Merck

Viscosity Reduction Platform

Reducing viscosity of highly concentrated monoclonal antibody (mAb) formulation to enable subcutaneous delivery

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, our platform featuring combinations of viscosity-reducing agents provides a variety of manufacturing and final formulation benefits.

Enabling Subcutaneous Formulation of Biologics

Our Viscosity Reduction Platform enables subcutaneous formulation of highly concentrated protein biologics, bringing together increased concentrations and improved downstream processing.

Our offering comprises:

  • Proprietary new excipient combinations to enable your target concentration. Commercial use licenses are available.
  • Commercial supply of excipients in Emprove® Expert quality to support your clinical development and commercialization
  • Application know-how to support the selection of the most promising solution for your protein of interest

Supporting Screening for your Protein

The Viscosity Reduction Platform comprises six excipients from two functional groups, an amino acid component (L-Arginine, L-Phenylalanine, L-Ornithine monohydrochloride) and an anionic component (Benzenesulfonic acid, Pyridoxine hydrochloride, Thiamine phosphoric acid ester chloride dihydrate). These two components can act in synergy, leading to a superior viscosity reduction in many cases, compared to a single excipient, whilst maintaining protein stability.

The six excipients can be combined in up to nine functional combinations. As every protein is different, it is important to test to find your most promising combination.

Below are the options we offer to test the platform in order to find your most promising combination.

Your in-house screening (free-of-charge)
Your In-House Screening (Free-of-Charge)
  • Test kit
  • User guide
  • Technical consultancy
Screenshot of Viscosity Reduction Excipient Finder Web Application Design of Experiment Step
Excipient Finder (Free-of-Charge)

Save material and time during in-house screening with the excipient finder, a web application accessible upon request:

  • Minimizes experiments needed to find optimal solution
  • Machine learning-based model
  • No input on protein sequence or structure needed  
Feasibility testing service (fee-for-service)
Feasibility Testing Service (Fee-for-Service)

Do you have a viscosity issue but no resources to test the platform? We offer support via our Feasibility Testing Service:

  • Screen the platform with your protein of interest
  • Support in finding the most promising combination
  • Highest viscosity reduction to achieve your target concentration whilst maintaining protein stability

The Benefits of the Viscosity Reduction Platform Include:

  • 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.


Products

Sort by Relevance
Showing 1-6 of 6
Page 1 of 1
Page 1 of 1
Showing 1-6 of 6
Page 1 of 1
Page 1 of 1

Related Product Resources

Page 1 of 2

Related Videos


Related Webinars

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

Get details on the impact of viscosity-reducing excipients on protein stability and syringability.

Overcoming Viscosity Challenges in TFF
Webinar: Overcoming Viscosity Challenges in High Concentration Tangential Flow Filtration (TFF)

Get details on the impact of TFF cassette design & benefits of viscosity-reducing excipient combinations during TFF.


External Resources

Pharma’s Almanac: Enabling Stable, High-Viscosity Injectable Drug Products with New Excipient Combinations

About current issues with viscosity and injectable drugs, why viscosity has become a bigger concern today than in the past, and the approach to overcoming key limitations

Pharma's Almanac: Viscosity Reduction with An Excipient Platform and Feasibility Testing Service

About current viscosity formulation challenges, the application of the Viscosity Reduction Platform, and benefits of the Feasibility Testing Service

The Medicine Maker: High Concentration Protein Therapeutics and their Viscosity

About our scientists’ work on high concentration protein therapeutics and their viscosity, and what the solutions could mean for patients and their medicines




Sign In To Continue

To continue reading please sign in or create an account.

Don't Have An Account?