Pfanstiehl has launched a high purity, low endotoxin mannitol, manufactured in the US under strict cGMP, ICH Q7 compliant conditions.
Mannitol is used 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 a variety of systems including mAbs, ADCs, vaccines and small molecules.
With its expertise in carbohydrate chemistry expertise, Pfanstiehl provides functional solutions for process developers and formulators based on excipients and highly potent APIs produced in cGMP facilities at its US headquarters north of Chicago. Cynthia Kerker, Pfanstiehl’s President, 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.’
Mannitol is a sugar alcohol derived from the sugar mannose by reduction. Its physical properties make it suitable for use as a bulking agent in tableting. However, it also has chemical properties that enable it to stabilise a variety of pharmaceutical preparations, including liquid formulations, as well as protect proteins from denaturation/degradation upon lyophilisation, spray drying, and reconstitution.
Pfanstiehl brand high purity low endotoxin (HPLE) mannitol was developed specifically for biopharmaceutical use, to the highest quality and purity standards. It can be used as a key component to stabilise proteins during formulation, freeze drying and finish/fill applications. Benefits include enhanced protein therapeutic stability, vaccine stabilisation, and providing a carrier in lyophilised and spray dried formulations.
The ingredient is available as US, European and Japanese Pharmacopoeia (USP, EP, JP) standard.
