High Potent APIs

High Potent API

High Potent API Manufacturing

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 drug master files (DMFs) filed in over 30 countries

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 down to single-digit nanogram containment levels, featuring 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.

In addition, our ADC manufacturing facility in St. Louis, Missouri is specifically designed for conjugation of HPAPIs to antibodies or other therapeutic proteins used as targeted therapies. The first commercial ADC facility in North America, it offers dedicated high-containment suites that meet all standards for current good manufacturing practices (cGMP) and has been SafeBridge®-certified since 2009.

Offering you a world of capabilities

The global footprint of our API contract manufacturing services assures you of wide-ranging regulatory and supply expertise, easily accessed through a single trusted partner.

Our High Potent API Contract Manufacturing Facility Locations

  • Buchs, Switzerland (cGMP)
  • Madison, Wisconsin (cGMP)
  • St. Louis, Missouri (cGMP)
  • Schaffhausen, Switzerland (cGMP)

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Merck

Research. Development. Production.

We are a leading supplier to the global Life Science industry with solutions and services for research, biotechnology development and production, and pharmaceutical drug therapy development and production.

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