– Vaccine Partner Valneva Receives FDA Approval for World’s First Chikungunya Vaccine Using Albumedix’s Recombumin®
Albumedix Ltd (‘Albumedix’), now part of the Sartorius life sciences group, announces that Recombumin® is instrumental in the manufacture of the first FDA-cleared chikungunya vaccine
NOTTINGHAM, England, Nov. 22, 2023 /PRNewswire/ — On November 10, 2023, the FDA announced the approval of IXCHIQ®, Valneva’s vaccine against chikungunya virus. This is the first vaccine against this mosquito-borne disease whose marketing is approved by the FDA.
Recombumin® recombinant human albumin is included as an excipient in the final formulation of IXCHIQ®. Recombumin® favors the stability of the vaccine, acting as a logistical facilitator, conferring benefits of temperature stability, allowing the global distribution of this pioneering vaccine in the world.
Responding to the announcement, Albumedix CEO Jonas Skjødt Møller said: “Recombumin® is a multifunctional tool for life sciences, perfected over 40 years of research and development, which is based on the natural qualities of human albumin. In this application, as an excipient in the final formulation, Recombumin® benefits the logistics associated with the product. We are, therefore, exceptionally proud that our product plays a role in delivering this world first. The increase in number of approved vaccines and biopharmaceutical products using Recombumin® is a testament to the safety and quality of the product we manufacture.”
About Recombumin®A multifunctional excipient, auxiliary and raw material, Recombumin® recombinant human albumin is used in various preclinical, clinical and marketed vaccines and biopharmaceutical products. Free of human or animal origin, produced in cGMP facilities in the UK, from a proprietary yeast strain, Recombumin® is a high quality, consistent albumin solution. Recombumin® not only provides developers and manufacturers with the stabilizing benefits of balancing the natural biological and physicochemical properties of albumin, but it amplifies them, offering greater technical performance, regulatory support and consistency compared to other albumin sources. .
About Valneva IXCHIQ® Chikungunya VaccineIn the United States, IXCHIQ® is a live attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in persons 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under the FDA’s accelerated approval pathway, continued approval for this indication is dependent on verification and description of clinical benefit in confirmatory studies.
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