How to Avert Disaster: (CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional™ Chemistry Certification

Just this week, biotech company DBV Technologies learned a harsh lesson in proper CMC protocol, as they were forced to withdraw their approval application of Viaskin Peanut, a peanut allergy treatment targeting children 4-11 years old. The FDA cited chemistry, manufacturing and controls issues as their reason for their rejection of DBV’s biologics license application, causing the company’s stock to drop a staggering 67.4%.

Even more disheartening, it appears that both the FDA and DBV believe the treatment is viable and effective. This potentially life-saving medication is now years behind its scheduled time-to-market because the proper CMC certification protocols were not in place, an avoidable error.

This lesson reminds those of us in the pharmaceutical and biotech space of the great importance of CMC certification for professionals developing and manufacturing drugs and biologics. At CfPIE, our Chemistry, Manufacturing & Controls (CMC) Certified Professional™ Chemistry Certification program is rigorous and taught by instructors with real-world knowledge of how to avoid CMC pitfalls and deliver high-quality results, on-time, with FDA-approval.

Better still, our CMC certification program is flexible, adapting both to your specific learning needs and your schedule. Students can choose from 14 course options to complete their 4-course requirement, and final exams are completed online to suit your schedule. 

To learn more about our CMC certification program, visit the program overview page, or browse our programs page for a full listing of certification courses we offer.
 

Source:

https://www.investors.com/news/technology/dbv-stock-peanut-allergy-treatment/