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Protein & Antibody Workflows — Intact Protein Characterization

An evidence workspace that does not collapse mass, separation, and migration into one conclusion

Record material lineage, class-specific observations, provenance, human review, and the Bottom-up handoff separately. The product does not parse raw files or automatically claim protein identity, purity, oligomer state, or activity.

Editable starter protocols

1 evidence starter

What does this workspace do?

It locks the parent lot and aliquot states, preserves non-interchangeable observations, artifacts, processing, and reviews across five evidence classes, then evaluates a separate Bottom-up material handoff.

Supported evidence scope

  • A. Intact protein evidence, review & material handoff

Scope boundary

It never converts mass, m/z, retention, and migration into one another or automatically claims identity, proteoform, purity, activity, oligomer state, release suitability, or analytical success.

Checking the Intact Protein working-copy store.

PRT-PROTEIN-INTACT-CHAR-001A. Intact protein evidence, review & material handoff

Intact Protein Characterization Evidence and Material Handoff

Protein & Antibody Workflows > Intact Protein Characterization · PRT-INTACT-WP1-MANIFEST-20260901-A

Official guidance reviewed
EXACT_MATERIAL_LINEAGECLOSED_EVIDENCE_CLASS_UNIONSSOURCE_AND_SOFTWARE_REVISION_REQUIREDNO_CLASS_COERCIONNO_MATCH_OR_CONFIRMATION_AUTOMATIONEVIDENCE_TIER_NOT_QUALITYFAIL_CLOSED_BOTTOM_UP_HANDOFFRESEARCH_USE_ONLY

INTACT PROTEIN CHARACTERIZATION · RESEARCH USE ONLY

An evidence workspace that does not collapse mass, separation, and migration into one conclusion

Record material lineage, class-specific observations, provenance, human review, and the Bottom-up handoff separately. The product does not parse raw files or automatically claim protein identity, purity, oligomer state, or activity.

Research Use Only. This product does not certify release, clinical or regulatory suitability, or analytical success.

  1. 1. Material lineage
  2. 2. Assay class
  3. 3. Provenance
  4. 4. Observation & review
  5. 5. Material handoff

Locked interpretation boundaries

  • MS neutral/assembly mass and m/z remain different quantities.
  • SEC-UV retention is never converted to molecular mass.
  • Native-gel migration is not exact mass or stoichiometry.
  • T0/T1/T2 describes record depth, not sample quality.

Displaying declared reference mass beside observed mass is not a match, identity, or proteoform assignment.

Consistency among comparable observations is not identity, oligomer, purity, or orthogonal confirmation.

Locked interpretation boundaries

MS neutral/assembly mass and m/z remain different quantities. SEC-UV retention is never converted to molecular mass. Native-gel migration is not exact mass or stoichiometry. T0/T1/T2 describes record depth, not sample quality.

1

1. DEFINE MATERIAL LINEAGE AND INTENDED CONSUMER

Create one parent-lot identity and explicit characterized and downstream aliquot states. Record material role, research purpose, current form, current matrix, concentration provenance, remaining material, treatment history, and every unresolved unknown before interpreting evidence.

Condition: Missing parent/aliquot lineage or an undeclared consumer remains UNASSESSED and HOLD.
2

2. SELECT ONE CLOSED EVIDENCE CLASS PER ASSAY

Choose denaturing intact MS, native MS, relative SEC-UV, SEC-MALS, or relative native gel according to the actual source and observation type. Unsupported methods route to OTHER_HELD and are never coerced into the nearest registered class.

Condition: Assay-class fields are not interchangeable; absent or unsupported fields fail closed.
3

3. RECORD ACQUISITION AND TRANSFORMATION PROVENANCE

For each assay, identify specimen aliquot, pre- and post-assay state, operation class, covalent treatment, solution intent, instrument, acquisition run, software revision, source profile, artifacts, and every processing edge.

Condition: Unknown instrument/software/source revision remains explicit and prevents a complete reviewable record where required.
4

4. ENTER CLASS-SPECIFIC OBSERVATIONS WITHOUT INFERENCE

Record only the observation union supported by the selected class: neutral or assembly mass with its declared basis, source-reported m/z, SEC retention and relative signal, source-reported SEC-MALS molar mass, or relative native-gel migration.

Condition: No automatic identity, proteoform, oligomer, purity, activity, stoichiometry, or orthogonal-confirmation claim is generated.
5

5. PRESERVE EXCLUSIONS, CONFLICTS, AND UNKNOWNS

Keep excluded observations and artifacts addressable with reasons. Record incompatible or incomplete cross-assay comparisons as conflicting, insufficient, or not comparable instead of selecting, averaging, or normalizing them silently.

Condition: Unknown mass basis, SEC provenance, applicability, or lineage remains blocking or incomplete as defined by the evaluator.
6

6. REVIEW EVIDENCE TIER SEPARATELY FROM MATERIAL READINESS

Recompute T0, T1, or T2 only from the closed evidence record and explicit cross-assay review. Evidence tier is documentation depth, not sample quality, identity, release suitability, or downstream readiness.

Condition: UNASSESSED is displayed as incomplete material plus HOLD, never as an evidence-tier badge.
7

7. EVALUATE THE BOTTOM-UP MATERIAL HANDOFF

Review same-aliquot, sibling-aliquot, or collected-fraction lineage; state-changing operations; sibling applicability; fraction identity; concentration measurement; current matrix; remaining volume; and blocking unknowns before creating a typed producer receipt.

Condition: Remaining mass is not converted to volume. READY_FOR_BOTTOM_UP_REVIEW does not bypass the Bottom-up B1 review gates.
8

8. EXPORT AN EVALUATED RESEARCH RECORD

Export the parsed and evaluated typed record, source identities, evidence summary, exclusions, conflicts, unknowns, handoff status, and immutable limitations through the shared ProtocolCore DOCX/XLSX model.

Condition: Research Use Only. Corrupt, stale, oversized, or persistence-failed state locks export and remains quarantined until explicit recovery.