Iain McGhee is vice president of Quality at Ascend.

Iain McGhee

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.

Bio/Pharma Outsourcing Innovation February 2024 eBook

Pharmaceutical Technology: Bio/Pharma Outsourcing Innovation

 eBook
February 2024
Issue 2
Pages: 26-30

When referring to this article, please cite it as McGhee, I. Ensuring Quality in Contracted Support. 

Articles

This article looks at the relationship between a CDMO quality organization and the client.