Fill
& Finish.

For the filling of its finished products, mAbxience uses Sinergium Biotech, in Argentina, and Universal Farma, in Spain, facilities.Universal Farma is one of the Insud Pharma group’s sites, which belongs to Chemo, one of the Group’s business units. As well as manufacturing the company’s own products, the plant also offers Contract Manufacturing services to third parties.

Chemo’s hallmarks include the flexibility it affords its customers and its comprehensive range of services. It boasts a team which is fully dedicated to all pre- and post-production activities, spanning from the manufacturing process transfer to the transfer of analytical methods and regulatory support.

Chemo is utterly committed to quality. All plants, including Universal Farma, comply with GMP regulations and the strictest FDA and EMA quality standards.

Chemo’sdetailed range of Contract Manufacturing services includes an area dedicated to sterile API productionand the possibility of API micronization using the Bead Milling system. Chemo also offers:

• Broad range of processes: aseptic filling, terminal sterilisation, lyophilisation and sterile API production.
• Filling formats include single dose vials, multiple dose vials and pre-filled syringes.
• Filling lines for the most advanced technology syringes and vials offering high capacity.
• Formulation under a range of conditions and batch sizes.• Product lyophilisation, as required.
• Filter sterilization and terminal sterilization.