Vaccine Partner Valneva receives FDA approval for the World's first chikungunya vaccine using Albumedix' Recombumin®
Albumedix Ltd ('Albumedix'), now part of the life science group Sartorius, announces that Recombumin® is critical to the manufacture of the first FDA- licensed chikungunya vaccine.
- Valneva's lyophilized chikungunya vaccine IXCHIQ® is the first in the world to be FDA approved against the viral disease, addressing an unmet medical need.
- Recombumin®, a chemically defined, human and animal origin-free recombinant human albumin, is a critical enabler for the manufacture and formulation of Valneva's chikungunya vaccine.
- Recombumin® supports the stability of the vaccine and is used as an excipient in the final formulation, conferring storage and logistical benefits, supporting the global distribution of the vaccine.
NOTTINGHAM, England, Nov. 22, 2023 /CNW/ -- The FDA on 10th November 2023 announced the approval of IXCHIQ®, Valneva's vaccine against the chikungunya virus. Notably, this is the first vaccine against the mosquito-borne disease to have been granted marketing approval by the FDA.
Recombumin® recombinant human albumin is included as an excipient in the final formulation of IXCHIQ®. Recombumin® supports the stability of the vaccine, acting as a logistical enabler, conferring temperature stability benefits, permitting the global distribution of this world-first vaccine.
Responding to the announcement, Albumedix' CEO, Mr Jonas Skjødt Møller said, "Recombumin® is a multifunctional tool for the life sciences, refined through 40 years of research and development it builds upon 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 to have our product play a role in the delivery of this world first. The expansion in the number of approved vaccines and biopharmaceuticals using Recombumin® is a testament to the safety and quality of the product we produce."
About Recombumin®
A multifunctional excipient, ancillary, and raw material, Recombumin® recombinant human albumin is utilized in various pre-clinical, clinical, and marketed vaccines and biopharmaceuticals. Human and animal-origin-free, produced in cGMP facilities in the UK, from a proprietary yeast strain, Recombumin® is a consistent and high-quality albumin solution. Recombumin® not only provides developers and manufacturers with the stabilizing benefits delivered through a balance of the natural biological and physiochemical properties of albumin but amplifies these, delivering enhanced technical performance, regulatory support, and consistency as compared to other albumin sources.
About Valneva's IXCHIQ® chikungunya vaccine
In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA's accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies.
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SOURCE Albumedix, now part of Sartorius
Kyle Forster-Stringer, Global Marketing Manager, Albumedix, [email protected]
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