Sterile Fill Finish

Our facility was purpose-built to meet increasing market demand for small-scale, shorter sterile drug product development timelines, while consistently maintaining regulatory compliance.

Today, we reliably support our customers with the aseptic filling and lyophilization of conventional, biologic and cytotoxic drugs into vials. Helping clients across the globe meet their project milestones, we provide rapid access to manufacturing slots and quick release of drug product to ensure tight timelines are successfully met.

Aseptic filling of sterile drugs, also known as sterile filling/finish, remains one of the most critical processes in biopharmaceutical manufacturing. This is due to it’s highly technique driven processes and the potential safety impact to the end user, usually an already compromised patient. There are only indirect safeguards for the sterility of the filled drug after it is stoppered and capped in the cleanroom.

Our sterile fill finish capabilities include:
Filling into 2ml-100ml glass vialsBulk volume of up to 70 litresBulk lyophilisation in Lyoguard traysBatch sizes range from 100-3000 vialsControlled-temperature fillingIn-house vial washing and GMP manufacture of small moleculesGMP manufacture of biologics such as antibodies, proteins, peptides, DNA, ADCsGMP manufacture of Cytotoxics/Cytostatics/High Potent APIs in dedicated cleanroom facilityDrug product manufactured under GMP to meet regulations for clinical trials in US and Europe depyrogenation