticals 2014

Key Topics

• How to Develop an Effective Corporate CMC Risk-Managed Regulatory Compliance Strategy for Biologics
  • Five (5) essential elements of an effective CMC strategy
  • The two major forces that shape the CMC regulatory compliance strategy of biologics
  • Necessity of a clinical phase-appropriate CMC regulatory compliance strategy
  • Impact of the strategic ICH guidances (Q8/Q9/Q10) on biologics
• CMC Regulatory Challenges for Biologics are Different
  • Comparison of the regulatory authorities (FDA, EMA/NCA) and regulatory review pathways (IND/IMPD, NDA/BLA, MAA centralized procedure) for biologics
  • Understanding the terminology landscape: biologic, specified biologic, biopharmaceutical, biosimilar
  • Biologics are not chemical drugs - four (4) unique CMC regulatory compliance challenges presented by biologics
  • The five (5) CMC regulatory compliance differences between the two U.S. pharmaceutical laws for biologics
• Challenge of Managing Manufacturing Process Changes and Demonstrating Biologic Product Comparability - Not an Easy Task
  • Demonstrating biologic product comparability - surprises happen!
  • Risk-based, sequential, clinical phase-appropriate comparability studies
  • Extreme CMC comparability - biosimilars - limitations of CMC biosimilarity
  • Difference between a FDA comparability study and a FDA comparability protocol
• Applying the CMC Regulatory Compliance Risk-Managed Strategy to Control of Biologic Manufacturing Processes
  • Need for clonality
  • Critical importance of biologic starting materials - four (4) myths about cell banks
  • Formulation and container-closure challenges for biologics - impact of components on biologic (e.g., aggregation) and impact of biologic on components (e.g., glass flaking)
  • Genetic stability, small-scale studies and clinical phase-appropriate control of the biologic manufacturing process
  • Illustration of Quality-by-Design (QTPP, CQAs, CPPs, risk-ranking) in selecting the control system for a biologic process

Who should Attend

Directors, Senior Management, Regulatory Affairs, Managers/ Supervisors QA/QC, Process Development personnel and Manufacturing interested or involved in the manufacture and control and CMC regulatory issues of biopharmaceuticals.