WAUKEGAN, Ill., March 31, 2014 /PRNewswire/ -- Pfanstiehl just announced the launch of its new high purity, low endotoxin, non-animal-derived Galactose (USP/NF, EP), manufactured in the US under strict cGMP, ICH Q7 compliant conditions. "Process scientists have observed the benefits of Galactose as a cell culture media component for years, but have had difficulty justifying the use of an animal origin or non-cGMP material," says Dr. Christopher Wilcox, VP, Business Development at Pfanstiehl. "Galactose has been demonstrated to reduce lactate and ammonia formation, thereby enhancing overall culture performance and yield. With a high purity, cGMP-produced, animal free solution now available, Galactose is likely to gain even more recognition as a critical component of media for the production of novel protein therapeutics and biosimilars."
Pfanstiehl is focused on building on its rich heritage by investing in new product development and expanded capacity to meet the growing demand for highly consistent, pure, and functional solutions for process developers and formulators. Cynthia Kerker, Pfanstiehl's President, states, "We have a renewed focus on delivering solutions to the challenges brought to us by our customers. We believe that by smartly expanding our High Purity excipients portfolio, 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 are being challenged with 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. All too often, they are finding 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 are of cGMP quality, are from a reputable source, and are of non-animal origin. For more information about Non-Animal Galactose, visit www.pfanstiehl.com/galactose-nad.
Since shedding Ferro in April of 2013, the newly independent 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 US headquarters north of Chicago. For more information about Pfanstiehl and Pure Formulation Solutions, visit www.Pfanstiehl.com.