Peptide synthesis: difference between revisions
Diff·revision 26 → 27·14:41, 2 Sep 2025
Difference between revision 26 and revision 27 of Peptide synthesis. 3 lines changed; the page grew by 682 bytes.
| Revision 26 — 12:18, 12 Aug 2025 AnalyticalAnnie (talk) add the crimp-seal step to the fill-and-finish description 4,967 bytes ±0 | Revision 27 — 14:41, 2 Sep 2025 FlowTrialFraser (talk) add the note that lyophilised material tolerates excursions better than solution 5,649 bytes +682 | ||
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| 35 | The resulting crude is precipitated, then purified by [[Preparative HPLC purification|preparative chromatography]] and isolated by [[Lyophilisation|lyophilisation]]. Because the mobile phase is acidified with trifluoroacetic acid, the isolated solid is a [[Trifluoroacetate counterion|trifluoroacetate salt]] unless exchanged.{{r|usp1503}} | 35 | The resulting crude is precipitated, then purified by [[Preparative HPLC purification|preparative chromatography]] and isolated by [[Lyophilisation|lyophilisation]]. Because the mobile phase is acidified with trifluoroacetic acid, the isolated solid is a [[Trifluoroacetate counterion|trifluoroacetate salt]] unless exchanged.{{r|usp1503}} |
| 36 | 36 | ||
| + | 37 | Every stage leaves a signature that analysis can find: deletion sequences from coupling, oxidised and alkylated residues from cleavage, residual solvent from purification, counterion from the mobile phase. This is why a peptide impurity profile is informative about how a material was made, and why an itemised related-substances table is worth more than an aggregate figure.{{r|usp1503}} In regulated manufacture the same reasoning appears as the requirement to control process-related impurities at their source.{{r|ich_q7}} | |
| + | 38 | ||
| 37 | == References == | 39 | == References == |
| 38 | {{reflist}} | 40 | {{reflist}} |
| ⋮ | ⋮ | ||
| 40 | <ref name="behrendt2016">Behrendt R, White P, Offer J. "Advances in Fmoc solid-phase peptide synthesis." ''Journal of Peptide Science'' 22(1):4–27 (2016). DOI:10.1002/psc.2836. PMID 26785684.</ref> | 42 | <ref name="behrendt2016">Behrendt R, White P, Offer J. "Advances in Fmoc solid-phase peptide synthesis." ''Journal of Peptide Science'' 22(1):4–27 (2016). DOI:10.1002/psc.2836. PMID 26785684.</ref> |
| 41 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 43 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 44 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | |
| 42 | 45 | ||
| 43 | == See also == | 46 | == See also == |