Ensuring Quality in Contracted Support

Working with a contract development and manufacturing organization (CDMO) is a great way for smaller or diversified biotech companies, and even Big Pharma, to expand operations or modalities to reach the patients more efficiently. Outsourcing process development and manufacturing requires a lesser upfront investment with faster timelines while allowing teams at advanced therapy developers to focus on innovation. However, this relationship can deeply impact the quality and efficacy of a product. This article explores the balancing act of ensuring regulatory compliance via internal procedures at a CDMO and what to consider when starting
this relationship.

About the author

Iain McGhee is vice president of Quality at Ascend.

Article details

Pharmaceutical Technology: Bio/Pharma Outsourcing Innovation eBook
February 2024
Issue 2
Pages: 26-30

Citation

When referring to this article, please cite it as McGhee, I. Ensuring Quality in Contracted Support. Pharmaceutical Technology, Bio/Pharma Outsourcing Innovation eBook. February 2024.

Read this article in the Bio/Pharma Outsourcing Innovation February 2024 eBook.