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New excipients for protein-based drug products reduce viscosity while maintaining protein stability.
MilliporeSigma announced the launch of the Viscosity Reduction Excipient Platform for protein-based therapeutics on Oct. 4, 2021. The platform is designed to reduce viscosity while maintaining protein stability, which should help therapeutic candidates overcome formulation challenges associated with highly concentrated protein solutions.
According to a company press release, subcutaneous administration is the preferred route for protein-based therapeutics, such as monoclonal antibodies or plasma derived proteins, because it improves patient compliance. However, because these formulations require highly concentrated protein formulations to meet intended dosing regimens, they tend to exhibit elevated viscosities that present challenges in the manufacturing and final formulation processes.
The program is based on the combination of two new excipients, an amino acid and anionic component. According to the press release, this combination allows for viscosity reduction beyond what is possible with a single excipient, allowing for an improved viscosity/stability balance that will help therapeutic candidates overcome these challenges.
Every excipient candidate in the platform has previously been used individually in approved drug products for humans through parenteral administration in functions such as active ingredients in parenteral nutrition or pH adjusters. They will all be made available in the company’s Emprove Expert portfolio, which is intended to accommodate current and upcoming regulatory requirements.