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Lucy Chard
16 May 2023

Recipharm receives approval for the manufacture of a new microbiome-based therapeutic

Recipharm receives regulatory approval for the manufacture of a microbiome-based product for the prevention of Clostridioides difficile recurrent infection, under GenIbet Biopharmaceuticals and Seres Therapeutics. 

The leading CDMO in biopharmaceuticals Recipharm has received approval from the US FDA for its auxiliary partner GenIbet Biopharmaceuticals to manufacture its orally-administered fecal microbiota product, VOWST. 

VOWST is used to prevent Clostridioides difficile recurrent infection (CDI) in adults who have already received antibacterial treatment for the infection. CDI is one of the biggest microbial health risks in the USA according to the Centers for Disease Control and Prevention, responsible for around 30,000 deaths each year. 

Recipharm will oversee the manufacturing of the microbiota product at the GenIbet site in Oeiras, Portugal, in tandem with Seres Therapeutics.

Raquel Fortunato, CEO of GenIbet, commented: 

“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.”

Under Recipharm, GenIbet Biopharmaceuticals is experienced in manufacturing of biological clinical trial material, viral vectors, RNA, and microbiome therapeutics in particular. In 2014 GenIbet began supporting Seres Therapeutics, specialising in clinical trial supply, process validation, and BLA submission, from there they progressed to enabling the VOWST Tech Transfer and taking over the GMP manufacturing of the product. 
GenIbet Biopharmaceuticals is known for developing novel production processes in the preclinical and Phase I and II clinical trial stages. 

The recent FDA approval will mean that Recipharm can expand its manufacturing capabilities and increase the output of novel modalities for manufacturing biologics. 

Mentioned Companies
Recipharm AB
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Lucy Chard
Digital Editor - Pharma

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