The Pharma division of SAFC, a member of the leading Life Science and High Technology company, Sigma-Aldrich Group (SIAL) has completed the expansion of its Carlsbad, California facility. The facility conducts contract-manufacturing services for SAFC’s late phase and commercial clients.
The $12 million expansion project included the addition of two fully segregated viral product-manufacturing suites built to employ the latest in disposable bioreactor technologies. This is aimed to expand SAFC Pharma’s biologics, viral vaccines and gene therapy manufacturing to commercial quantities.
SAFC Pharma’s Carlsbad site specializes in the process development and manufacturing of viral vaccines and viral therapeutics − including a full menu of support services − from preclinical process and analytical development to final fill/finish and commercial bulk drug supplies. The new expansion, designed for multi-lot campaigns, includes dedicated cell expansion, bioreactor production, purification and cleanroom suites. The expansion will enable both 100-liter batch production in stirred tank bioreactors and 1,000-liter batch manufacturing in disposable bioreactors and is Biosafety Level 2 compliant, allowing manipulation of human pathogens.
SAFC has announced worldwide investments totaling $90 million to expand capacity for active pharmaceutical ingredients production and biologic drug products. With respect to this, SAFC’s Pharmorphix Solid State Research Laboratories in Cambridge, UK have recently installed a new single crystal X-ray diffraction system. The Oxford Diffraction SuperNova™ system, which can determine the crystal structures from the most challenging crystal samples, is the first industrial installation in the world.
Equipped with a powerful high flux dual wavelength microsource X-ray generator, the SuperNova instrument is capable of performing single crystal X-ray analyses on small microcrystalline fragments with dimensions of 30 to 50 microns. The dual wavelength capability will allow the rigorous determination of absolute stereochemistry of chemical entities, which contain first row elements only. Solid-form characterization and research is an essential part of the drug development process.
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