Contract development and manufacturing organisation (revision 3)
Old revision·00:41, 20 Nov 2024·SupplyWatchSuri
| Contract development and manufacturing organisation | |
|---|---|
| Abbreviation | CDMO |
| Function | Development and manufacture to a customer specification |
| Consequence | Brand and manufacturer are frequently different |
| Topic infobox · conventions | |
A contract development and manufacturing organisation (CDMO) develops processes and manufactures material to the specification of a customer who sells it under their own name. The arrangement is ordinary across the pharmaceutical and fine-chemical industries and is not in itself remarkable.[1]
Its consequence for anyone reading supplier documentation is that the organisation named on a catalogue is not necessarily the organisation that made the material. A brand may be a manufacturer, a distributor of its own contract-manufactured material, or a reseller of another's — and the documentation may not distinguish these.[2]
What a CDMO does
[edit]Services span process development, analytical method development, scale-up, manufacture and, in some cases, fill-finish. A customer may buy any subset: a fully developed process transferred in, or a molecule and a target specification with everything else contracted out.[1]
For peptides the capability that matters is synthesis at scale with the associated preparative chromatography, since the purification step is the one that requires the largest capital equipment. A house able to synthesise but not to purify at scale is limited to crude supply, and the distinction shows up in the specification a customer can be offered rather than in any claim about capability.[3]