On February 25th, I sat in eager anticipation awaiting the FDA’s decision on Protalix Therapeutics’ Uplyso (taliglucerase alfa), a unique and innovative therapy for Gaucher disease. The reason behind my fascination with Uplyso was the innovative means by which the product has been developed and manufactured. Rather than utilizing standard production methods through the use of mammalian cells similar to current Gaucher therapies marketed by Shire (Vpriv) and Genzyme (Cerezyme), Protalix’s therapy utilizes a unique and innovative production process (ProCellEx™) through plant cells (specifically genetically altered carrot cells), which has allowed the company to significantly streamline and scale the entire manufacturing process while at the same time reducing overall manufacturing costs. Perhaps even more exciting was the fact that the therapy would be the first plant cell based protein manufacturing platform to reach the market.
Posts Tagged ‘New Technology’
Protalix Therapeutics Receives a Complete Response Letter from the FDA: A Tale of Carrots and SticksMonday, March 7th, 2011
The adoption of single use bioreactor (SUB) technology continues to increase in the biologics manufacturers we work with. Initially confined to research and process development applications, we find more companies are beginning to apply disposable technologies to clinical and even commercial applications. Moreover, users of this technology are reporting that SUBs provide comparable results to stainless steel systems across several critical dimensions. As early adopters have overcome their initial concerns through experimentation, it appears that disposable bioreactor technologies have now reached an inflection point towards becoming more viable clinical and commercial production systems.