Viscosity Reduction Platform by Merck

Carrying out intended dosing regimens often require highly concentrated protein formulations that may be too viscous for subcutaneous administration or other routes of administration that are limited by volume. While reducing viscosity with a single excipient can be ineffective or compromising protein stability, Merck/Millipore Sigma’s viscosity reduction platform of new excipient combinations offers a variety of manufacturing and final formulation benefits:

  • Efficient viscosity reduction via synergistic excipient combinations
  • Platform flexibility with the right solution for your protein
  • Maintenance of protein stability
  • Well characterized safety profile (prior parenteral in-human applications and toxicological assessment available upon request)
  • IP protection for competitive differentiation

The result: subcutaneous administration of protein-based therapeutics to improve patient compliance and help avoid hospitalization.

Enabling subcutaneous formulation of biologics

Merck/Millipore Sigma’s viscosity reduction platform of new excipient combinations enables subcutaneous formulation of highly concentrated protein biologics, bringing together increased concentrations and improved downstream processing. As part of Merck/Millipore Sigma’s industry leading Emprove® Program, all excipients are or will be made available in Emprove® Expert quality to support your clinical development and commercialization helping you to minimize regulatory and quality-associated risks.

  • Full supply chain transparency
  • Support of risk assessment and management
  • Online access to regulatory information
  • IPEC-PQC GMP compliance and supporting documentation
  • Lowest microbial and endotoxin levels for high-risk applications

Additional information:

Tool: Risk Mitigation and Quality Requirements

User Guide: Experimental Procedures to Evaluate the Viscosity Reduction Platform

Webinar: The Viscosity Reduction Platform – Enabling Subcutaneous (subQ) Delivery

Poster: Excipient combinations to manage protein viscosity for highly concentrated formulations

White paper: Viscosity reducing excipients for protein formulation

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