FDA nod for new microbiome-based therapeutic VOWST production at Recipharm site

2 May 2023

Swedish contract development and manufacturing organization (CDMO) today announced that its subsidiary, GenIbet Biopharmaceuticals, has been approved by the US Food and Drug Administration (FDA) as a manufacturing site of VOWST (fecal microbiota spores, live-brpk), formerly called SER-109, a breakthrough orally-administered fecal microbiota product for the prevention of Clostridioides difficile recurrent infection (CDI) in adults following antibacterial treatment for recurrent CDI.

Recipharm will produce VOWST at its GenIbet site in Oeiras, Portugal, on behalf of US microbiome company Seres Therapeutics (Nasdaq: MCRB), which gained US regulatory approval for the product late last month, and expects VOWST to be available in the USA in June.

A Recipharm company, GenIbet specializes in the manufacture of biological clinical trial material and novel modalities such as viral vectors, RNA and microbiome therapeutics.

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