A Synergy Of Excellence: Novavax-Mabion Partnership During Unprecedented Times Amid The Covid-19 Pandemic

By Aleksandra STASIAK, Senior Registration Dossier Specialist, Mabion S.A.

Novavax's COVID-19 vaccine, Nuvaxovid, was developed in record time with the support of Mabion, a reliable partner providing manufacturing and analytical services. The cooperation between the two companies began in March 2021, but planning started in November 2020. Despite challenges posed by the pandemic and disrupted supply chains, Novavax and Mabion successfully collaborated to secure raw materials and achieve their goals. The technology transfer project took only 30 weeks, and as a result of their successful partnership, Novavax expanded their contract with Mabion for full-scale commercial manufacturing.

Mabion's role in the manufacturing process was crucial, as they successfully completed feasibility studies and adapted their platform for the manufacturing of Novavax's vaccine antigen. The process was validated, meeting all specification criteria. Mabion also supported Novavax in manufacturing variants of the vaccine and provided logistics, storage, quality control, and regulatory support.

Novavax has praised Mabion for their commitment and contribution to the development of effective and safe vaccines. The European Medicines Agency has recommended the approval of an adapted version of the Nuvaxovid vaccine targeting the Omicron variant, following the FDA's authorization of the vaccine for emergency use and an updated version for better protection against circulating variants.

Learn how a partner with the right experience and capabilities is crucial to support accelerated GMP manufacturing and ensure novel vaccines and therapeutics receive regulatory approval.