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Road Map for Drug Product Development and Manufacturing of Biologics

29 February 2024

Therapeutic biologics products encompass different modalities, and their manufacturing processes may be vastly different. However, there are many similarities that run across the different modalities during the drug product development and manufacturing. In this talk, we will review a roadmap in a phase dependent manner delineating formulation, drug product development and manufacturing considerations in alignment with the different phases of clinical development from pre-clinical through commercialization.

- Mathew Cherian PhD, VP of Operations & Development ReVive Biotechnolohy, United States

- Nikolina Biskic, Regulatory Affairs Manager, Switzerland

- Krishnan Sampath, Senior Vice President of CMC Development and Manufacturing, USA