Pfanstiehl has announced the launch of a new high purity, low endotoxin, Maltose (USP/NF, EP, JP), manufactured in the US under strict cGMP, ICH Q7 compliant conditions. “Maltose is a multifunctional disaccharide used to stabilize protein therapeutics, intravenous IG infusions and as a bioprocessing aid. We are pleased to be able to make such a high quality material available for our clients,” says Dr. Christopher Wilcox, VP, Sales & Marketing at Pfanstiehl.
Maltose has demonstrated a unique ability to prevent aggregation in IVIG solutions and to act as a bulking agent in final formulations. It should be considered alongside other tried and true carbohydrates such as trehalose, sucrose and sorbitol when developing platforms for stabilizing mAbs, ADCs and vaccines.
Pfanstiehl is focused on building on its rich heritage by investing in new product development and expanded capacity to meet the growing demand for pure, cGMP-produced components for process developers and formulators. 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 owing 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 with supply chain traceability.
Known for nearly a century for its first-in-class carbohydrate chemistry expertise, Pfanstiehl has built a reputation for high quality, cGMP-produced biopharma components and highly potent APIs at its US headquarters north of Chicago. For more information about Pfanstiehl and Pure Formulation Solutions, visit www.Pfanstiehl.com.