Fareva has opened a new GMP sterile pilot unit at its Pau site in France, expanding the company's capabilities to manufacture liquid and lyophilized injectable forms for biotechnology-derived medicines. The facility is designed to support development studies, clinical trial batch production, and manufacturing of small commercial batches for specialized applications such as pediatric or orphan drugs.
Advanced Manufacturing Capabilities
The new pilot unit features state-of-the-art isolator technology that complies with the latest requirements of the revised Annex 1 for sterile products. The equipment enables manufacturing of a broad range of biotechnology-derived medicines, including monoclonal antibodies, mRNA in lipid nanoparticle (LNP) form, proteins, peptides, recombinant proteins, and antibody-drug conjugates (ADCs).
The isolator is designed to handle products across the full spectrum of potency classifications, from small molecules classified as Occupational Exposure Band (OEB) 1 to highly potent substances up to OEB 5, leveraging over 30 years of expertise at the Pau site.
Flexible Production and Infrastructure
The facility offers flexible batch sizes ranging from 200 to 8,000 vials, with the possibility to implement single-use systems. The unit includes an aseptic preparation area for bulk formulation, which is connected to a 2 m² lyophilizer through a unidirectional airflow aseptic filling line in full compliance with Annex 1 requirements. An autoclave is also available for products requiring terminal sterilization.
Fareva Pau features an integrated cold chain system that ensures strict temperature monitoring standards throughout every stage of the manufacturing cycle. This system maintains optimal preservation conditions for sensitive products, including storage of Drug Substances (DS), temperature maintenance of formulations before filling, and protection of Drug Products (DP) until shipment.
Comprehensive Support Services
The pilot unit benefits from full support of the existing Pau site infrastructure, including Quality Assurance, Environmental Health and Safety (EHS), Engineering, Logistics covering procurement and cold chain management, visual inspection capabilities, and packaging services. The company also provides analytical development services required for batch release, registration, validation, and stability studies.
Clinical to Commercial Pathway
The new capability supports pharmaceutical development from Phase 1 to Phase 3 studies and enables scale-up to commercialization through Fareva's industrial network of five sterile production sites. This infrastructure positions Fareva as a strategic partner for pharmaceutical and biotech companies seeking high-performance, secure solutions that align with the latest regulatory requirements.
The facility strengthens Fareva's position as a key player in sterile Fill & Finish services, offering pharmaceutical and biotech companies a comprehensive solution for bringing biotechnology-derived medicines from development through market launch.
