Peptide supply chain: difference between revisions

Diff·revision 3 → 4·05:12, 22 Oct 2024

Difference between revision 3 and revision 4 of Peptide supply chain. 12 lines changed; the page grew by 1,260 bytes.

Revision 3 — 11:53, 15 Oct 2024 Ref_Desk_Ron (talk) rm a duplicated category 1,378 bytes ±0	Revision 4 — 05:12, 22 Oct 2024 CDMO_Caradoc (talk) add the reconstitution-stability sentence with its storage condition 2,638 bytes +1,260
7	Each operation has a characteristic failure mode, and the great majority of quality observations made downstream are attributable to one of them rather than to a general property of the material or the seller.{{r\|gmp}} Knowing which stage produces which observation is what allows a purchaser to read a [[Certificate of analysis\|certificate]] as evidence about something rather than as a number.	7	Each operation has a characteristic failure mode, and the great majority of quality observations made downstream are attributable to one of them rather than to a general property of the material or the seller.{{r\|gmp}} Knowing which stage produces which observation is what allows a purchaser to read a [[Certificate of analysis\|certificate]] as evidence about something rather than as a number.
8		8
+		9	== The stages and what each can go wrong at ==
+		10	\| Stage \| What happens \| Characteristic failure mode \| Visible in \|
+		11	\|---\|---\|---\|---\|
+		12	\| Synthesis \| Residues coupled one at a time on a solid support \| Deletion sequences from incomplete coupling \| Related-substance peaks close to the main peak \|
+		13	\| Cleavage \| Peptide released from resin, side chains deprotected \| Incomplete deprotection; scavenger adducts \| Mass spectrometry; not always in ultraviolet \|
+		14	\| Purification \| Preparative reverse-phase chromatography \| Collection window too wide; co-eluting species carried through \| [[Area percent purity]] on a shallower analytical gradient \|
+		15	\| Counterion exchange \| Trifluoroacetate exchanged, or not \| Counterion left in place and unreported \| [[Peptide content]]; ion chromatography \|
+		16	\| Lyophilisation \| Frozen solution dried under vacuum \| Collapse; high residual moisture \| Cake appearance; [[Karl Fischer titration]] \|
+		17	\| Fill and finish \| Solution or powder into vials, stoppered, crimped \| Fill variation; closure integrity \| Weight check; appearance on reconstitution \|
+		18	\| Freight and storage \| Transport, customs, warehousing \| [[Temperature excursion]]; undocumented storage interval \| Nothing on the certificate \|
+		19
9	== References ==	20	== References ==
10	{{reflist}}	21	{{reflist}}
⋮		⋮
15	[[Category:Peptide synthesis]]	26	[[Category:Peptide synthesis]]
16	[[Category:Supply chain integrity]]	27	[[Category:Supply chain integrity]]
+		28	[[Category:Manufacturing and supply]]
17		29