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KLEPTOSE®

Low endotoxin hydroxypropyl beta-cyclodextrin

Roquette offers two hydroxypropyl betacyclodextrin, low endotoxin grade materials that provide protein stabilization for your 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 betacyclodextrin 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 Freres
    Innovative new solution for protein stabilization
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    Multi-compendial
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    Sole custody of the supply chain
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    Applications

    • Downstream

    Functional Properties

    • Protein stabilization

    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: Kleptose® BioPharma with a higher level of molecular substitution. MS = 0.90
    Attribute Regulation
    cGMP ICH-Q7 or IPEC PQG GMP*
    Supply Chain Integrity / Transparency IPEC Good Distribution Practices Guide for Pharmaceutical Excipients.
    Aflatoxins (EC) No 1881/2006
    Allergens (EC) No 1169/2011
    Conflict minerals Section 1502 of the U.S. Dodd-Frank Act**
    Dioxin (EC) No 1881/2006, (EU) No 1259/2011
    Elemental Impurities ICHQ3D
    Genotoxic Impurities ICHM7***
    GMO (EC) No 1829/2003, (EC) No 1830/2003
    Metal Catalysts EMEA/CHMP/SWP/4446/2000
    Nanoparticles (EC) No 1169/2011**
    Pesticides (EC) No 396/2005
    Residual Solvents ICHQ3C***
    Attribute Other Requirements
    Animal Origin No TSE/BSE**
    Ethylene Oxide **
    Ionizing Radiation **
    Latex ****
    Melamine ***
    Viral Safety **

    *Depending on the product
    **Not used in the manufacturing process
    ***Neither used nor generated in the manufacturing process
    ***Not generated in the manufacturing process

    KLEPTOSE® HPB BIOPHARMA - #346113

    Key attributes: Kleptose® BioPharma with a lower level of molecular substitution. MS = 0.62
    Attribute Regulation
    cGMP ICH-Q7 or IPEC PQG GMP*
    Supply Chain Integrity / Transparency IPEC Good Distribution Practices Guide for Pharmaceutical Excipients.
    Aflatoxins (EC) No 1881/2006
    Allergens (EC) No 1169/2011
    Conflict minerals Section 1502 of the U.S. Dodd-Frank Act**
    Dioxin (EC) No 1881/2006, (EU) No 1259/2011
    Elemental Impurities ICHQ3D
    Genotoxic Impurities ICHM7***
    GMO (EC) No 1829/2003, (EC) No 1830/2003
    Metal Catalysts EMEA/CHMP/SWP/4446/2000
    Nanoparticles (EC) No 1169/2011**
    Pesticides (EC) No 396/2005
    Residual Solvents ICHQ3C***
    Attribute Other Requirements
    Animal Origin No TSE/BSE**
    Ethylene Oxide **
    Ionizing Radiation **
    Latex ****
    Melamine ***
    Viral Safety **

    *Depending on the product
    **Not used in the manufacturing process
    ***Neither used nor generated in the manufacturing process
    ***Not generated in the manufacturing process

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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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    In accordance with its online legal notice, Roquette may use data you have provided. In accordance with the laws and regulations in force, you have the right to access, rectify, modify and delete personal information that you have communicated to us. By supplying your contact information, you authorize Roquette to contact you (via email, phone and/or mail) about Roquette, its products and services. You have the opportunity to opt out of future communications. To exercise your rights, please fill the form available on Data Protection page. For more information, please write to: [email protected] or at: Roquette, Corporate Legal Jennifer Godin, Data Protection Officer, rue de la Haute Loge, 62080 Lestrem Cedex France.
    Entering your details below will send your query to the relevant team for a swift and helpful response. We will not use your details for anything other than replying to your query.
    Products Details
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    Please choose "Not applicable" if your country is neither USA nor Mexico
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    In accordance with its online legal notice, Roquette may use data you have provided. In accordance with the laws and regulations in force, you have the right to access, rectify, modify and delete personal information that you have communicated to us. By supplying your contact information, you authorize Roquette to contact you (via email, phone and/or mail) about Roquette, its products and services. You have the opportunity to opt out of future communications. To exercise your rights, please fill the form available on Data Protection page. For more information, please write to: [email protected] or at: Roquette, Corporate Legal Jennifer Godin, Data Protection Officer, rue de la Haute Loge, 62080 Lestrem Cedex France.
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