High Potent Manufacturing

SAFC is a leader in the fast-growing Highly Active Pharmaceutical Ingredient (HPAIs) manufacturing area. HAPI molecules are proven to be effective at much smaller dosage levels than traditional APIs, but their potent characteristics present specific handling challenges.

  • 20 years of experience in HAPI 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

Highly Active Small Molecule APIs

SAFC’s Madison and Verona, Wisconsin facilities have a complete range of kilo labs, pilot plants and commercial capabilities for the manufacture of HAPIs. Incorporating appropriate room pressurization, airlocks, ventilation and isolators to properly handle these highly potent materials. The sites have been certified by SafeBridge since 2003 to work with HAPI compounds. The new Verona, Wisconsin facility was certified in 2011.

Antibody-Drug Conjugation (ADC)

SAFC is one of only a handful of manufacturing companies that can combine the critical expertise both in HAPI and biologics to commercialize high-potent conjugates. SAFC has dedicated high-containment cGMP suites in St. Louis, Missouri, specifically designed for conjugation of HAPIs to antibodies or other therapeutic proteins, to combine high potency materials for use in targeted therapies. These suites have been SafeBridge-certified since 2009.

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