FAREVA Expands Pau Site with Aseptic Pilot Facility for Liquid and Lyophilized Injectables

• FAREVA has opened a new GMP sterile pilot unit at its Pau site to support the development and aseptic production of injectable drugs.

• The unit is capable of handling liquid and lyophilized forms, with batch sizes ranging from 200 to 8,000 vials.

FAREVA has expanded its pharmaceutical development capabilities with the opening of a new GMP sterile pilot unit at its Pau site in France. The unit is designed to support the formulation and aseptic filling of both liquid and lyophilized injectable drugs, including those derived from biotechnology such as monoclonal antibodies, mRNA in LNP form, peptides, and ADCs.

The facility is equipped with a modern isolator system that meets the latest standards of the revised Annex 1 guidelines for sterile products. It allows production of materials for development studies, clinical trials, and small-scale commercial applications, including specialised products such as orphan or paediatric drugs.

Batch sizes can range from 200 to 8,000 vials. The unit is capable of handling a wide spectrum of product types and containment levels—from OEB 1 to OEB 5—and includes an aseptic bulk formulation area connected to a 2 m² lyophilizer. The setup also features an autoclave for terminal sterilisation when required and incorporates a cold chain system to ensure temperature control from Drug Substance (DS) storage to Drug Product (DP) shipment.

The new pilot unit is fully integrated with the site’s existing infrastructure, including quality assurance, engineering, environmental health and safety (EHS), logistics, visual inspection, and packaging. Analytical development services are also available to support batch release, validation, and stability studies.

With this addition, FAREVA reinforces its offering as a CDMO in sterile contract manufacturing, stating that the new infrastructure provides pharmaceutical and biotech clients with a “high-performance, secure solution fully aligned with the latest regulatory requirements.”