CDMO Services
One partner, molecule to market.
Development, manufacture and distribution under a single quality system, so a programme does not change hands at every stage.
What we run
Four service lines.
Cell line and process development
Candidate to a locked, characterised process, with the analytics that prove comparability.
Clinical manufacture
GMP supply for trials, with the batch documentation regulators expect on file from day one.
Commercial supply
Validated lines that reproduce a process batch after batch, at national volume.
Distribution and cold chain
Monitored 2 to 8 degrees C distribution with per-pallet telemetry and excursion handling.
How an engagement runs
Four stages, one owner.
01
Assess
Feasibility, gap analysis and a costed plan.
02
Transfer
Process and analytics moved onto the platform.
03
Validate
Process performance qualification and release testing.
04
Supply
Commercial manufacture and lifecycle support.
What partners say
From the people who run the programmes.
The handover we were dreading never happened. The same team that developed the process ran the validation batches.
Their analytics package was the reason our dossier cleared first pass. Comparability was settled before we filed.
Capacity was reserved, not promised. That distinction is the whole relationship.
Bring us a molecule.
Send a target product profile and a market. We will come back with a costed route.