SAFC Biosciences takes dynamic approach to biopharma market

SAFC Biosciences, formed through the combination of Sigma Aldrich's Industrial Cell Culture business and JRH Biosciences, following the acquisition of JRH in March 2005, is to introduce four developments by the end of the year to meet the needs of the dynamic biopharmaceutical market.

The fourth quarter of 2006 will see the launch of its Developmental Services, which will combine new laser-based technology with existing media optimisation services with the aim of selecting highly productive clones together with specific cell line optimised media. The new technology will not only identify which are the high producing clones in the transfected cell pool, but will also destroy the non-producing or the low-producing clones.

According to Archie Cullen, vice president, sales and marketing at SAFC Biosciences, productivity of 10g/litre could be possible - a 50-fold increase compared with the productivity currently achieved for some of the biotherapeutics being produced today - and could bring down the economic barrier to manufacturing biotherapeutics.

The second major development will be the launch in November of EBx serum-free media (SFM) as an alternative to eggs to support growth and productivity of viral vaccines. Developed in collaboration with Vivalis, EBx SFM is currently in trials with a number of the major vaccine companies at the moment, said Cullen.

The move to serum-free media is well under way with early major approved therapies being relaunched and all new therapies being developed and launched in SFM. 'That is a big change to the industry as serum is a large part of the revenues in the biotech supply side of the business,' Cullen stressed. 'Probably around 50% of the value of the raw materials is attributed to serum.'

'But it is not enough to say your manufacturing process is animal-free. People now want the plants in which the media is made to be animal-free to prevent the risk of cross-contamination to the raw materials.' With global manufacturing capabilities consisting of five industrial scale GMP plants, of which two are in Europe, allowing both animal component-free and standard production, SAFC Biosciences is well positioned to meet this demand, he believes.

Thirdly, SAFC Biosciences will introduce improved hydrolysates next month. These have been developed in conjunction with Dutch company DMV and are designed to address the two key performance areas of consistency and productivity.

Finally, the company will continue to develop its range of single use disposables. The Bioeaze brand is the product of a collaboration with US-based ASI, of Pennsylvania, and offers both custom design and manufacture of single use systems for handling, storage and processing. New products are likely to be based around the bulk handling of liquids, Cullen stated, particularly containment and transport systems to ensure the safe handling of 1,000-litre bags.

SAFC Biosciences is the joint number one supplier of critical cell culture related raw materials to approved drugs in global biopharmaceutical market and is building further market share in the pre-approved segment with its appointment as primary supplier to more than 20 new drugs in the first half of 2006.