Contract development and manufacturing organisation: difference between revisions
Diff·revision 1 → 2·22:25, 11 Nov 2024
Difference between revision 1 and revision 2 of Contract development and manufacturing organisation. 6 lines changed; the page grew by 925 bytes.
| Revision 1 — 09:00, 8 Nov 2024 MoveRequestMio (talk) new article: supply and handling, expansion welcome 1,327 bytes +1,327 | Revision 2 — 22:25, 11 Nov 2024 SPPS_Sorrel (talk) rm the shipping recommendation — that is advice, not description 2,252 bytes +925 | ||
|---|---|---|---|
| 10 | 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.{{r|iso9001}} | 10 | 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.{{r|iso9001}} |
| 11 | 11 | ||
| + | 12 | == What a CDMO does == | |
| + | 13 | 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.{{r|ich_q7}} | |
| + | 14 | ||
| + | 15 | For peptides the capability that matters is [[Solid-phase peptide synthesis|synthesis]] at scale with the associated [[Preparative HPLC purification|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.{{r|usp1503}} | |
| + | 16 | ||
| 12 | == References == | 17 | == References == |
| 13 | {{reflist}} | 18 | {{reflist}} |
| 14 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 19 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| 15 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | 20 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> |
| + | 21 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 16 | 22 | ||
| 17 | {{DEFAULTSORT:Contract development and manufacturing organisation}} | 23 | {{DEFAULTSORT:Contract development and manufacturing organisation}} |