In partnership with the American Peptide Association
Three programs, one standard. Each answers a different question, from a core check on every batch to the evidence needed for an American Peptide Association designation.
Core checks for safety and quality
The six checks every vial should pass. A focused answer to two questions: is it what the label says, and is it clean?
Safety 2 · Holistic peptide quality 4
Required to apply for APA designation
The full every-batch release standard
All six Essential Release tests plus 13 more across safety, peptide quality, and manufacturing control, including the vial's physical and delivery attributes.
Safety 5 · Holistic peptide quality 5 · Manufacturing discipline and control 9
Required for full APA designation
Product qualification over its labeled life
Studies that qualify the product, container, and shelf life. Performed per product, formulation, or package, then repeated periodically or after changes.
Safety 1 · Holistic peptide quality 5 · Manufacturing discipline and control 5
30 tests and studies across three pillars. Comprehensive Release includes every Essential Release test; Performance Study covers the lifecycle studies on their own.
| Test | Method | Essential Release | Comprehensive Release | Performance Study |
|---|---|---|---|---|
| Safety Control what can cause harm. | ||||
| Sterility | Membrane filtration, 14-day incubationUSP <71> | Included | Included | Not included |
| Bacterial endotoxins | Kinetic chromogenic LALUSP <85> | Included | Included | Not included |
| Visible particulates | Visual inspection against black and white backgroundsUSP <790> | Not included | Included | Not included |
| Residual solvents | Headspace GC-MSUSP <467> | Not included | Included | Not included |
| Elemental impurities and catalyst residuesRoute-level; re-verified periodically and after changes | ICP-MSUSP <232> and <233>, ICH Q3D | Not included | Included | Not included |
| Mutagenic and nitrosamine risk | Risk assessment with confirmatory LC-MS/MSICH M7, USP <1469> | Not included | Not included | Included |
| Holistic peptide quality Is it what the label says, at labeled strength? | ||||
| Identity (intact mass) | LC-HRMS | Included | Included | Not included |
| Purity and related substances | RP-UPLC, UV 214 nm, with MSICH Q3 reporting thresholds | Included | Included | Not included |
| Net peptide content | UPLC assay against reference standard | Included | Included | Not included |
| Counterion identity and content | Ion chromatography | Not included | Included | Not included |
| Structural and conformational screen | Vibrational circular dichroism (VCD) | Included | Included | Not included |
| Functional potency and biological activity | Cell-based receptor activation assay | Not included | Not included | Included |
| Binding affinitySupporting assay; optional or bridging | Surface plasmon resonance | Not included | Not included | Included |
| Peptide mapping and full sequence confirmation | LC-MS/MS | Not included | Not included | Included |
| Stereochemical integrity and epimerizationSelect peptides | Chiral amino acid analysis after hydrolysis | Not included | Not included | Included |
| Aggregation and self-association profile | SEC-UPLC and dynamic light scattering | Not included | Not included | Included |
| Manufacturing discipline and control Does the vial stay in specification? | ||||
| Cake appearance | Visual inspection | Not included | Included | Not included |
| Color | Visual comparison against color standardsUSP <631> | Not included | Included | Not included |
| Clarity and degree of opalescence | Visual comparison against reference suspensionsPh. Eur. 2.2.1 | Not included | Included | Not included |
| Reconstitution time | Timed reconstitution with the labelled diluent | Not included | Included | Not included |
| pH | PotentiometricUSP <791> | Not included | Included | Not included |
| Osmolality | Freezing point depressionUSP <785> | Not included | Included | Not included |
| Fill weight | Gravimetric | Not included | Included | Not included |
| Extractable volume | Volumetric withdrawalUSP <697> | Not included | Included | Not included |
| Water content | Karl Fischer titrationUSP <921> | Not included | Included | Not included |
| Degradation pathways and forced degradation | Stress conditions with UPLC-MSICH Q1A, Q1B | Not included | Not included | Included |
| Stability program | Timepoint testing at controlled conditionsICH Q1A | Not included | Not included | Included |
| Container closure integrity | Vacuum decayUSP <1207> | Not included | Not included | Included |
| Extractables and leachables | LC-MS, GC-MS and ICP-MS screeningUSP <1663> and <1664> | Not included | Not included | Included |
| Headspace gas and oxygen controlOxidation-sensitive or inerted products | Laser headspace analysis | Not included | Not included | Included |
| Total | 6 tests | 19 tests | 11 studies | |
Essential Release is a fixed fee per lot. Comprehensive Release is priced at laboratory cost per test plus a fixed margin. Performance Study is quoted against an agreed study plan.
