High Potency (HPAIs)
Specialized Technologies
 
SAFC Madison facilitySAFC has expertise in the development and manufacturing of small volume, highly potent and cytotoxic APIs. SAFC Madison (formerly Tetrionics) is considered one of the premier contract HPAI manufacturing facilities in the world because of its expertise in this area and is one of a few facilities that is certified by SafeBridge for potent compound handling. SAFC Madison works on development projects requiring chemistry that is difficult to handle because of its physical/biological properties or because the synthetic process is extremely long and complex requiring experienced personnel that understands the complexities associated with such processes.


Capabilities
API manufacturing requiring the ability to handle extremely difficult chemistry
Development and manufacturing of potent substances
Capabilites to handle complex multi-step organic synthesis
Category IV & Cytotoxic handling capabilities
Operating temperature range -80°C up to +180°C
Preparative scale HPLC and ozonolysis
 
9 - Process R&D Laboratories
9 - GMP Kilo Labs
2 - Pilot Plants (120 L - 800 L Reactors)
GMP Hydrogenation suite
2 - Category IV capable GMP drying/packaging suites
Analytical Development and Quality Control Laboratories
Separate quarantine and approved storage areas


Vitamin D Center of Expertise
SAFC Madison was founded on its expertise in vitamin D chemistry and the team is extremely accomplished in the scale up and manufacture of difficult-to-synthesize vitamin D analogs. SAFC Madison is the exclusive manufacturer of paricalcitol, the active ingredient in Zemplar®, an FDA approved drug marketed by Abbott Laboratories.

Recent Expansion
A major $12 million expansion of the high potency active pharmaceutical ingredients (API) facility at SAFC Madison has been completed. The 37,600 square foot expansion more than doubles the orignal factory and its cGMP manufacturing capacity. With the increase in demand for custom chemical manufacturing services for highly potent APIs, including category III and category IV compounds, the two-story structure adds several features: new analytical laboratories; expanded R&D laboratories; new kilo laboratories; a hydrogenation suite; cGMP drying/packaging suites; and increased warehousing and storage capacity.


SAFC Madison Facility Design
First Floor - 100k gif
Second Floor - 57k gif

 

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