CMC activities should be initiated by defining the right strategy at the beginning of development.
A thorough assessment of drug substance volumes, quality attributes, and the impact on toxicology and drug product, needs to be done early on. Similarly, the design of pre-formulation studies, analytical methods, dosage form selection, and development for toxicology and FIH studies should be considered in parallel with drug substance development. IND/IMPD filing can be achieved faster if all the CMC functions understand the phase-appropriate quality and regulatory guidelines.
In this webinar, you will learn:
- The importance of a rational, well-coordinated approach and a robust CMC strategy for achieving a timely start
- Incorporating phase-specific formulation and process design adjustments to mitigate risk at each stage
- How to leverage data of DCS, biopharmaceutical and DS properties to derisk and strategise FIH
- Evaluating the scalability of manufacturing processes and the potential regulatory impact of any changes in further clinical phases
- Tightening performance standards and minimizing variability in the final formulation in Phase III based on confidence achieved during earlier phases.
Meet the Speakers
Purushottam Singnurkar
Vice President – Formulation Development and Manufacturing
Syngene
Hrushikesava Reddy
Team lead – Research scientist in pharmaceutical development
Syngene
Deepak Mundhra
Independent Consultant
Inspire. Connect. Innovate.
