FocusDisposable bioreactors get boost

22 February 2008 21:35  [Source: ICIS news]

By Feliza Mirasol

NEW YORK (ICIS news)--The biopharmaceutical industry can expect to see a wider use of stirred tank disposable bioreactors for manufacturing biologic drugs in the near future, industry sources said on Friday.

“We are already selling our technology to companies that are planning to use our system for commercial production within a couple of years or less,” said Parrish Galliher, founder, president and chief technology officer of Xcellerex, a Marlborough, Massachusetts-based company that develops single-use stirred tank manufacturing technology for biomolecules.

“It’s going to happen very quickly,” he said. “The economics and advantages are so compelling for companies, and the FDA [Food and Drug Administration] has already accepted INDs [Investigational New Drug Applications] for drugs manufactured with this technology.”

The primary benefits of using disposable bioreactors include a significant cost cut, a quicker installation and set up, and simpler cleanup, according to proponents of the system. These factors add up to a quicker turnaround time for process changes and potential for extra batch runs.

Lonza, a world-leading biologics manufacturer, agreed with the general assessment, although fixed stainless steel reactors will remain in place for larger scale production requirements.

“We are highly likely to see the spread of disposable reactors but this will be within a certain volume range. Vendors are currently looking at scales up to around 2,000L. Beyond this scale, stainless steel reactors would tend to be the option chosen,” said Dominik Werner, media relations, Lonza. 

Industry trends driving the use of disposable technologies in manufacturing include the shift towards more personalised medicines and the shrinking of niche drug markets. Basically, drugs currently moving through the pipeline are more highly potent and therefore require lower dosages than traditional low potency, high volume biopharmaceuticals already on the market.

Disposable bioreactors are tailor-made for these newer drugs, according to proponents of the disposable system.

“I think disposables fit perfectly with those trends of niche drugs and personalised medicines, because these areas lead into smaller batches of more products. Disposable reactors are really ideal in the small-to-medium scale,” said Howard Levine, founder, president, principal consultant of BioProcess Technology Consultants.

By: Feliza Mirasol
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