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Protein & Antibody Workflows — Intact Protein Characterization

質量・分離・移動を一つの結論に混在させない evidence workspace

Material lineage、class 別 observation、provenance、人による review、Bottom-up handoff を分離して記録します。raw file の解析や identity・purity・oligomer・activity の自動判定は行いません。

編集可能な開始プロトコル

1 evidence starter

この workspace は何を行いますか？

Parent lot と aliquot state を固定し、交換不可能な5 evidence class の observation・artifact・processing・review を保存した後、Bottom-up material handoff を別に評価します。

対応 evidence 範囲

  • • A. Intact protein evidence, review & material handoff

適用範囲

mass・m/z・retention・migration を相互変換せず、identity・proteoform・purity・activity・oligomer・release・解析成功を自動判定しません。

Intact Protein の作業コピー保存領域を確認しています。

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

公式ガイド 確認済み
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

質量・分離・移動を一つの結論に混在させない evidence workspace

Material lineage、class 別 observation、provenance、人による review、Bottom-up handoff を分離して記録します。raw file の解析や identity・purity・oligomer・activity の自動判定は行いません。

Research Use Only。release、臨床・規制適合性、解析成功を保証しません。

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

固定された解釈境界

  • MS neutral/assembly mass と m/z は別の量です。
  • SEC-UV retention を molecular mass に変換しません。
  • Native-gel migration は exact mass / stoichiometry ではありません。
  • T0/T1/T2 は記録深度であり sample quality ではありません。

Reference mass と observed mass の併記は match・identity・proteoform assignment ではありません。

Comparable observation の consistency は identity・oligomer・purity・orthogonal confirmation ではありません。

固定された解釈境界

MS neutral/assembly mass と m/z は別の量です。 SEC-UV retention を molecular mass に変換しません。 Native-gel migration は exact mass / stoichiometry ではありません。 T0/T1/T2 は記録深度であり sample quality ではありません。

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.

条件: 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.

条件: 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.

条件: 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.

条件: 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.

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

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

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

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