We offer production of sterile drug products for clinical trials and commercial supply using aseptic processing.
Our comprehensive service offering includes the capability for producing sterile drug products, utilising full disposable systems and meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures.
With batch sizes from 1 to 100 litres, Cobra can manufacture for clinical trials through to commercial scale supply, with parenteral products filled in syringes or vials.
All batch records are fully traceable under QA observation with QP review and issue of GMP Certificate of Compliance, and regulatory documents are reviewed as required to support product release to clinic. Primary labelling of drug product vials / syringes for human clinical centres, secondary packaging and labelling of vials / syringes for dispatch to clinical centres, and tertiary and transport labelling and packaging can also be arranged according to regulatory requirements.