Fareva announced the opening of a new GMP Pilot Unit at its Pau site dedicated to the production of liquid and lyophilized injectable forms.
With its new isolator, Fareva now offers development services for formulation and aseptic filling of both liquid and lyophilized forms. This new production capability supports development studies, clinical trial batch production, and even the manufacturing of small commercial batches (e.g., pediatric or orphan drugs).The equipment complies with the latest requirements of the new Annex 1 for sterile products. It enables the manufacturing of biotech-derived medicines, such as monoclonal antibodies, mRNA in LNP form, proteins, peptides, recombinant proteins, and ADCs, supporting Phase 1 to Phase 3 studies, and scaling up to commercialization through Fareva’s industrial network (5sterile production sites).
Batch size is flexible, ranging from 200 to 8,000 vials depending on requirements, with the possibility of using single-use systems. The isolator allows handling a broad spectrum of products, from small molecules classified OEB 1 to highly potent substances up to OEB 5, for which the Pau site has over 30 years of experience. This unit includes an aseptic preparation area for bulk formulation, which is filled into vials via an aseptic line connected under laminar flow to a 2m² lyophilizer, in accordance with Annex 1.An autoclave is also available for products requiring terminal sterilization.
Fareva PAU features an integrated cold chain system , meeting stringent temperature monitoring standards throughout every stage of the manufacturing cycle. This ensures optimal preservation conditions for the most sensitive products, including storage of Drug Substances (DS), maintaining formulations at required temperatures before filling, and preserving Drug Products (DP) until shipment. The pilot unit benefits from the full support of Pau site’s existing infrastructure, including Quality Assurance, EHS, Engineering, Logistics (procurement, cold chain), inspection (mirage), and packaging.