Scientific discovery and innovation have resulted in the successful introduction of various biological therapeutic modalities. However, drug product developers continually face new challenges that require changes to routine guidelines and manufacturing practices. While the drug product development process is well established for protein and peptide therapeutics, gene or cell therapy approaches face a greater level of stability challenges and unconventional GMP processes.

This presentation discusses how formulation development can be customized not only for conventional molecules like antibodies, but also for new biological modalities to address fundamental regulatory guidance. Examples of modality-dependent critical quality attributes and how those can be used to systemically build a good quality product are also covered.

• A 30-year personal journey through biologic drug development:
• Proteins to antibodies to gene therapy and vaccines

• Recurring themes, issues, and solutions

• The commercial importance of getting the formulation right


• Phase appropriate priorities and development process
• Key guiding principles

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