New classes of biotherapeutics bring new formulation challenges. Rely on Roquette to deliver solutions that resolve protein stability challenges impacting your biopharmaceutical development.
Protein stability solutions
Revolutionary ideas. Real results. Rely on Roquette for biopharmaceutical solutions expertly designed to resolve protein stability challenges.
Complete downstream processing ingredients
Roquette’s protein stabilizing agents feature contaminant-free excipients produced in state-of-the-art manufacturing facilities in accordance with US FDA and ICH Q7 GMP quality guidelines.
Anchored by research-led technical expertise, our biopharma product portfolio offers an unmatched range of solutions to enhance the stability of therapeutic proteins.
In short, we deliver reliable material performance that manufacturers trust.
- PEARLITOL® BioPharma mannitol: Low-endotoxin, multi-compendial grade mannitol specially designed for biopharmaceutical applications.
- NEOSORB® BioPharma sorbitol: Multi-compendial grade sorbitol with low lipopolysaccharide (endotoxin) levels for use in biopharmaceutical process development.
KLEPTOSE® BioPharma: Your complete downstream processing and final formulation solution
In biologic drug development, stability is essential.
Whether during downstream processing or the formulation stage, biopharmaceutical actives encounter a range of stresses which can affect the success of the final product.
Operations like column chromatography, ultrafiltration/diafiltration (UF/DF) and nanofiltration all have the potential to induce protein aggregation and precipitation,
Jeopardizing drug safety and efficacy. And the dangers don’t end once the drug leaves the processing plant. Exposure to extreme temperatures, light, oxygen and mechanical stresses during transport and storage can equally compromise the quality of biologic formulations.
In the face of these challenges, drug producers need a versatile, reliable excipient solution, built for stability enhancement.
Our multifunctional, highly-soluble hydroxypropyl β-cyclodextrin (HPβCD) solution, KLEPTOSE® BioPharma is here to offer the answer, supporting better biologic drug production from downstream processing techniques through to final formulation strategies.
Downstream processing
- Complete process compatibility
- Full filterability on PES, and PVDF membranes
- Suitable for sterile filtration, nanofiltration, and UF/DF
- Effectively reduces protein aggregation and visible/sub-visible particle formation during UF/DF process
Final formulation
- Superior excipient stability (compared with use of polysorbates)
- Effectively reduces stress-induced particle formation and protein aggregation in formulations, thereby extending product shelf life
- Reduces protein-protein interactions through a unique protection mechanism, including weak surface activity and preferential exclusion
The bioLOGICAL choice for protein stability
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KLEPTOSE® BIOPHARMA as a potential functional alternative to surfactants within biologic formulations. -
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We deliver the trusted ingredients manufactuers need now, and the cutting-edge science that will shape the future of biopharmaceuticals.Read press release
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Precision Dispense
We help you make safe, productive, efficient bioprocessing technology a reality. And accelerate your drug product's journey to market!
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