Complex Molecules, Complex Problems

By Charles Johnson, Senior Director, Commercial Development, Lonza Small Molecules

The growing complexity of the small molecules progressing through the pharmaceutical pipeline throws the need for manufacturing expertise and experience into sharp focus. It is a particular issue for small, emerging biotech companies who are unlikely to have such capabilities in house. Whether that complexity arises from difficult chemistry, long synthetic routes or even the compounds' insolubility, the challenges in turning a molecule into an effective dosage form have never been greater.

Many of these drugs are now on some form of accelerated approval pathway, making it something of a race to make the active pharmaceutical ingredients (APIs), find appropriate formulations and push through the clinical phases as fast as possible. Add in the fact that there is a growing trend for small companies to take assets further into the development pipeline themselves rather than partnering or selling out to big pharma after Phase 1, if not progressing them all the way to market themselves, and the need for manufacturing support becomes abundantly clear.

Two good examples of where the support of an experienced contract development and manufacturing organization (CDMO) is critical to overcoming complexity is when working with an highly potent active pharmaceutical ingredient (HPAPI), and when solubility challenges need to be solved.