High Potent APIs

High potent active pharmaceutical ingredients (HPAPI) are effective at much smaller dosage levels than traditional APIs, but their potent characteristics present specific handling challenges.  As a leader in this area, we offer:

  • 25 years of experience in HPAPI development and manufacturing
  • Purpose-built SafeBridge®-certified facilities with specialized containment engineering
  • Extensive quality and regulatory experience with active DMFs filed in over 30 countries
  • Single point of contact project management

Our SafeBridge®-certified facilities in Madison and Verona, Wisconsin maintain a complete range of kilo labs, pilot plants and commercial capabilities for the manufacture of HPAPIs and appropriate room pressurization, airlocks, ventilation and isolators to properly handle these materials. We combine industry leading expertise in HPAPI and biologics to commercialize high-potent conjugates.

These facilities complement our ADC manufacturing facility in St. Louis, Missouri. This site is specifically designed for conjugation of HPAPIs to antibodies or other therapeutic proteins for use as targeted therapies. It was the first commercial ADC facility in North America and offers dedicated high-containment cGMP suites, which have been SafeBridge®-certified since 2009.