CMC Due Diligence for Accelerated Biologic Drug Development and Manufacturing
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).
Novel Modalities Spur Shift in Outsourcing Processes and Partnerships
May 8th 2025While a one-stop shop still has its advantages, sponsor companies and CDMOs are starting to see each other not as transactional relationships, but true partners with a common goal of getting drugs to patients faster.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
