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Helping Arcturus meet supply needs for their Phase III trial by lyophilizing a self-amplifying mRNA COVID-19 vaccine candidate.

Arcturus Therapeutics is an innovator of several pharmaceutical technologies, especially those utilized for vaccine programs for COVID-19. In 2020, Arcturus engaged Recipharm to support the manufacture of clinical trial supplies of Arcturus’ COVID-19 vaccine candidate in an ongoing Phase I/II clinical trial. Further, they needed to manufacture and release more than 100,000-units of ARCT-154 mRNA vaccine finished drug product in support of clinical Phase III trial study.  

 

When Arcturus presented its mRNA vaccine candidate to Recipharm, it was at the stage of a frozen product, a ready-to-administer sterile injectable for Phase I & II clinical trials. The inherent cryogenic logistics and storage costs associated with mRNA vaccines, as well as their intended markets created an additional burden for Phase III clinical trial and commercialization. To mitigate these challenges, Recipharm collaborated with Arcturus in the technology transfer, qualification and cGMP manufacturing of the lyophilized product to ease the complexities of distribution and extension of vaccine shelf-life. 

 

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