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Selecting the Right CMC Strategy for Biologics
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Selecting the Right CMC Strategy for Biologics
Publication
Article
BioPharm InternationalBioPharm 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.
peshkova/Stock.adobe.com
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
Citation
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).
Articles in this issue
Industry Organizations Assist Pharma During the Pandemic and Beyond
NIST Proposes Clarifications to Bayh-Dole March-in Rights Regulations
How Artificial Intelligence Impacts the Global Regulatory Environment
Selecting the Right CMC Strategy for Biologics
The Evolving Biosimilar Approach
Serialization and Aggregation from a Manufacturing Perspective
The Real Danger of Substandard and Counterfeit COVID-19 Vaccines
Collecting Industry’s Thoughts on FDA FARS Report
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