Stand Alone Fill Finish

Utilising fully disposable systems and meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures, Cobra has the capability for sterile drug product production of DNA, mammalian and microbial protein, and API parenteral products.
With batch sizes from 1 to 100 litres, we manufacture for clinical through to commercial scale supply with products filled in single-use pre-filled syringes or injected vials. We also have the capability for freeze drying/lyophilisation of products if required.
All batch records are fully traceable under QA observation with QP review and issue of cGMP Certificate of Compliance, and regulatory documents are reviewed as required to support product release to clinic. Primary labelling of drug product vials for human clinical centres, secondary packaging and labelling of vials for dispatch to clinical centres, and tertiary and transport labelling and packaging can also be arranged according to regulatory requirements.

To request more information, please get in touch with our team.

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