Recipharm, a global contract development and manufacturing organization (CDMO), announced that its subsidiary, GenIbet Biopharmaceuticals, has received U.S. FDA approval as a manufacturing site of VOWST, 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 manufacture VOWST at its GenIbet site in Oeiras, Portugal on behalf of Seres Therapeutics.

In the U.S., CDI has been classified as one of the greatest microbial threats to human health by the Centers for Disease Control and Prevention (CDC) and is associated with approximately 30,000 deaths annually.

GenIbet specializes in the manufacture of biological clinical trial material and novel modalities such as viral vectors, RNA and microbiome therapeutics. GenIbet started working on the VOWST Tech Transfer and GMP manufacturing in 2014, supporting Seres Therapeutics throughout the clinical trial supply, process validation and BLA submission. GenIbet currently supports customer projects in the preclinical and Phase 1/2 stages and has a track record of developing novel production processes.

The decision by the FDA will provide Recipharm with a platform on which to build out its manufacturing capabilities for new modalities in the Biologics space.

Seres Therapeutics is a commercial-stage biotech working to revolutionize a wide range of diseases by modulating the function of the human microbiome.

Raquel Fortunato, CEO of GenIbet, said: “FDA’s approval is a major development in the biologics market. It will help shift the perception of microbiome medicines and open the door for new opportunities for patients around the world. I would like to thank colleagues, past and present, who have been involved in the VOWST project. Their hard work and perseverance over almost ten years have enabled this major milestone which has the potential to improve patients’ health and save lives. I can’t think of a better example to illustrate our mission, to be the bridge between innovators and patients.”