Chemistry, Manufacturing & Controls (CMC): Regulatory Compliance for Biopharma Professionals

An integral step in the drug development process, Chemistry, Manufacturing & Controls (CMC) is the link that takes a promising compound and makes it a replicable reliable product that can effectively treat patients. For pharmaceutical professionals who concentrate in this area, the rewards can be huge: CMC has the greatest impact on patient safety. Additionally, creating an effective dosage protocol, not to mention deciding how the treatment should be administered, ultimately decides whether the public accepts the pharmaceutical as a significant breakthrough that they are willing to buy.

Our course CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars focuses on this rapid-innovation sector, and prepares biopharmaceutical professionals for tomorrow’s problems, today. Taught by instructors with real-world experience, this three-day intensive prepares you for effective decision-making in the development of your regulatory compliance strategy.

Biopharmaceuticals represent a significant CMC challenge for manufacturers in scaling the NCE or prototype to mass production. With less than 1% of all drug development experiments eventually making it to market, the potential for failure in the CMC pipeline is high. Our CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars course ensures that as a CMC professional, you can not only put the regulatory controls in place for FDA acceptance, but also ensure the highest quality, efficient timelines, and most importantly, anticipate any pitfalls along the way.

Recently, the importance of CMC was highlighted by the Bill and Melinda Gates Foundation. Cortellis CMC Intelligence was launched on October 15 of this year, partly supported by a grant from the Gates’ foundation, in order to aid development of drugs, vaccines and diagnostics needed most in low and middle-income countries. As the FDA estimates that 11.3% of rejected NCEs were due to CMC issues, this database is a significant achievement which should reduce the failure rate of potentially life-saving treatments.

Additionally, it is estimated that 15% of total R&D expenditures are spent on CMC-related development and regulation. Trained professionals in this area are in high demand in order to reduce timelines and costs.

Learn more about our biopharmaceutical course offerings.