Viscosity Reduction Platform
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.
- Test kit
- User guide
- Technical consultancy
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
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
Related Product Resources
- Tool: Risk Mitigation and Quality Requirements for Bioprocesses
Get guidance through the challenges and quality requirements of your bio-manufacturing process.
- User Guide: Experimental Procedures to Evaluate the Viscosity Reduction Platform
Review a principle procedure to prepare a low volume of a highly concentrated protein formulation to allow for viscosity measurements.
- Technical Article: Addressing Viscosity Challenges for Subcutaneous Injections
Learn about strategies for reducing the viscosity of high concentration drug formulations.
- Whitepaper: Viscosity-Reducing Excipients for Protein Formulation
Read about the effect of protein viscosity on injection force and the platform’s ability to balance viscosity reduction with protein stability
- Technical Article: Overcoming Viscosity Challenges in High Concentration Tangential Flow Filtration (TFF)
Learn how the use of viscosity-reducing excipients can improve process economics.
- Whitepaper: Viscosity-Reducing Excipients for Improvement of Filtration Processes
Read about benefits of viscosity-reducing excipients on productivity and final concentrations.
Related Videos
Related Webinars
Get details on the impact of viscosity-reducing excipients on protein stability and syringability.
Get details on the impact of TFF cassette design & benefits of viscosity-reducing excipient combinations during TFF.
External Resources
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
About current viscosity formulation challenges, the application of the Viscosity Reduction Platform, and benefits of the Feasibility Testing Service
About our scientists’ work on high concentration protein therapeutics and their viscosity, and what the solutions could mean for patients and their medicines
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