SAFC expands two biotech manufacturing plants

Strategic expansion in SAFC's ADC offering is designed to help customers to scale ADC production seamlessly from preclinical to commercial phases

SAFC Commercial, the custom manufacturing services business unit of Sigma-Aldrich Corporation, has completed the expansion of its St Louis facility to support commercial-scale antibody drug conjugate (ADC) manufacturing. The facility is in final validation and expected to go online as planned in the third quarter of 2015. Once validated, customers will benefit from working with a single supplier from discovery to commercialisation.

The facility has been designed to meet SafeBridge category 4 compound handling, enabling it to accommodate usage of highly-active compounds. The expanded capabilities in St Louis are further enhanced by expanded commercial capacity for highly-active manufacturing and storage at the company’s site in Madison, Wisconsin.

SAFC offers cell-line engineering and media, linkers and payloads, along with significant conjugation expertise using both highly-active and non-potent compounds. The St Louis expansion complements other recent additions to the company's ADC capabilities, including the ADC Express service for preclinical ADC and bioconjugation services, and a collaboration with industry leader Baxter BioPharma Solutions for formulation and fill/finish services.

'The ADC market is a growing market, and is expected to expand over the next few years. This strategic expansion is the latest in a series of enhancements in our ADC offering designed to support this important therapeutic area and to help our customers to seamlessly scale ADC production from preclinical to commercial phases,' said Gilles Cottier, President of SAFC.

'Our offer can bring customers’ molecules to the clinic faster, with the ease of working with one supplier from start to finish. With the added support of our recently launched ADC Express service, we believe SAFC presents the most comprehensive offer in the contract manufacturing market.'

SAFC is also set to expand its facility in Carlsbad, California, to enable it to offer clinical and commercial bulk drug production, as well as fill/finish of viral products for its gene therapy, viral vaccine and immunotherapy customers.

'Gene therapy is an emerging technology, and our SAFC and BioReliance sites in Carlsbad, Rockville, and Glasgow have supported this growing industry for years,' said Cottier. 'This investment is pivotal to our customers and reflects SAFC’s continued dedication to providing the infrastructure customers need to bring their drugs to market.'

The expanded Carlsbad facility complements a global footprint of GMP services in the virus and gene therapy segment, including cell banking in Rockville, Maryland, and manufacturing in Glasgow in Scotland. The investment was driven by continued interest in targeted gene therapies for indications such as hemophilia and cancer immunotherapies (CAR-T cells).

The announcement of the expansion projects coincides with Sigma-Aldrich's Q1 results, which saw SAFC Commercial's sales reach US$166m, an increase by 4% compared with the first quarter of 2014. Organic sales growth was 10%, which was partially offset by a 6% reduction due to changes in foreign currency exchange rates.

'Our SAFC Commercial business unit was led by the seventh consecutive quarter of double-digit organic sales growth in the Life Sciences Services segment and solid growth in the Life Sciences Product segment,' said President and CEO Rakesh Sachdev.

'During the quarter, we launched new products such as the EX-CELL Advanced CHO Fed-batch System, a high-performing batch media system developed for a range of widely used industrial CHO cell lines, including SAFC's proprietary CHOZN cell line. We also launched Next-Gen Sequencing Oligos, which are adapters that improve target sequence assembly.

'We officially opened our dry powder media manufacturing facility in Irvine, Scotland, which now serves as the European counterpart to the Lenexa, Kansas, Center of Excellence for cell culture media manufacture and supply. In April, we opened our state-of-the-art Cell Culture Technical Center in Singapore to support our biopharmaceutical customers in this fast growing region,' he added.

'I think this is a momentous year for our company for many reasons, but first and foremost because we celebrate 80 years of existence,' said Cottier. 'It is also a momentous year because some time this year we are going to be acquired by Merck KG.

'Merck didn't buy us because we failed; they bought us because we are very successful.'

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