Selecting the Right CMC Strategy for Biologics

Published on: 
BioPharm International, BioPharm International, Regulatory Sourcebook October 2021, Volume 2021 eBook, Issue 4
Pages: 18–21

Smaller biopharma companies must do due diligence with their CMC strategy for BLA filings.

Advancing a novel biologic from bench to patient bedside is a complex and arduous process. The chemistry, manufacturing, and control (CMC) strategy that a biomanufacturer employs is as critical to the filing of an investigational new drug application or biologics license application as conducting clinical trials. Because there is no one-size-fits-all approach to CMC, the strategy is often tailored to each compound’s specific platform and method of delivery. This is especially true for biologics because each one is unique to the indication and often involves a shortened development timeline.

Read this article in BioPharm International’s October 2021 Regulatory Sourcebook eBook.


About the author

Khanh Ngo Courtney, PhD, is senior director of Biologics, Avomeen.

Article Details

BioPharm International
eBook: Regulatory Sourcebook, October 2021
October 2021
Pages: 18–21


When referring to this article, please cite it as K.N. Courtney, “Selecting the Right CMC Strategy for Biologics," BioPharm International Regulatory Sourcebook eBook (October 2021).