Viscosity Reduction for High Concentration Protein Formulations
Roquette provides excipients and formulation expertise specifically designed for protein formulation viscosity management and reducing viscosity in protein therapeutics, enabling manufacturers to produce high-concentration formulations that remain stable, bioactive, and suitable for patient-friendly administration.
Solutions for High Concentration Protein Formulations: Viscosity Reduction
High concentration protein formulations, such as monoclonal antibodies, often face challenges related to increased viscosity, which can complicate manufacturing, handling, and delivery. High viscosity may lead to difficulties in processing, increased risk of aggregation, and limitations on achievable protein concentration.
Roquette provides excipients and formulation expertise specifically designed for protein formulation viscosity management and reducing viscosity in protein therapeutics, enabling manufacturers to produce high-concentration formulations that remain stable, bioactive, and suitable for patient-friendly administration. Innovative excipients, including specialized cyclodextrins for protein formulations such as KLEPTOSE® HPB Biopharma and HP Biopharma hydroxypropyl beta-cyclodextrin, play a central role in managing viscosity while supporting protein stability.
By combining these excipients with Roquette’s technical collaboration and guidance, manufacturers can address formulation challenges efficiently, improve manufacturability, and ensure higher dose delivery with reduced injection volume. These solutions are backed by Roquette’s expertise in excipients for protein stability, helping accelerate development timelines for high-concentration protein therapeutics.
Roquette’s Viscosity Reduction Solutions
Roquette’s viscosity reduction solutions help biopharma manufacturers overcome key formulation challenges associated with high-concentration protein therapeutics. By reducing formulation viscosity, these solutions improve manufacturability, facilitate high-dose delivery, and enhance patient comfort, all while maintaining protein stability.
Viscosity Reduction Strategies
Roquette’s excipients are designed to reduce the viscosity of high-concentration protein formulations, enabling the production of more concentrated therapeutics without compromising ease of administration. This reduction in viscosity allows for smaller injection volumes or the use of thinner needles, making high-dose therapies more convenient and comfortable for patients.
Protein Stability Maintenance
In addition to lowering viscosity, Roquette’s solutions ensure that proteins remain stable and bioactive throughout formulation, handling, and administration. By minimizing aggregation, denaturation, or other destabilizing effects, these excipients help maintain the therapeutic efficacy of monoclonal antibodies and other high-concentration protein products.
Alternatives to Traditional Excipients
Roquette offers alternatives to conventional viscosity-reducing excipients, providing options that minimize the risk of unwanted interactions between the excipient and protein. These specialized solutions support safer and more predictable formulation outcomes, particularly in challenging high-concentration therapeutic applications.
Regulatory and Scale-Up Support
Roquette’s viscosity reduction strategies are designed to support regulatory compliance and scalability for commercial production. By providing comprehensive documentation, formulation guidance, and collaboration with technical experts, Roquette helps manufacturers navigate the regulatory landscape and streamline scale-up processes for high-concentration protein formulations.
Our Services and Expertise
Roquette works closely with manufacturers to develop customized viscosity reduction strategies that optimize high-concentration protein formulations. By combining formulation innovation with technical collaboration through Customer Technical Services (CTS), Roquette provides on-demand guidance, expert insights, and access to data that help solve complex formulation challenges efficiently. This integrated approach ensures that Roquette excipients for protein stability are applied effectively to maintain protein bioactivity while achieving desired viscosity reduction.
In addition to scientific support, Roquette provides comprehensive regulatory documentation to help manufacturers meet global compliance requirements. Its excipients are suitable for use in major pharmacopeias, including USP and EP, supporting smooth regulatory submissions and scalable commercial production of high-concentration protein therapeutics.
Sustainability is also a key part of Roquette’s approach. All excipients are ethically sourced and manufactured to high-quality standards, reflecting a commitment to environmentally responsible practices and sustainable supply chains across the product portfolio.
Hydroxypropyl beta-cyclodextrins for Protein Formulation Viscosity Management
Roquette offers specialized cyclodextrins for protein formulations suitable for reducing viscosity and stabilizing high-concentration protein formulations. KLEPTOSE® HP Biopharma and HPB Biopharma hydroxypropyl beta-cyclodextrin have been demonstrated to lower viscosity while supporting protein stability, providing flexible options to meet different formulation needs.
KLEPTOSE® HPB Biopharma hydroxypropyl beta-cyclodextrin
KLEPTOSE® HPB Biopharma hydroxypropyl beta-cyclodextrin effectively reduces viscosity in high-concentration protein formulations while maintaining protein stability. This grade is suitable when stronger viscosity reduction is required.
KLEPTOSE® HP Biopharma hydroxypropyl beta-cyclodextrin
KLEPTOSE® HP Biopharma hydroxypropyl beta-cyclodextrin supports viscosity management and protein stabilization in concentrated formulations. This grade may be preferred when a milder viscosity reduction is sufficient or when minimal protein interaction is desired.
Solve your challenges
Biologic Challenges
Specialized excipients to enhance biologic stability, viscosity control, and process efficiency.
Stabilization of Biologics
Maintain protein integrity with excipients that prevent aggregation and denaturation.
Viral Inactivation for Viral Clearance
Support viral safety with excipients that aid effective inactivation steps.