Our comprehensive service offerings include the capacity for producing sterile drug products, utilising fully disposable systems and meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures.
With batch sizes from 1 to 100 litres, we manufacture for clinical through to commercial scale supply with products filled in single-use syringes
(0.5 - 10.0ml) or injected vials
(2.0 - 100.0ml), with the option of freeze drying/lyophilisation
, 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.
Speak to a member of our expert team and arrange to take a tour of our purpose built Fill finish facility
in Matfors, Sweden.