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SAFC Pharma augments assay development capabilities

September 10, 2015

Located adjacent to the Company's existing flagship viral substance production facility, the new laboratories support SAFC Pharma's biologics offering for customers in the pharmaceutical and biotechnology markets, and complement its existing portfolio of biologics capabilities through process improvement, technology transfers of processes and assays, and characterization of active ingredients.

The new complex includes a dedicated Polymerase Chain Reaction (PCR) facility, a tissue culture laboratory and stability suite supported by microbiology and regular testing labs, and houses a scientific team focused on Quality Control (QC), Process Development (PD), assay development and validation. The new PCR facility consists of separate suites with uni-directional personnel flow for sample processing, reaction assembly and PCR amplification. In addition to PCR assays, the unit is capable of performing cell-based, molecular and immunological assays, as well as analytical assays such as HPLC. All suites are equipped for independent air handling with air pressure gradients to prevent cross-contamination.

On-site QC functions will include environmental monitoring and microbiology, stability, product and raw materials release, plus analysis of in-process samples using advanced instrumentation. All standard operating procedures and protocols to be carried out in the laboratories are designed to follow cGMP guidelines.

Commenting on the commencement of operations, SAFC President Gilles Cottier stated: "Our investment in this world class facility at our Carlsbad campus underlines SAFC's continued commitment to building capabilities in important emerging new technologies such as viral vaccines and gene therapies - areas where SAFC sees great potential. As new and increasingly complex products make their way to commercialization, SAFC will continue to be strongly positioned to collaborate fully with its partners and customers on the development and production of treatments for cancer, cardiovascular and central nervous system diseases."

Commissioning of the new laboratories at Carlsbad follows SAFC's 2008 announcement of a $12 million expansion at the site to construct two fully segregated manufacturing suites. Due to be operational before 2009 year end, these suites will add an additional 8,000 sq. ft. of manufacturing space and enable 100 liter batch production in stirred tank bioreactors and 500 - 1,000 liter batch manufacturing in disposable bioreactors. The expansion will add commercial manufacturing capacity within the current 44,000 sq. ft. site and is planned to be Biosafety Level 2 compliant, allowing manipulation of human pathogens.

SAFC is the custom manufacturing and services group within Sigma-Aldrich that focuses on high-purity inorganics for high technology applications, cell culture products and services for biopharmaceutical manufacturing, biochemical production and the manufacturing of complex, multi-step organic synthesis of APIs and key intermediates. SAFC has manufacturing facilities around the world dedicated to providing manufacturing services for companies requiring a reliable partner to produce their custom manufactured materials. SAFC has four focus areas - SAFC Pharma, SAFC Supply Solutions, SAFC Biosciences, and SAFC Hitech - and had annual sales of nearly $600 million in 2007. SAFC is one of the world's 10 largest fine chemical businesses.

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