Streamlining and Standardizing Process Characterization

Published on: 
BioPharm International, Partnerships for Outsourcing, May 2023 eBook, Volume 2023 eBook, Issue 2
Pages: 12–17

Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.

A biopharmaceutical or biotech innovator’s knowledge and understanding of a manufacturing process is gradually built during the activities that lead up to the product’s commercialization. FDA’s 2011 process validation guidance advises that a lifecycle approach should be taken as the product progresses through clinical trials and approaches potential commercial approval. This process incorporates three stages of process design, process qualification, and continued process verification. With each process designed and built using these three stages, knowledge accumulated will then inform the approach for subsequent product commercialization.

Read this article in BioPharm International's May 2023 Partnerships for Outsourcing eBook.


About the authors

Claudia Berdugo-Davis, PhD, is director of Process Development, Catalent Biologics, and Danielle Wittenwyler, PhD, is manager, Manufacturing Science & Technology, Catalent Biologics.

Article details

BioPharm International
eBook: Partnerships for Outsourcing
May 2023
Pages: 12–17


When referring to this article, please cite it as Berdugo-Davis, C.; Wittenwyler, D. Streamlining and Standardizing Process Characterization. BioPharm International’s Partnerships for Outsourcing eBook (May 2023).