Madison, Wisconsin

SAFC Madison is our primary center of excellence for high-potency API (HPAPI) development and manufacturing. FDA inspected and one of the first facilities to be certified by SafeBridge® for potent compound handling, SAFC Madison maintains fully equipped process development suites, kilo labs, and fixed equipment plants staffed with experienced personnel knowledgeable in API development and manufacturing. The Madison complex includes a facility based in Madison, WI and a second large scale manufacturing facility located in nearby Verona, WI to provide a complement of clinical to commercial API manufacturing capabilities.

For more information, view the Madison/Verona facility insert (PDF).

Core Technologies

  • mg to 400 Kg GMP production
  • High Potency manufacturing
  • Cytotoxics manufacturing
  • Vitamin D analog manufacturing
  • Low temp (<-60°C) reactions
  • Chromatographic purification

Core Competencies

  • Clinical to Commercial scale
  • Custom cGMP synthesis and process development
  • Process validation capabilities
  • Analytical method development and validation
  • Quality control testing and stability programs
  • Quality Assurance and Regulatory Affairs departments
  • Global Regulatory experience
  • Project management expertise
  • HPAPI and linker manufacturing for use with Antibody Drug Conjugates (ADCs)

Capabilities/Equipment Overview

Eight process development labs:

  • 4 HPAPI development labs
  • 3 general development labs
  • 1 scale-up (to 50 L) lab

Eight GMP kilo labs featuring:

  • Barrier isolators
  • Powder weighing hoods
  • Closed system glassware
  • Portable processing equipment
  • Local exhaust ventilation
  • Chromatography systems
  • Class 100,000 (ISO 8) single pass HVAC
  • Dedicated glassware and equipment

Two HPAPI capable drying/packaging rooms

Three GMP pilot plants featuring:

  • Barrier isolators
  • Alpha beta valves for reactor charging
  • Chromatography systems (up to 40 kg cartridges)
  • Hastelloy Nutsche filter/dryer/isolators (HPAPI handling)
  • Class 100,000 (ISO 8) single pass HVAC
  • Dedicated suites for each project
  • Process equipment includes glass-lined reactors up to 800 L and Hastelloy® reactors up to 400 L for cryogenic reactions
  • Clean In Place (CIP) containment cleaning systems 

Two large-scale GMP plants featuring:

  • Barrier isolators
  • Powder transfer systems for contained HPAPI handling
  • 1M² and 2M² Hastelloy Nutsche filter/drying/isolators (HPAPI handling)
  • Load cells for reactors and filters/dryers
  • Class 100,000 (ISO 8) single pass HVAC
  • Process equipment includes glass-lined reactors up to 4,000 L, glass-lined work-up tanks up to 8,000 L, and a
  • 2,000 L Hastelloy reactor for cryogenic reactions
  • Clean in place (CIP) containment cleaning systems

Virtual Tours

cGMP Manufacturing

Small Molecule cGMP Manufacturing

Contact Facility

Facility Address:
645 Science Drive
Madison, WI 53711, USA
Tel: 608-233-3115 x107

Certificates & Documents

FDA Registration Numbers:
Madison: 2135204
Verona: 833146777

SafeBridge Certification

Request a Site Audit

Reach out directly to our team here to process / schedule your site audit.