cGMP Mannose Launch

Pfanstiehl Launches cGMP-produced Mannose for Cell Culture Media Optimization & Glycoprotein Biosynthesis
September 30, 2014

Pfanstiehl has announced the launch of cGMP-produced, high purity Mannose (USP/NF, EP), manufactured in the USA under ICH Q7 compliant conditions. “Mannose has long been recognized for playing a key role in protein glycosylation. Now, there is a growing body of evidence that media supplementation with mannose can improve overall culture performance and consistency of protein glycosylation,” according to Dr. Christopher Wilcox, VP, Business Development at Pfanstiehl. “Process scientists have made great strides in elevating monoclonal antibody expression levels in mammalian cell lines, but have observed that product quality can often suffer or be a source of inconsistency. Having a ready source of high purity mannose available for media enhancement will add a valuable tool to the media toolkit for innovators and biosimilar producers while serving to expand awareness of this carbohydrate’s positive attributes”.

Pfanstiehl is focused on building on its rich heritage by investing to meet the growing demand for highly consistent, pure, and functional solutions for process developers and formulators. Cynthia Kerker, Pfanstiehl’s President, states, “We are focused on delivering solutions to the challenges brought to us by our customers. We believe that by smartly expanding our range of high purity biopharma components, we will enable our clients to achieve their formulation goals without compromising on quality.” As the industry undergoes the transformation from small molecule therapeutics to biologics, scientists face the often daunting task of screening an endless array of media components and excipients from across the globe, while trying to gain an understanding of the supply chain and regulatory complexities that exist for those materials. Often, they find that resources have been squandered and time lost due to inconsistent quality or compliance limitations at the source. The global regulatory environment, now more than ever, dictates that these critical materials not only function properly, but be of cGMP quality, be from a reputable source, and be of non-animal origin. For more information about cGMP Mannose, visit http://www.pfanstiehl.com/mannose/.

Since shedding Ferro in April of 2013, Pfanstiehl has been focused on bringing a new generation of formulation and bioprocessing solutions to its biotech and pharmaceutical clients worldwide. Known for nearly a century for its first-in-class carbohydrate chemistry expertise, Pfanstiehl has built a reputation for high quality, cGMP-produced excipients and highly potent APIs at its USA headquarters north of Chicago.

Need more information?

For more information about Mannose and other Pure Solutions