Prolient takes major step forward in BSA production

A new facility housing the technology has been opened, which contains many process innovations and includes one of the largest and most efficient biological lyophilizers (freeze-driers) in the world.

This gives Prolient control over the drying and packaging phase of the BSA production process, allowing it to do everything in-house.

BSA plays a vital role in medical diagnostic assays, life science research reagents, microbiological media and pharmaceutical and veterinary culture media.

Prolient believes that the advances it has made in BSA manufacturing enable to it to produce a consistently higher quality product.

Randy Fitzgerald, executive vice president of operations for the company, said: " We are already the only company that personally touches every aspect of its production.

We own the collection and transport of raw material for production of BSA, which really is a must for true consistency and traceability .

" Now we have introduced a finishing suite that gives us a superior ability to isolate and control the product during the critical drying and packaging phase ."

This level of control over the whole supply chain should prove reassuring to users of BSA given current concerns over contamination at different stages of product production.

Prolient has also been pioneering in its use of technology, with this latest facility utilising a sterile bag-in-tray system and fully dedicated stainless steel chamber.

Through this system the company believes that a contaminant-free product can be produced at the end of the drying cycle.

This product is then sifted and packaged in a HEPA-filtered and monitored dry clean room to ensure that no contamination occurs at this final stage of the process.

Prolient claims its BSA is low in endotoxin's, bioburden and virtually protease and IgG-free.

In addition it has the lowest levels of fatty-acids in the industry, according to the company.

By using BSA that is virtually contaminant free the chances of background interference when performing assays is reduced.

These claims of low levels of impurities are fairly standard within the sector, with Seracare's promotional releases containing similar language.

However, since entering the BSA market in 1999 Prolient has proven successful and now claims to " serve more than half the world market for bovine albumin ".

BSA production had failed to move on sufficiently from its 1940s heritage, when it began using similar techniques and equipment to human serum albumin production.

Prolient set up using closed, computer-monitored system with continuous-flow in-line centrifuges and modern filtration skids instead of the open vats and filter presses which had historically been used.

The improved technology, coupled with the withdrawal from the market by the previously dominant Centeon, has allowed Prolient to establish itself.

This latest improvement to its processes suggests that Prolient is keen to continue innovating as it strives to maintain its position in the market.