Highly Potent APIs – Markets, Myths and Manufacturing
How does a CMO handle complexity?
The production of non-potent small molecule drugs accounts for the vast majority of API manufacturing capacity. Nonetheless, clinical successes and growing press surrounding small molecules focused on oncology indications and cancer growth inhibitors has created somewhat of a gold rush of commercial interest in highly potent active pharmaceutical ingredients (HPAPIs).
Terminology such as ‘high potency’ and ‘highly potent molecules’ have almost become cliché as the number of contract manufacturing organizations (CMOs) that claim to be able to handle them proliferates. However, as recently as the last decade, the list of CMOs that could legitimately manage the hazards associated with manufacturing HPAPIs could be counted on just one hand.
So what’s different about this webinar?
It can be tempting to assign high potency to a small molecule in this therapeutic class and in many cases this serves as a conservative approach. Perhaps the greatest challenge for toxicological assessment is that these molecules may be highly potent toward cancer cells and yet pose minimal hazard to healthy workers. This is an important departure from past toxicological assessment of legacy cancer drugs that act primarily through somewhat non-selective cytotoxicity.
HPAPIs and, in particular, small molecules being developed for oncology present a new set of challenges for CMOs charged with safe handling during process development, clinical and commercial production. In the context of recent developments and investments made by Cambrex in high potency manufacturing, this webinar will:
- Provide an overview of the current HPAPI market
- Introduce HPAPI toxicological assessment
- Explain why there is variability between assessments
- Discuss how variability may impact containment strategies and cost
- Share ideas about how to tailor and customize manufacturing strategies for next-generation small molecules in targeted cancer therapy
Dr. Matthew Moorcroft, VP of Global Marketing, Cambrex
Jeff Pavlovich, Cambrex Senior Process Safety Engineer
Dr. Mark S. Maier, Managing Partner, Sheperian Toxicology