KLEPTOSE®
Low endotoxin hydroxypropyl beta-cyclodextrin
Available in 1, 10 and 25kg plastic drums, and Roquette Precision Dispense packaging
KLEPTOSE® HP and HPB BioPharma Low endotoxin hydroxypropyl beta-cyclodextrin is a multifunctional excipient that provides protein stabilization in biopharmaceutical downstream applications. These are cyclic oligosaccharides with a bucket-like structure. With a hydrophobic internal cavity and hydrophilic exterior, these starch derivatives can encapsulate molecules, forming inclusion complexes where lipophilic compounds are non-covalently bound within the cavity.Their unique function to encapsulate and shield water insoluble materials can be utilized to shield exposed hydrophobic residues on aggregation-prone proteins, thereby modulating protein aggregation. Widely used in the formulation of small molecules, highly soluble beta-cyclodextrin derivatives like our KLEPTOSE® HP BioPharma and KLEPTOSE® HPB BioPharma show promise as a multifunctional excipient suitable for biopharma applications.
Representing a promising class of excipients that can reduce protein aggregation induced by physical stress, cyclodextrins can serve as an alternative option to currently used excipients, or a tool to synergistically complement your biotherapeutic formulations.
These materials are suitable for use in biopharmaceutical manufacturing and as an excipient for injectable dosage forms. Contact us today at Roquette to talk to us about these multicompendial materials - EP, USP and JP.
® Registered trademark(s) of Roquette Frères
Innovative new solution for protein stabilization
Multi-compendial
Sole custody of the supply chain
Applications
- Downstream
- Single-use Manufacturing
Functional Properties
- Protein Stabilization
- Precision Dispense
Other Properties and Benefits
- Freely soluble in water
- Freely soluble in propylene glycol
- White or almost white powder
- Amorphous or crystalline powder
Documents & Samples
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Product Types
KLEPTOSE® HP BIOPHARMA - #346105
Key attributes:
Very high purity, Low endotoxin, For application in BioPharma
Unfortunately this product is not available for sampling
Higher level of molecular substitution (MS) = 0.90
KLEPTOSE® HPB BIOPHARMA - #346113
Key attributes:
Very high purity, Low endotoxin, For application in BioPharma
Unfortunately this product is not available for sampling
Lower level of molecular substitution (MS) = 0.62
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Regulation & Compliance
Registrations may vary depending on local regulations
Compliance
- European Pharmacopoeia
- United States Pharmacopeia
- Japanese Pharmacopoeia
Regulatory
- Manufacture: ICH-Q7 or IPEC PQG GMP - Production and packaging
- Distribution: IPEC Good Distribution Practices
- Registrations vary depending on local regulations.
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