Pfanstiehl has announced the launch of a new high-purity, low-endotoxin, Mannitol, which is manufactured in the US under strict current good manufacturing practices (cGMP) and ICH Q7 compliant conditions.
Pfanstiehl vice-president of business development Dr Christopher Wilcox said: "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."
Mannitol demonstrated its use as a stand-alone lyoprotectant or bulking agent, as well as in combination with other high-purity excipients, such as trehalose and sucrose to stabilise various systems including monoclonal antibodies (mAbs), ADCs, vaccines, and small molecules.
Pfanstiehl is focused on developing its rich heritage by investing in new product development and expanded capacity to meet growing demands for highly consistent, pure, and functional solutions for process developers and formulators.
Pfanstiehl president Cynthia Kerker said: "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 balances the development of small and large molecule therapeutics, scientists are challenged with the task of screening an array of media components and excipients worldwide, while trying to gain an understanding of the supply chain and regulatory complexities that exist for those materials.
Scientists often discover resources have been squandered and time lost due to inconsistent quality or compliance limitations at the source.
The global regulatory environment dictates that these critical materials not only function properly, but are of cGMP quality, from a reputable source, and are of non-animal origin.