The agreement was announced following a successful quality audit at that facility, reported the CDMO.
As part of the deal, Recipharm will aseptically pack single-use vaccines, used to treat a severe infectious disease that affects both young children and infants.
The containers will be filled using the CDMO’s specialist blow-fill-seal (BFS) capabilities, creating products that are quick to distribute and simplifying administration for healthcare providers, it said.
Recipharm plans to recruit over 30 additional employees between 2022 and 2026 as the product scales towards commercial production.
The Stockholm, Sweden headquartered CDMO said it is investing €14m (US$15.6m) into its vaccine manufacturing offering at the French site, with a spokesperson telling BioPharma-Reporter the capital will cover a new manufacturing line - filling and packaging equipment - in a new dedicated area at the plant.
Located in the Alsace region of France, Kaysersberg is one of Recipharm’s specialist sterile manufacturing facilities. The spokesperson said the plant is now shifting its focus from the ophthalmic arena into the biologicals business.
Yves Buelens, general manager at Recipharm’s facility in Kaysersberg, said: “This deal is indicative of Recipharm’s successful and ongoing product portfolio diversification. We’ve invested heavily into new capabilities that have built on our BFS expertise and as a result, strengthened our biotech offering. We are now in a position to welcome new biopharma projects to the Kaysersberg site.”
This facility has been inspected and approved by multiple regulatory agencies across the globe including France's National Agency for the Safety of Medicines and Health Products, ANSM, the US Food and Drug Administration (US FDA) and Brazil’s health regulatory agency, ANVISA.
Recipharm said the site also holds a number of approvals for its environmental management systems and occupational health and safety management system.
Recipharm operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, and the UK.
At the start of the year it confirmed the sale of its solid dose manufacturing site at Fontaine-lès-Dijon, France to Astrea Pharma, with Marc Funk, CEO of Recipharm, saying that divestment would help strengthen the organization’s financial position, streamline its operations and consolidate its position as a top five global CDMO.
This month also saw the company offload its API production site in Newcastle in the UK to Chinese CRO, Pharmaron.