High Potent Manufacturing
SAFC is a leader in the fast-growing Highly Potent Active Pharmaceutical Ingredient (HPAPIs or HPAIs) manufacturing area. HPAPI 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 HPAPI 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
High-Potent 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 HPAPIs. 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 HPAPI compounds. The new Verona, Wisconsin facility was certified in 2011.
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.
SAFC has a new containment facility based in Israel that focuses on production of secondary metabolites, cytotoxins and highly potent large-molecule proteins. The Israel fermentation facility includes XP clean room suites and containment pressurization.
Microbial fermentation is necessary for manufacturing such pharmaceutical and biopharmaceutical actives as small organic molecules, proteins, cell wall components (e.g. Lipopolysaccharides, Lipid A) and DNAs. Product diversity makes fermentation technology a multi-disciplinary expertise associated with microbiology, organic chemistry, biochemistry and molecular biology. Another level of complexity is revealed upon Biosafety Level 2 Large Scale (BSL2-LS) fermentation utilizing Risk Group 2 (RG2) pathogens, and occasionally processing in explosion proof environments.
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