吡哆醇盐酸盐 [维生素B6盐酸盐]，Pyridoxine hydrochloride [PN HCl, VB6 HCl]；EMPROVE® EXPERT, Ph. Eur., BP, JP, USP, FCC

For protein-based therapeutics, such as monoclonal antibodies (mAbs) or plasma derived proteins, often highly concentrated protein formulations are required to meet intended dosing regimens. However, this usually comes with elevated viscosities and presents a challenge in the manufacturing process and final formulation. Our Viscosity Reduction Excipient Platform reduces the viscosity and helps overcome challenges associated with highly concentrated protein solutions.
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation.
Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

 

The Viscosity Reduction Platform is based on the combination of two new excipients, one amino acid component with one anionic component, that together can better reduce protein viscosity beyond levels achieved with single excipients. Also, combining the two components enables a balance of viscosity reduction and protein stabilization. Pyridoxine hydrochloride Emprove® Expert is part of this new proprietary technology platform. Also, Pyridoxine hydrochloride (Vitamin B6) is used in clinical nutrition for treatment of vitamin B6 deficiency, anemia, mental retardation, Parkinson′s syndrome, gestational diabetes, tetanus and atherosclerosis.

 

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany