AmericanPharmaceuticalReviewDecember 02, 2021
Tag: Vaxart , GMP Manufacturing Facility , acquisition , Norovirus vaccine
Vaxart, Inc. has entered into an agreement with Kindred Bioscience, Inc. for the purchase of KindredBio’s manufacturing equipment and sublease of its GMP (Good Manufacturing Practices) manufacturing facility in Burlingame, California, giving Vaxart control of its second GMP manufacturing facility.
The transaction closed Tuesday, Nov. 30, 2021, and Vaxart expects the facility to be operational for GMP production in Q1 2022.
“This acquisition gives us greater flexibility to manage our manufacturing needs by allowing Vaxart to exercise more control over our quality contol program and the timing of our manufacturing activities,” said Andrei Floroiu, Vaxart’s Chief Executive Officer.
“Vaxart is developing not only COVID-19 oral tablet and norovirus vaccines but also oral tablet vaccines for other diseases using our proprietary delivery platform. With this second plant, we expect to have the clinical-scale manufacturing capacity necessary to rapidly develop our multiple programs in parallel,” Floroiu said.
Vaxart’s existing South San Francisco GMP manufacturing facility and the Burlingame facility will manufacture materials for Vaxart’s COVID-19 and norovirus oral vaccine tablets. Vaxart recently began a Phase II study of its COVID-19 vaccine candidate and has several Phase I studies of its norovirus vaccine candidate underway.
The Burlingame facility, which can produce biologic drug substances at up to 500L bioreactor scale, has been used by Vaxart since April 2020 to produce COVID-19 and norovirus vaccine clinical trial materials. It will also provide GMP manufacturing capacity to support the development of additional candidates in Vaxart’s vaccine portfolio.
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