Ensuring Quality in Contracted Support

Science team, tablet and analysis study in lab for pharmaceutical collaboration, scientist teamwork and working on research. Medical analysis, laboratory innovation and pharamacy partnership on device. | Image credit: ©J Bettencourt/peopleimages.com - stock.adobe.com

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.