INFORMEX: Sigma-Aldrich sets its sights on biopharma

Rapidly growing biologicals sector a major factor behind investment

Sigma-Aldrich Corporation has completed its acquisition of BioReliance Holdings announced in January. BioReliance is a leading provider of global biopharmaceutical testing services and the deal marks the first foray of Sigma-Aldrich into the services arena.

BioReliance provides critical services, including biologic, specialised toxicology and animal health testing to the pharmaceutical, biopharmaceutical, diagnostics and other life science sectors.

BioReliance will become a new business unit within SAFC, the custom manufacturing and services business unit of Sigma-Aldrich, and will report directly to president Gilles Cottier.

The acquisition gives SAFC a foothold in the preclinical space, and the two companies have many customers in common, enabling them to leverage mutual relationships.

SAFC president Gilles Cottier

‘By 2014 it is expected that eight of the top 10 drugs will be biologics,’ said Cottier. ‘The combination of BioReliance and SAFC provides a richer value proposition for the development and manufacture of biological drugs.

‘The alliance provides an opportunity to combine our CompoZr zinc finger nuclease (ZFN) technology with BioReliance’s toxicology and animal health services operations for the development of new assays, cell lines and animal models for the research marketplace.’

SAFC has also launched PharmaGrade, a new grade of raw materials designed to meet the growing traceability needs of biopharma product manufacturers.

PharmaGrade is supported by Sigma-Aldrich’s Enhanced Quality Program, which was designed to ensure that the right grade of material is used for the right purpose by segmenting the supply chain into different grades, with increasing levels of purity and traceability. PharmaGrade has an exceptionally high level of control, and all the documentation required for biopharma processes.

With the increase in activity in the biopharmaceuticals field has come a growing burden on critical raw material suppliers and the innovator in terms of understanding the full supply chain. ‘Unlike small molecules, control is much more difficult with biopharmaceuticals,’ said director of marketing Dave Backer. ‘It’s important that all the components that are added to the culture meet the required standards from a manufacturing, quality, and supply chain standpoint.’

PharmaGrade products have the full traceability right back to the manufacturer of record, as required for bioproduction.

One of the most important materials now being supplied in PharmaGrade is L-methionine sulfoximine, which is made in the company’s Buchs, Switzerland facility. ‘About 50 materials are already available in this new quality, and we will be adding to the list as the year goes on,’ Backer added.

SAFC is also making a $1m (€752,000) investment in microreactor and continuous flow technology (CFT), with a large-scale facility set to open at its Sheboygan, WI plant in the third quarter of 2012. This facility will complement the company’s current large-scale batch manufacturing capacity, expanding the range of chemistries available at the site. A pilot-scale facility is also due to come on line in Milwaukee, WI in March for rapid development of new chemistries using CFT.

The company now has five r&d-scale reactors in place at its sites in Milwaukee and Buchs. According to process development manager Stefan Gladow, these further investments are being made in response to customer demand for reactions that may involve unstable or hazardous entities, or are not otherwise scalable using batch technology.

Flow technology offers many advantages over batch processing. Very short reaction times – often a few seconds – can give cleaner reactions, higher yields and thus a reduction in raw materials usage. It is often possible to optimise isolation so the product needs no additional purification, achieving further reductions in waste, materials and labour costs, and meeting many requirements of green chemistry.

Another advantage is the very small reactant volume, which reduces the potential for expensive failures that can occur with batch processing. The risks are also lower for hazardous reactions and unstable molecules, as only tiny amounts of dangerous materials are present in the reactor at any one time.

Examples of reactions SAFC has already run in continuous mode include large-scale diazo esters, azides, organometallic reactions such as lithiations and Grignards, high temperature reactions, halogenation and displacement reactions, and selective Boc protection procedures.

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