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:

  • 30 years of experience in HPAPI development and manufacturing
  • Purpose-built SafeBridge®-certified facilities with specialized containment engineering
  • Extensive quality and regulatory experience, including an exceptional track record of positive customer and agency audits

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.

HPAPI offer to support ADC manufacturing

DM1 Mertansine for your drug conjugate programs is now available without licensing or royalty fees. We maintain an available stock to support your drug conjugation projects and accelerate your development timelines. Our proprietary maytansinoid synthesis can be modified to meet your specific linker-payload needs. Features include:

  • High purity material (HPLC Purity > 97%)
  • 100 mg samples available free of charge
  • MilliporeSigma-owned DMF/ASMF for regulatory filings
  • Validated analytical methods

Dolastatin Core is an advanced intermediate through which all known dolastatin 10 payloads can be made. This proprietary technology gives you added flexibility to make new or established dolastatins and can be modified to meet your specific linker-payload needs. Dolastatin Core provides exceptional time benefits by reducing the number of steps in the custom synthesis pathway. Advantages of our Dolastatin Core platform include speed to market and reduced supply chain complexity. We also offer phase appropriate regulatory support, free licensing agreements, and no royalty payments.

We are confident that this innovative solution will meet your critical timeline needs and get your program to the clinic faster.

Features include:

  • No chromatography. i.e. timely in-house cGMP process
  • Supply chain risk reduction – stock readily available
  • 5 g samples available free of charge

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.

World-Class Facilities Provide Supply Chain Confidence

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

Our API Contract Manufacturing Facility Locations

  • Madison, Wisconsin, USA (cGMP)
  • St. Louis, Missouri, USA (cGMP)
  • Sheboygan, Wisconsin, USA (non-cGMP)
  • Schaffhausen, Switzerland (cGMP)