CMC Due Diligence for Accelerated Biologic Drug Development and Manufacturing

April 15, 2019
Joe Sheffer, Yanhuai (Richard) Ding, Kevin Zen, Alex Praseuth, Hemant Kumar, Peggy Marino

Volume 2019 eBook, Issue 1

Page Number: 4–11

The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.

With the biopharmaceutical business model undergoing rapid transformation as the result of disruptive new platform technologies and the need for accelerated biopharmaceutical development growing globally, clinical-stage therapeutic companies are facing complex challenges. A growing trend of partnerships between small biotech companies and CDMOs is also making it increasingly important to conduct CMC due diligence.

Read this article in BioPharm International's Outsourcing Resources 2019 eBook.

Article Details

BioPharm International
eBook: Outsourcing Resources 2019
April 2019
Pages: 4–11

Citation

When referring to this article, please cite it as Y. Ding et al., "CMC Due Diligence for Accelerated Biologic Drug Development and Manufacturing," BioPharm International's Outsourcing Resources eBook (April 2019).