Viral Inactivation for Viral Clearance
In biopharmaceutical manufacturing, ensuring viral safety without compromising product integrity is critical. Traditional solvent/detergent viral inactivation methods, while effective, can introduce challenges such as toxicity, foaming, viscosity increase, and environmental or regulatory concerns. Learn more about how our solutions can help you overcome these challenges
Efficient Viral Inactivation with KLEPTOSE® HPB and HP HPBCD
Roquette’s KLEPTOSE® HPB Biopharma and KLEPTOSE® HP Biopharma hydroxypropyl beta-cyclodextrin (HPBCD) offer a high-performance, regulatory-compliant alternative designed to simplify processes while maintaining protein quality. These versatile excipients form inclusion complexes that enhance solubility, stability, and viral clearance—validated in studies against models such as X-MuLV and HSV-1.
By enabling efficient viral inactivation without affecting protein structure or downstream purification, KLEPTOSE® HPB Biopharma and HP Biopharma deliver robust viral safety across mAbs, plasma-derived products, and viral vectors. Backed by Roquette’s expertise in analytics, regulatory compliance, and GMP-grade consistency, they represent a modern, sustainable approach to bioprocess viral control.
Efficient and Safe Viral Inactivation in Bioprocessing with HPβCD Excipients
Roquette’s approach to viral inactivation in bioprocessing centers on combining process performance with biopharmaceutical safety. By leveraging the inclusion complex–forming capabilities of KLEPTOSE® HPB Biopharma and HP Biopharma hydroxypropyl beta-cyclodextrin, these solutions enable consistent viral clearance without altering protein structure or impacting purification. Designed for flexibility, they integrate smoothly into existing unit operations for monoclonal antibodies, plasma-derived therapeutics, and viral vector platforms, enhancing process robustness while meeting stringent regulatory expectations.
Reliable Viral Clearance Performance
Validated in viral clearance studies, KLEPTOSE® HPB Biopharma and HP Biopharma deliver strong log reduction values against enveloped model viruses such as X-MuLV and HSV-1. Their mechanism, based on selective inclusion complex formation, provides efficient hydroxypropyl beta-cyclodextrin viral inactivation without the need for solvent or detergent systems. This ensures reliable viral safety that aligns with modern cGMP expectations and simplifies validation across biologics manufacturing processes.
Preserving Protein Stability and Process Integrity
Unlike traditional solvent/detergent methods, hydroxypropyl beta-cyclodextrins maintain native protein conformation and activity, supporting long-term protein stabilization and consistent bioefficacy. Their low viscosity and non-foaming profile make them compatible with advanced production environments, from fed-batch systems to continuous bioprocessing, delivering stability and reproducibility.
Streamlined Operations and Sustainable Performance
The use of KLEPTOSE® HPB Biopharma and HP Biopharma hydroxypropyl beta-cyclodextrin simplifies viral inactivation workflows by eliminating solvent-handling steps, reducing waste generation, and minimizing the need for extensive post-treatment purification. Their easy removal during filtration and chromatography shortens process cycles and minimizes environmental impact. The result is a safer, cleaner, and more efficient viral inactivation workflow that aligns with sustainability objectives in modern biopharma manufacturing.
Our Services and Expertise
Roquette provides comprehensive scientific and regulatory support to help biopharma partners integrate KLEPTOSE® HPB Biopharma and HP Biopharma hydroxypropyl beta-cyclodextrin seamlessly into their viral inactivation workflows. Each grade is GMP-manufactured and produced to pharmacopeia standards (USP, EP), ensuring consistent quality, global compliance, and secure supply. To support process validation, Roquette offers low endotoxin content verification and residual analytics, delivering the detailed documentation required for viral safety and regulatory submissions.
Customers also benefit from Roquette’s Customer Technical Services (CTS) team, who collaborate closely with development and manufacturing groups to ensure successful scale-up, troubleshooting, and process optimization. In partnership with Roquette’s technical developers, process engineers, and regulatory specialists, CTS provides end-to-end guidance to adapt cyclodextrin-based inactivation methods into existing bioprocesses efficiently.
Through our scientific resources, Roquette extends this expertise into a digital environment—offering access to scientific white papers, analytical insights, and data-driven support. Together, these capabilities reflect Roquette’s commitment to enabling safe, efficient, and compliant biopharmaceutical manufacturing through innovative excipient solutions and expert partnership
Validated hydroxypropyl beta-cyclodextrins for viral safety and protein stability
Roquette’s biopharma offerings are low-endotoxin, GMP-manufactured grades of hydroxypropyl beta-cyclodextrin specifically designed for viral clearance in bioprocessing and protein stabilization. These excipients offer pharmacopeia-grade quality (USP/EP) and batch-to-batch consistency, enabling manufacturers to meet stringent viral safety and regulatory standards. Each grade provides distinct performance advantages suited to the demands of modern biopharmaceutical production.
KLEPTOSE® HPB Biopharma hydroxypropyl beta-cyclodextrin
KLEPTOSE® HPB Biopharma hydroxypropyl beta-cyclodextrin is a low molar substitution (MS) option with a nominal molecular weight of 1387 g/mol. Its inclusion complex–forming ability enables efficient viral inactivation while maintaining protein conformation and biological activity. KLEPTOSE® HPB Biopharma’s lower substitution level provides excellent solubility and compatibility with sensitive protein systems, making it ideal for monoclonal antibody and plasma-derived product manufacturing.
KLEPTOSE® HP Biopharma hydroxypropyl beta-cyclodextrin
KLEPTOSE® HP Biopharma hydroxypropyl beta-cyclodextrin features a slightly higher molar substitution and nominal molecular weight of 1501 g/mol, providing enhanced complexation capacity and viral envelope disruption. Validated in viral clearance studies for monoclonal antibodies, KLEPTOSE® HP Biopharma demonstrates strong log reduction values against enveloped model viruses such as X-MuLV and HSV-1. Its robust performance and broad process compatibility make it a preferred choice for high-throughput bioprocesses and viral vector platforms.
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.
Viscosity Reduction for Protein Formulations
Enhance processability and enable high-dose delivery through viscosity control.