Peptide aggregation: difference between revisions
Diff·revision 19 → 20·06:36, 26 Jun 2025
Difference between revision 19 and revision 20 of Peptide aggregation. 7 lines changed; the page grew by 817 bytes.
| Revision 19 — 03:11, 7 Jun 2025 Areapercent_Ayo (talk) correct the flow rate — the source gives it in mL/min 4,377 bytes ±0 | Revision 20 — 06:36, 26 Jun 2025 PortalPolly (talk) add the system-suitability criteria the method actually specifies 5,194 bytes +817 | ||
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| 33 | Size-exclusion chromatography is the ordinary determination for aggregate content, and its result depends on the mobile phase: a dissociating buffer will report a cleaner profile than a native one on the same material. For an amylin analogue or an acylated incretin peptide, which one was used is a material question.{{r|manning2010}} | 33 | Size-exclusion chromatography is the ordinary determination for aggregate content, and its result depends on the mobile phase: a dissociating buffer will report a cleaner profile than a native one on the same material. For an amylin analogue or an acylated incretin peptide, which one was used is a material question.{{r|manning2010}} |
| 34 | 34 | ||
| + | 35 | == Practical consequences == | |
| + | 36 | Aggregation is the principal reason peptides are supplied [[Lyophilisation|lyophilised]] rather than in solution, and the principal reason a [[Beyond-use date|beyond-use date]] on a reconstituted solution is shorter than the shelf life of the powder.{{r|usp1503,ich_q1a}} | |
| + | 37 | ||
| + | 38 | Handling practices that reduce it are well established: dissolve by adding diluent down the vial wall rather than directly onto the cake, swirl rather than shake, avoid repeated freeze–thaw, and keep solutions cold. These follow from the mechanisms rather than from any particular guidance document. See [[Reconstitution of lyophilised peptides]]. | |
| + | 39 | ||
| 35 | == References == | 40 | == References == |
| 36 | {{reflist}} | 41 | {{reflist}} |
| ⋮ | ⋮ | ||
| 38 | <ref name="westermark2011">Westermark P, Andersson A, Westermark GT. "Islet amyloid polypeptide, islet amyloid, and diabetes mellitus." ''Physiological Reviews'' 91(3):795–826 (2011). PMID 21742788.</ref> | 43 | <ref name="westermark2011">Westermark P, Andersson A, Westermark GT. "Islet amyloid polypeptide, islet amyloid, and diabetes mellitus." ''Physiological Reviews'' 91(3):795–826 (2011). PMID 21742788.</ref> |
| 39 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 44 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 45 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> | |
| 40 | 46 | ||
| 41 | == See also == | 47 | == See also == |
| ⋮ | ⋮ | ||
| 45 | * [[Reconstitution of lyophilised peptides]] | 51 | * [[Reconstitution of lyophilised peptides]] |
| 46 | * [[Amylin]] | 52 | * [[Amylin]] |
| + | 53 | * [[Beyond-use date]] | |
| 47 | 54 | ||
| 48 | {{DEFAULTSORT:Peptide aggregation}} | 55 | {{DEFAULTSORT:Peptide aggregation}} |