KLEPTOSE® HP & HPB BioPharma - Hydroxypropyl betacyclodextrin, low endotoxin, USP, EP

KLEPTOSE® HP & HPB BioPharma - Hydroxypropyl betacyclodextrin, low endotoxin, USP, EP
Product Description

Suitable for use in biopharmaceutical manufacturing and as an excipient for injectable dosage forms.

ROQUETTE FRERES SA

  • FR
  • 2015
    On CPHI since
  • 5000+
    Employees
Company types
Manufacturer/Innovator
Specifications
  • Selling Points
    Experienced Technicians; International Approvals/Standards; Product Features; Product Performance; Prompt Delivery; Quality Service
  • Supplied from
    France
  • Measured In
    kilogram

ROQUETTE FRERES SA

  • FR
  • 2015
    On CPHI since
  • 5000+
    Employees
Company types
Manufacturer/Innovator

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ROQUETTE FRERES SA resources (16)

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    The new facility will focus on the research of excipients for oral dosage forms, drug delivery systems, nutraceutical APIs and innovative pharma ingredients
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    Worldwide, people are increasingly health-conscious and aware of the impact of individual lifestyle choices on their health and the health of others. In the latest years, consumers seek more and more transparency from companies through their brand, product manufacturing, and actions that promote well-being for the world around them. While also looking for more affordable, accessible, and personalized product experiences. This session explores the latest news and insight on consumer health, including how pharma engages patients in education and decision-making.
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    It’s a hard pill to swallow, but medication adherence is a crucial issue today. For oral formulations in pharma and nutraceuticals, taste, appearance, and aroma directly impact patient compliance and consumer experience.
    Choosing the right excipients to provide optimum performance while continuing to appeal to patients and consumers alike is critical in bringing finished formulations to market.
  • Video Polysorbates versus Hydroxypropyl Beta-Cyclodextrin (HPBCD) Stability Comparative Study and their Monoclonal Antibody Stability Benefits

    Polysorbates are intensively used in biologics formulation as stabilizer due to their propensity to inhibit aggregation at interfaces but possess low intrinsic stability. In this study, the chemical stability of KLEPTOSE® HPBCDs are compared with polysorbates under various stress conditions.

    When subjected to heat stress and other chemical stressors – autoclave, light and oxidative stresses – HPBCD remains almost stable while polysorbates show more severe degradation. Further, profiling characterization and degradation analysis reveal that HPBCD chemical structure remains intact while polysorbates undergo significant hydrolytic degradation and oxidation.

    Lastly, the physicochemical stability of monoclonal antibody in formulations have been investigated using adalimumab as a model protein. When subjected to light stress, HPBCD-containing formulations show significant decreases in protein aggregation, as well as superior monomer and total protein recovery compared to polysorbate-containing formulations. HPBCD also reduces both agitation and thermal stress-induced protein aggregation and prevents sub-visible particle formation compared to polysorbates.


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  • Brochure Think you know Cyclodextrins?

    Unleashing the power of cyclodextrins within vaccine formulation development. HPβCD is back in the spotlight, with formulators looking again at a familiar ‘ready to go’ excipient that could be part of the solution to speed up early stage vaccine development. If you would like to know more about how cyclodextrins could form part of your program, please contact our experts. https://www.roquette.com/biopharma-low-endotoxin-hydroxypropyl-beta-cyclodextrin
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  • Video Roquette, a leading global supplier of excipients

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  • Brochure Combating Coronavirus, key role of cyclodextrins in treatment and prevention

    Roquette has recently identified that its KLEPTOSE®️ hydroxypropyl beta-cyclodextrins (HPβCD) product, a functional excipient and a specialty active pharmaceutical ingredient (API), may be effective to help the joint efforts of the scientific and pharmaceutical communities working on treating and preventing new emerging viruses such as the coronavirus. HPβCD can effectively act as a safe, enabling excipient for solubility enhancement of antiviral drugs, stability improvement of therapeutic monoclonal antibodies, and as a vaccine adjuvant. KLEPTOSE®️ is a cyclodextrin, a group of structurally related natural products formed during bacterial digestion of cellulose. Cyclodextrins have indeed been shown to be effective as solubilizing and stabilizing agents in vaccines, monoclonal antibodies and oral formulations. Moreover, cyclodextrins can potentially be used for infection containment or as virucidal agents after structural modification. The company’s new position paper speaks to the potential role of cyclodextrins, such as HPβCD, in detail: “Combating Coronavirus: Key Role of Cyclodextrins in Treatment and Prevention.”
  • Brochure KLEPTOSE® HPB-LB

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