Downstream Processing
At Roquette, we understand that every downstream process presents unique challenges — from maintaining protein integrity to ensuring regulatory compliance at scale. Our excipient solutions are designed to support viral safety, stabilization, cryoprotection, and process efficiency, giving you the flexibility to adapt to complex biopharma workflows. With cyclodextrins, polyols, and sugars available in GMP, pharmacopeia-grade quality, Roquette helps you safeguard product quality while accelerating time-to-market.
Protein Stability Solutions
Biopharmaceutical manufacturing demands ingredients that deliver safety, consistency, and performance at every stage of downstream processing. Roquette offers a comprehensive portfolio of high-quality excipients, including KLEPTOSE® HPB and HP hydroxypropyl-beta-cyclodextrin, sorbitol, mannitol, and dextrose monohydrate — specifically developed to help you overcome your toughest downstream challenges.
From enhancing protein stability and reducing aggregation, to supporting viral clearance, viscosity control, and bulk formulation robustness, our solutions are proven to safeguard product integrity and streamline scale-up. Whether protecting sensitive proteins during lyophilization and reconstitution or maintaining isotonicity in final formulations, Roquette excipients help ensure reliable, reproducible results.
Every product is GMP-manufactured and pharmacopeia-grade, backed by Roquette’s regulatory expertise, Customer Technical Services (CTS), and secure global supply chain. With Roquette as your partner, you gain not only trusted excipients but also the technical and regulatory support needed to move confidently from lab to commercial production.
Optimizing Downstream Biopharma Processes with Roquette Excipient Solutions
Viral inactivation and clearance
KLEPTOSE® HPB and HP hydroxypropyl beta-cyclodextrin are proven to enhance the performance of viral clearance steps in downstream purification. By improving solubility and facilitating the removal of impurities, they support both process safety and regulatory compliance. These excipients integrate seamlessly into validated viral inactivation protocols, helping manufacturers strengthen patient protection while meeting global regulatory expectations.
Protein stabilization and aggregation mitigation
Biologics are inherently sensitive to degradation and aggregation. Roquette’s excipients provide a stabilizing environment that helps preserve protein conformation, reduce aggregation, and maintain bioactivity. This protection is critical for extending shelf life, enabling smoother purification, and ensuring consistent therapeutic performance from clinical batches through to commercial scale.
Flexible excipient options
With a broad portfolio spanning cyclodextrins, mannitol, sorbitol, and dextrose monohydrate, Roquette gives manufacturers the flexibility to select the right excipient for the right application. Whether the goal is bulking, cryoprotection, viscosity reduction, or isotonicity adjustment, our solutions can be tailored to address a wide range of downstream challenges without compromising safety or quality.
Lyophilization and reconstitution
Freeze-drying is essential for stabilizing many biologics, but it introduces risks of protein loss or poor cake structure. Roquette’s polyols and sugars, particularly mannitol and sorbitol, act as reliable bulking agents and cryoprotectants, delivering robust cake formation and predictable reconstitution. These excipients help ensure product integrity during storage and transport, supporting a smoother path to commercialization.
Process compatibility
Our excipients are designed for seamless integration into purification workflows, offering compatibility with existing chromatography and filtration steps. When required, they can be readily removed or exchanged, supporting regulatory expectations for process validation while minimizing risk of downstream interference. This makes Roquette excipients highly versatile tools for both clinical development and large-scale manufacturing.
Regulatory compliance and global support
Every excipient is produced to GMP standards and aligned with major pharmacopeias (EP, USP, JP), giving you confidence in quality and global acceptance. Beyond supply, Roquette’s Customer Technical Services (CTS) and regulatory experts partner with you throughout development, from dossier preparation and stability studies to global submissions. With this support, you gain both the technical edge and regulatory clarity needed to bring therapies to market efficiently.
Our Services and Expertise
Roquette provides more than just high-quality excipients — we deliver end-to-end support for your downstream bioprocessing needs. All products are GMP-manufactured and pharmacopeia-grade, with low endotoxin levels and full traceability to ensure consistent quality and regulatory compliance.
Our Customer Technical Services (CTS) team works closely with you to provide hands-on guidance, process development support, and troubleshooting at every stage, from lab-scale experiments to large-scale production.
In addition, Roquette offers regulatory expertise to help streamline submissions and validation across global markets, ensuring your processes meet the most demanding requirements.
Combined with our robust supply chain, these services provide reliable access to critical ingredients and the technical support needed to keep your manufacturing processes running smoothly.
Key Excipient Solutions for Downstream Bioprocessing
Roquette offers a carefully selected portfolio of excipients designed to support protein stability, viral clearance, and formulation robustness throughout downstream processing. Each product is manufactured to GMP and pharmacopeia-grade standards and is supported by technical and regulatory expertise.
Our Applications
Biologics
Stabilizers, cryoprotectants, and process aids for safe, efficient biologic formulation and manufacturing.
Injectables, Dialysis and APIs
High-purity excipients ensuring biocompatibility and isotonicity in parenteral and dialysis applications.
Oral Dosage Solutions
Functional excipients improving flow, compressibility, solubility, and taste for tablets and capsules.