Should You Choose A Commercial HPAPI Manufacturer For Your Clinical Program?

By George Hlass and David Bastie, Fareva

The percentage of drug candidates in the pharmaceutical pipeline based on highly potent active pharmaceutical ingredients (HPAPIs) is rising steadily, owing to the rapid growth of the oncology segment and a growing tendency toward a more conservative estimate of the potency of new chemical entities.

The safe manufacturing of highly potent compounds requires highly specialized facilities, equipment, technologies and expertise. The investment to build a commercial HPAPI facility can easily cost tens of millions of dollars and take years to properly qualify before the first commercial product can even be considered. While some large pharmaceutical companies are willing to invest in these capabilities, many do not, while small and emerging firms typically lack the resources and specifically the expertise to do so. Consequently, demand for HPAPI outsourcing services has risen dramatically, placing a strain on contract development and manufacturing organization (CDMO) capacity, despite ongoing investment in the sector.

Switching from an early-phase CDMO to a commercial-scale manufacturer for your highly potent active pharmaceutical ingredient (HPAPI) projects can be costly and lead to project delays. Partnering from the outset with a CDMO capable of supporting HPAPI projects from concept to launch can accelerate development timelines and reduce overall costs.