cGMP Mannitol Launch

Pfanstiehl Launches cGMP-produced, Parenteral Grade Mannitol for Pharmaceutical Formulations
December 1, 2014

Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/NF, EP, JP), manufactured in the US under strict cGMP, ICH Q7 compliant conditions. “Mannitol is a tried and true platform excipient used in a wide range of therapeutic formulations. We are pleased to be able to make such a high quality material available for our clients,” says Dr. Christopher Wilcox, VP, Business Development at Pfanstiehl. Mannitol has demonstrated its utility as a stand-alone lyoprotectant or bulking agent, as well as in combination with other high purity excipients like trehalose and sucrose to stabilize a variety of systems including mAbs, ADCs, vaccines, and small molecules.

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 are focused on delivering solutions to the challenges brought to us by our customers. We believe that by smartly expanding our high purity components portfolio, we will enable our clients to achieve their formulation goals without compromising on quality or performance.” As the industry works to balance development of both small and large molecule therapeutics, 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.

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.

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