Regulatory Considerations for CMC & Assay Development of Live Biotherapeutics

Establishing an early-stage vision for bioprocessing developments of live biotherapeutic products from a datacentric perspective

• Understanding the optimum CMC and understanding assay appropriateness for specific live biotherapeutic formulas.
• Applying a targeted approach for CMC and assay development that reflects the regulatory landscape
• The importance of integrating technical expertise and regulatory understanding