Merck announced the expansion of its high-potent active pharmaceutical ingredient (HPAPI) and antibody-drug conjugate (ADC) production capabilities and capacity at…
SAFC, a business division of Sigma-Aldrich, is a custom manufacturer and services provider for pharmaceutical and biopharmaceutical companies.
The company develops and commercialises biological drug products and complex small-molecule active pharmaceutical ingredients (APIs).
The company supports all the stages of drug development from the pre-clinical stage to the commercial stage. It develops cell culture products, high-purity inorganic materials for technology applications, organic synthesis of APIs and key intermediates, biochemical production and biopharmaceutical manufacturing services.
SAFC is also involved in emerging technologies in the chemical-biological API conjugation, solid state chemistry research, high potency APIs and viral products.
The SAFC HPAPI Verona facility near Madison in Wisconsin, US, was opened in April 2010. It has been specifically built to meet the increasing demand for Phase III and commercial HPAPI requirements from pharmaceutical companies.
The company also has operations in St. Louis, Arklow, Gillingham, Buchs, Sheboygan, Bangalore, Carlsbad, Kansas, Jerusalem and Wuxi.
SAFC Madison project
The new 51,000ft2 current good manufacturing practice (cGMP) pharmaceutical manufacturing plant is located on a 15-acre greenfield site in the Verona Technology Park.
The land was acquired from Livesey Co. for $2.3m. Construction of the SAFC Verona facility was started in October 2008 and completed in December 2009.
The Verona Technology Park site was chosen for the new facility due to its proximity to the existing SAF plant and readily available infrastructure. It was built at an investment of $31m. The Verona facility is the second SAFC site in the Madison area, the other being a 63,000ft2 facility in the University of Wisconsin’s Research Park. The Research Park Tetrionics 23,500ft2 facility was built in 2000.
It was acquired by Sigma-Aldrich in June 2004. The facility underwent a 38,000ft2, $12m expansion in 2006 for its current size. It has eight process development laboratories, eight GMP kilo laboratory suites, two HPAPI drying and packaging rooms, a 200l pilot plant suite, 400l pilot plant suite and 800l main pilot plant suite, analytical laboratories, one hydrogenation suite and a solvent storage area.
SAFC Wisconsin’s Research Park facility has about 85 employees. The Verona facility will have 30 employees by 2013.
The project received seven-year, $1.2m tax incremental financing from the Verona’s Common Council in October 2008 and $292,500 from the Wisconsin Enterprise Development Zone in tax credits.
Verona Technology Park-based facility
The Verona site is a commercial-scale facility established to increase the production capacity of highly potent pharmaceutical ingredients. It has been designed, built and validated for safe handling and maximum efficiency of highly potent pharmaceutical ingredients.
The facility has two 200l mini processing reactor suites, two 2,000l reactors suite and two 4,000l reactors suites to produce the HPAPI compounds in batches. Other facilities at the plant include quality control laboratories specifically designed for HPAPIs, storage areas, a warehouse for refrigerated finished products and personnel offices. The facility design allows for future expansions.
Both of the Madison area facilities are dedicated to the production of primary, potent ingredients for the development of new and commercial production of pharmaceutical drugs.
The facilities produce HPAPIs for oncology and low-dose Vitamin D analogues for cardiovascular and autoimmune diseases.
The indications are expected to grow due to development of new potent compounds. The high potency market is also growing at a rate of double digits because of the advancements in clinical pharmacology and oncology.
SAFC outsources production from small and emerging pharmaceutical companies to major life-science corporates.
Licensing / certifications and contractors
The manufacturing plant complies with the HPAPI containment and handling standards for category IV and cytotoxics compounds. It also meets the quality standards set by the US Food and Drug Administration (FDA) for pharmaceutical production.
The facility received the SafeBridge Certification from SafeBridge Consultants in October 2011.
The certification was awarded based on the review of safety, health, training, management, communication and education programmes at the facility.
Vogel Bros. Building was the lead design-build contractor for the SAFC Verona facility. Flad Architects was the designer.
Affiliated Engineers was the engineering consultant. General Heating and Air Conditioning provided the HVAC design and installation services for the facility.
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