Madison, Wisconsin

Site Overview

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 compliment of clinical to commercial API manufacturing capabilities.

For more information, view the Madison facility insert (318 Kb PDF).

Core Technologies	Core Competencies
mg to 400 Kg GMP production	Clinical to Commercial scale
High Potency manufacturing	Custom cGMP synthesis and process development
Cytotoxics manufacturing	Process validation capabilities
Vitamin D analog manufacturing	Analytical method development and validation
Low temp (<-60°C) reactions	Quality control testing and stability programs
Chromatographic purification	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

Madison Virtual Tour

cGMP Manufacturing

Small Molecule cGMP Manufacturing

Certificates and Documents

FDA Registration Numbers:
Madison: 2135204
Verona: 833146777

SafeBridge Certification

Contact Madison

645 Science Drive
Madison, WI 53711
USA

Tel: (608) 233-3115 x107

Schedule a Site Audit
Request Quality Information

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