Stabilization of Biologics
Supported by Roquette’s scientific expertise and regulatory guidance, hydroxypropyl beta-cyclodextrin (HPβCD) excipients help biopharma developers overcome formulation instability and extend the shelf life of biologics from early-stage development through commercial manufacturing. With our vertically-integrated, fully traceable supply chain and decades of formulation experience, Roquette can help you bring biologics to life – confidently.
Stabilize Monoclonal Antibody Formulations with Hydroxypropyl Beta-Cyclodextrin
KLEPTOSE® HPB and HP hydroxypropyl beta-cyclodextrin (HPβCD) excipients deliver advanced biologics stabilization for monoclonal antibody (mAb) formulations. Developed to address the limitations of traditional surfactants, these excipients enhance protein stability for monoclonal antibodies while reducing the risk of aggregation and particle formation caused by stress factors such as heat, light, or agitation.
Unlike conventional polysorbates that can degrade over time, KLEPTOSE® HPβCD provides high physical and chemical stability under challenging conditions, preserving the integrity and efficacy of sensitive biologics. Its non-ionic and pH-neutral profile, combined with low viscosity, high solubility, and low osmolality, ensures predictable performance in a wide range of formulation environments.
These excipients can be used independently or in combination with polysorbates to achieve optimal mAb formulation stability and product quality. Supported by Roquette’s scientific expertise and regulatory guidance, KLEPTOSE® HPβCD excipients help biopharma developers overcome formulation instability and extend the shelf life of biologics from early-stage development through commercial manufacturing.
Innovative HPβCD Excipients for Enhanced mAb Stability and Regulatory Compliance
Roquette’s hydroxypropyl beta-cyclodextrin (HPβCD) excipients provide innovative solutions to the most common challenges in mAb formulation stability. By improving the physical and chemical protection of proteins, these excipients help developers achieve more robust, reliable biologic formulations that meet regulatory and performance standards.
Preventing Aggregation and Particle Formation
KLEPTOSE® HPβCD excipients reduce aggregation and particle formation caused by stressors such as heat, light, and agitation. Their stable molecular structure shields biologic actives from destabilizing interactions, maintaining consistent product quality across processing and storage conditions.
Mitigating Polysorbate Degradation
By replacing or complementing traditional polysorbates, KLEPTOSE® HPβCD addresses the degradation and oxidation issues that can compromise formulation integrity. The excipients maintain surfactant performance without contributing to particulate generation or instability.
Enhancing Biologic Stability and Shelf Life
Hydroxypropyl beta-cyclodextrin excipients improve overall mAb formulation stability, extending shelf life and preserving therapeutic efficacy. Their resistance to environmental stress supports safer, more predictable biologic performance during long-term storage and transport.
Supporting Regulatory Compliance and Process Reliability
Compliant with USP and EP pharmacopeia standards and manufactured under good manufacturing practice (GMP) conditions, KLEPTOSE® HPβCD excipients support process reliability and global regulatory acceptance. Their consistent quality facilitates scale-up from development to commercial manufacturing.
Roquette Expertise
Roquette offers a comprehensive support framework to help biopharma partners achieve reliable, compliant, and high-performing mAb formulation stability. Through an integrated combination of technical expertise, regulatory guidance, and collaborative problem-solving, Roquette ensures that each project moves efficiently from development through commercialization.
At the core of this approach is Customer Technical Services (CTS), a dedicated team of scientists and formulation specialists who partner directly with customers to address formulation challenges, optimize process conditions, and accelerate development timelines. CTS provides practical insight into excipient functionality, compatibility, and performance under real-world manufacturing conditions, enabling more informed formulation design decisions.
Roquette also provides extensive formulation expertise and regulatory documentation, supporting customers through each stage of biologics development. This includes guidance on meeting USP and EP pharmacopeia standards and maintaining full GMP compliance. By combining technical data with regulatory clarity, Roquette helps developers streamline qualification, validation, and scale-up processes while ensuring confidence in global regulatory acceptance.
Complementing this expertise, Roquette’s knowledge base includes technical data and scientific resources, such as whitepapers and technical datasheets, offering evidence-based insights into hydroxypropyl beta-cyclodextrin excipients for biologics stabilization. Together, these services and resources empower teams to make data-driven formulation decisions that enhance stability, consistency, and long-term biologic quality.
Tailored Hydroxypropyl Beta-Cyclodextrin Excipients for Biologics Stabilization
Roquette’s KLEPTOSE® hydroxypropyl beta-cyclodextrin product range offers high-performance excipients designed to support aggregation prevention in biologics and enhance protein stability for monoclonal antibodies.
KLEPTOSE® HPB hydroxypropyl beta-cyclodextrin
KLEPTOSE® HPB hydroxypropyl beta-cyclodextrin is an excipient designed for advanced biologic stabilization. It enhances formulation performance by resisting environmental stresses, reducing aggregation, and maintaining mAb structural integrity. KLEPTOSE® HPB is well suited for formulations where minimizing stress-induced degradation is a critical priority.
KLEPTOSE® HP hydroxypropyl beta-cyclodextrin
KLEPTOSE® HP hydroxypropyl beta-cyclodextrin provides similar stabilization benefits while offering greater flexibility in formulation design. It can be selected when moderate stabilization and formulation adaptability are needed, making it ideal for early-stage development, feasibility studies, or applications requiring fine-tuning of viscosity and solubility profiles.
Solve your challenges
Biologic Challenges
Specialized excipients to enhance biologic stability, viscosity control, and process efficiency.
Viral Inactivation for Viral Clearance
Support viral safety with excipients that aid effective inactivation steps.
Viscosity Reduction for Protein Formulations
Enhance processability and enable high-dose delivery through viscosity control.