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Highly Active and Complex API Development & Manufacturing

SAFC’S leading position in the fast-growing Highly Potent Active Pharmaceutical Ingredients (HPAPI) market includes conjugation of HPAPIs to antibodies for exciting new anti-cancer drugs. HPAPIs are proven to be effective at much smaller dosage levels than traditional APIs, but their potent characteristics present specific handling challenges. With more than 20 years experience in HPAPI manufacturing, SAFC’s purpose-built facilities with specialized containment engineering ensure the reliable, safe and quick handling of HPAPIs throughout the development process.

highly-potent-apis

Highly Potent Small Molecule APIs

SAFC’s Madison, Wisconsin facility has a complete range of kilo labs, pilot plants and commercial capabilities for the manufacture of HPAPIs.This facility incorporates appropriate room pressurization, airlocks, ventilation and isolators to properly handle these highly potent materials. The site has been certified by SafeBridge® since 2003 to work with HPAPI compounds. The new Verona, Wisconsin facility was certified in 2011.

High-Potent Conjugation

SAFC is one of only a handful of manufacturing companies that can combine the critical expertise both in HPAPI and biologics to commercialize high-potent conjugates.

SAFC has dedicated high-containment cGMP suites in St. Louis, Missouri, specifically designed for conjugation of HPAPIs to antibodies or other therapeutic proteins, to combine high potency materials for use in targeted therapies. These suites have been SafeBridge-certified since 2009.

Analytical Services

SAFC provides complete analytical support, including development of specifications, risk-assessment and implementation of process controls.

  • Analytical capabilities includes:
– Amino Acid Analysis (AAA)
– Bioburden
– DSC
– Electrophoresis
– ELISA
– Endotoxin
– FT-IR
– GC
– GCMS
– HPLC
– IR
– KF
– LCMS
– NMR
– TGA
– UHPLC
– UV
– X-ray diffraction

 

  • Phase-specific analytical development and method validation
  • Characterization, certification and control of incoming raw materials
  • Quality Control (QC) testing of in-process materials
  • Release testing available
  • Stability studies of drug substance and drug product

Clinical to Commercial

The company provides comprehensive development and manufacturing services for HPAPIs in FDA-inspected facilities from clinical to commercial-scale quantities.

Quality Management

  • Dedicated Quality Assurance (QA) units
  • Highly experienced personnel
  • Operations to industry standards
    – Proven and experienced quality assurance oversight for HPAPIs
    – Clinical trials APIs manufactured to CH Q7A guidelines
  • Rigorous compliance program in place

Project Management

SAFC’s project managers lead multi-functional teams in support of custom cGMP projects.

Our project managers serve as a single point of contact for customers and help facilitate the timely communication of important technical information and production timelines.