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Protein & Antibody Workflows — Intact Protein Characterization

질량·분리·이동 관찰을 한 결론으로 섞지 않는 evidence workspace

물질 lineage, class별 관찰, provenance, 사람의 review와 Bottom-up 인계를 분리해 기록합니다. 파일 자체를 해석하거나 단백질 identity·purity·oligomer·activity를 자동 판정하지 않습니다.

편집 가능한 시작 프로토콜

1 evidence 시작안

이 workspace는 무엇을 하나요?

Parent lot과 aliquot 상태를 먼저 고정하고, 서로 바꿀 수 없는 다섯 evidence class의 관찰·artifact·processing·review를 보존한 뒤 Bottom-up material handoff를 별도로 평가합니다.

지원하는 evidence 범위

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

적용 경계

질량·m/z·retention·migration을 서로 변환하지 않으며 identity, proteoform, purity, activity, oligomer, release 또는 분석 성공을 자동 판정하지 않습니다.

Intact Protein 작업 사본 저장소를 확인하는 중입니다.

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

공식 가이드 검토됨
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

질량·분리·이동 관찰을 한 결론으로 섞지 않는 evidence workspace

물질 lineage, class별 관찰, provenance, 사람의 review와 Bottom-up 인계를 분리해 기록합니다. 파일 자체를 해석하거나 단백질 identity·purity·oligomer·activity를 자동 판정하지 않습니다.

Research Use Only. 이 제품은 release, 임상, 규제 적합성 또는 분석 성공을 인증하지 않습니다.

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

고정된 해석 경계

  • MS neutral/assembly mass와 m/z는 서로 다른 값입니다.
  • SEC-UV retention은 분자량으로 변환하지 않습니다.
  • Native-gel migration은 exact mass 또는 stoichiometry가 아닙니다.
  • T0/T1/T2는 기록 깊이이며 sample quality가 아닙니다.

Reference mass와 observed mass의 병렬 표시는 match·identity·proteoform assignment가 아닙니다.

Comparable observation의 consistent 판정은 identity·oligomer·purity·orthogonal confirmation이 아닙니다.

고정된 해석 경계

MS neutral/assembly mass와 m/z는 서로 다른 값입니다. SEC-UV retention은 분자량으로 변환하지 않습니다. Native-gel migration은 exact mass 또는 stoichiometry가 아닙니다. T0/T1/T2는 기록 깊이이며 sample quality가 아닙니다.

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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.

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

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

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

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

조건: 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.

조건: 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.

조건: 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.

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