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).
VERAXA and Voyager to Create Combined Business for Advancing Pipeline of Next-Gen Cancer Therapies
April 23rd 2025The proposed business combination would create a publicly traded, clinical-stage biopharmaceutical company that will focus on developing a pipeline of next-generation cancer therapies.
Tokyo University of Science Research Team Explores Improved Delivery of Antisense Oligonucleotides
April 18th 2025Using cholesterol-modified oligonucleotides, the research team aims to improve the delivery of antisense nucleotide-based therapies for treating neurodegenerative diseases and brain cancers.
Thermo Fisher Opens Advanced Therapies Collaboration Center in California
April 18th 2025The 6000-square-foot facility will provide cell therapy developers the support they need to transition to CGMP manufacturing, and an expanded footprint of the new center is expected to open in Philadelphia later in 2025.
