{ "vercy": "1.0-draft", "publication": { "status": "research-draft", "adjudicationStatus": "unreviewed", "publishableCanonical": false, "generatedAt": "2026-09-12T11:14:57Z", "providers": [ "Codex" ], "breadth": "recalled by Codex without web access - no source was read", "missingProviders": [], "pass": 2, "cost": { "grok": { "seconds": 22.1, "error": "Reading additional input from stdin...\nOpenAI Codex v0.153.4\n--------\nworkdir: R:\\02_PROJECTS\\02_Meta_Models_Platforms\\Ver.cy\\current\\thing-registry-backlog\nmodel: gpt-6-astra\nprovider: openai\napproval: never\nsandbox: read-only\nreasoning effort: none\nreasoning summaries: none\nsession id: 01a09552-c030-7113-9e31-a175a4b7e709\n--------\nuser\nDescribe what is already known about one registered thing. Answer as JSON only, no prose around it.\n\nThing: mepolizumab\nSense to describe: (none recorded)\nDomain code: PHY.MAT\nAlso known as: (none)\n\n\nContext for this batch of 1001 things:\n# Batch 044: 1001 reg", "usd": 0.0, "recall": true }, "codex": { "seconds": 74.0, "error": "Reading additional input from stdin...\nOpenAI Codex v0.153.4\n--------\nworkdir: R:\\02_PROJECTS\\02_Meta_Models_Platforms\\Ver.cy\\current\\thing-registry-backlog\nmodel: gpt-6-astra\nprovider: openai\napproval: never\nsandbox: read-only\nreasoning effort: none\nreasoning summaries: none\nsession id: 01a09552-c027-7f80-8acc-2caaa1742a2d\n--------\nuser\nYou are drafting a Vercy meta-model for one registered thing. Answer as JSON only, no prose around it.\n\nThing: mepolizumab\nRegistry id: vr.tr.mepolizumab\nPlane / domain: PHY / PHY.MAT\nRegistry definition: (none recorded)\nNames folded into this entry: (none)\n\n\n" } }, "enrichment": { "pass": 3, "engine": "claude", "producedAt": "2026-10-06T12:00:00Z", "ingestedAt": "2026-10-06T08:56:07+00:00", "fields": [ "agent_conduct", "ethics", "failure_modes_and_hazards", "owners", "visual_identification" ] }, "gate": { "passed": true, "version": "1.0", "at": "2026-10-07T10:10:30+00:00", "evidence": [ "completeness 1.00", "sense: Wikidata description", "2 live sources", "review by codex: pass" ] } }, "metaModel": { "id": "THING-Q3306175", "registryId": "vr.tr.mepolizumab", "name": "mepolizumab", "version": "0.1.0-research.1", "entryKind": "thing", "family": "Thing Registry", "domain": [ "PHY.MAT" ], "status": "research-draft" }, "canonicalUrl": "https://ver.cy/models/thing/q3306175/", "model": { "registry_id": "vr.tr.mepolizumab", "name": "mepolizumab", "purpose": "Enable an agent to identify mepolizumab, assess the quality and usability of its material instances, and connect them to evidence-supported uses and restrictions.", "definition": "Mepolizumab is a humanized IgG1 kappa monoclonal antibody that binds interleukin-5 (IL-5), inhibiting its interaction with its receptor and reducing eosinophil survival and abundance.", "scope_statement": "This model owns mepolizumab as the biological active substance registered as vr.tr.mepolizumab in PHY / PHY.MAT, including molecular identity, functional activity, material quality, stability, and relationships to medicinal products and regulatory evidence.", "in_scope": [ "Molecular identity and reference standards for mepolizumab", "IL-5 binding and functional neutralization", "Batch composition, purity, potency, and contamination controls", "Material state and condition-dependent stability", "Links to authorized products, use restrictions, and safety evidence" ], "out_of_scope": [ "Complete Nucala product specifications, excipient formulations, packaging, and device designs", "Patient diagnosis, prescribing decisions, and individual treatment plans", "General models of eosinophils, IL-5, and eosinophilic diseases", "Manufacturing facilities and detailed production procedures", "Other therapeutic antibodies as independent substances" ], "distinguishing_features": [ "Identify the active substance as a humanized IgG1 kappa monoclonal antibody; this class identity is necessary but insufficient to establish mepolizumab identity. [FDA prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125526s007lbl.pdf)", "Verify binding to IL-5 itself and inhibition of its signaling, distinguishing ligand neutralization from direct receptor targeting. [EMA Nucala overview](https://www.ema.europa.eu/en/medicines/human/EPAR/nucala)", "Require molecular identity evidence against an authenticated mepolizumab reference; shared IL-5 binding alone does not establish that another antibody is mepolizumab.", "Distinguish the substance from Nucala, a medicinal product containing it, and distinguish active-substance mass from formulation volume. [EMA Nucala overview](https://www.ema.europa.eu/en/medicines/human/EPAR/nucala)" ], "characteristics": [ { "name": "Verified substance identity", "kind": "relation", "unit_or_values": "Authenticated sequence or structural reference and authority-qualified identifiers", "why_it_matters": "Prevents confusion with another antibody, product name, or registry synonym." }, { "name": "IL-5 binding", "kind": "measurement", "unit_or_values": "Assay-specific affinity or binding response; report units, method, and conditions", "why_it_matters": "Tests target recognition without assuming binding proves functional neutralization." }, { "name": "Functional potency", "kind": "measurement", "unit_or_values": "Relative activity against a qualified reference, with assay definition", "why_it_matters": "Separates biologically active antibody from material that merely retains measurable protein content." }, { "name": "Protein concentration", "kind": "measurement", "unit_or_values": "mg/mL with analytical method and material state", "why_it_matters": "Supports material accounting without equating concentration with potency or prescribed dose." }, { "name": "Molecular size distribution", "kind": "measurement", "unit_or_values": "Monomer, aggregate, and fragment percentages with assay basis", "why_it_matters": "Supports assessment of integrity and batch comparability." }, { "name": "Variant profile", "kind": "measurement", "unit_or_values": "Glycan, charge, and chemical-modification distributions using qualified methods", "why_it_matters": "Captures biological heterogeneity that a single formula or purity number cannot express." }, { "name": "Material context", "kind": "category", "unit_or_values": "Bulk drug substance, research preparation, or active ingredient within an identified product presentation", "why_it_matters": "Determines which quality and handling specifications apply." }, { "name": "Disposition", "kind": "state", "unit_or_values": "Pending assessment, released for specified use, quarantined, rejected, or expired", "why_it_matters": "Makes usability depend on evidence and intended use." }, { "name": "Condition history", "kind": "measurement", "unit_or_values": "Temperature in °C, elapsed time, freeze-thaw events, and documented light or agitation exposure", "why_it_matters": "Supports stability assessment against the applicable material specification." }, { "name": "Regulatory applicability", "kind": "relation", "unit_or_values": "Product, jurisdiction, indication, population, authorization status, and source date", "why_it_matters": "Prevents a product-specific authorization from becoming an unrestricted substance-level permission." } ], "affordances": [ "Match a candidate material to authenticated mepolizumab identity evidence.", "Compare batch quality and functional potency with the applicable specification.", "Flag material for quarantine when identity, integrity, or condition history is unresolved.", "Retrieve handling requirements through the exact material or product presentation.", "Trace batches into containing products and associated quality or safety reports.", "Retrieve jurisdiction-specific use restrictions for qualified clinical review." ], "agent_conduct": { "may": [ "Explain mepolizumab as an anti-IL-5 antibody used in eosinophilic conditions, citing official labelling.", "Report approved indications, injection guidance and warnings from the label." ], "must_not": [ "Recommend, dose or adjust mepolizumab for a specific person.", "Advise stopping other asthma medicines because a biologic has started.", "Present it as a rescue treatment for acute asthma attacks.", "Advise obtaining biologics from unverified sources." ], "requires_human": [ "Starting, stopping or changing biologic treatment for a patient." ] }, "ethics": { "considerations": [ "Severe asthma is life-threatening; changes to treatment need clinical oversight.", "High costs of biologics affect who can get treatment." ], "affected_parties": [ "People with severe asthma", "Prescribers and pharmacists", "Carers" ] }, "owners": { "steward": "The prescriber and the pharmacist for each patient; medicines regulators authorize products.", "master_systems": [ "National medicines registers" ] }, "visual_identification": [ "Identified by product label, active ingredient name and pack details rather than by appearance alone." ], "failure_modes_and_hazards": [ "Allergic reactions.", "Injection-site reactions.", "Loss of potency if stored incorrectly." ], "what_it_is_for": [ "Mepolizumab is encountered in specialist care for selected eosinophilic conditions, including severe eosinophilic asthma.", "Its identification supports prescription review, medicine supply and traceability, with eligibility and permitted uses determined by the applicable product authorization." ], "standards_and_regulation": [ "The Anatomical Therapeutic Chemical classification issued by the WHO Collaborating Centre for Drug Statistics Methodology assigns mepolizumab code R03DX09.", "Directive 2001/83/EC, adopted by the European Parliament and the Council of the European Union, provides a regulatory framework for human medicinal products in the European Union." ] }, "sources": [ { "id": "wikidata", "title": "Wikidata item Q3306175: mepolizumab", "url": "https://www.wikidata.org/wiki/Q3306175", "url_status": "live", "what_it_supports": "identity and sense of the item", "checked_by": "wikidata-api" }, { "id": "wikipedia-en", "title": "Wikipedia: Mepolizumab", "url": "https://en.wikipedia.org/wiki/Mepolizumab", "url_status": "live", "what_it_supports": "general description of the item", "checked_by": "wikidata-api sitelink" } ], "structure": { "bundles": [ { "id": "molecular-identity", "name": "Molecular identity", "description": "Establish what counts as mepolizumab and how that identity is demonstrated.", "rationale": "An antibody class, target, or brand name cannot uniquely identify this biological substance.", "layers": [ { "id": "reference-identity", "name": "Reference identity", "description": "Anchor the registry entry to authoritative molecular and naming records.", "findings": [ { "id": "identity-anchor", "name": "Identity anchor", "description": "Require traceable identifiers and a molecular reference before asserting material identity.", "questions": [ { "text": "Which authoritative sequence and structural records define mepolizumab?", "kind": "definition", "id": "identity-anchor-q01" }, { "text": "Which CAS, UNII, PubChem, or other identifiers resolve to this substance, and what entity does each record describe?", "kind": "provenance", "id": "identity-anchor-q02" } ] } ] }, { "id": "identity-boundaries", "name": "Identity boundaries", "description": "Separate molecular identity from related antibody classes and containing products.", "findings": [ { "id": "specificity-of-identification", "name": "Specificity of identification", "description": "Use orthogonal evidence to distinguish mepolizumab from other IL-5-pathway antibodies and from a branded formulation.", "questions": [ { "text": "Which sequence, peptide-mapping, or other identity tests distinguish mepolizumab from another IL-5-binding antibody?", "kind": "measurement", "id": "specificity-of-identification-q01" }, { "text": "Does the supplied name identify the active substance, a formulated product, or an individual container?", "kind": "boundary", "id": "specificity-of-identification-q02" } ] } ] } ] }, { "id": "il5-neutralization", "name": "IL-5 neutralization", "description": "Represent target binding, functional activity, and limits of biological inference.", "rationale": "Mepolizumab must be characterized by functional activity as well as molecular presence.", "layers": [ { "id": "target-engagement", "name": "Target engagement", "description": "Connect the antibody to its IL-5 target using assay-qualified evidence.", "findings": [ { "id": "binding-evidence", "name": "Binding evidence", "description": "Record binding measurements with target preparation, method, and experimental conditions.", "questions": [ { "text": "Which assay demonstrates mepolizumab binding to human IL-5, and what reference material was used?", "kind": "measurement", "id": "binding-evidence-q01" }, { "text": "What evidence distinguishes IL-5 binding from direct binding to the IL-5 receptor?", "kind": "boundary", "id": "binding-evidence-q02" } ] } ] }, { "id": "functional-activity", "name": "Functional activity", "description": "Assess neutralization separately from binding and clinical outcomes.", "findings": [ { "id": "potency-interpretation", "name": "Potency interpretation", "description": "Require an assay-defined neutralization result and constrain what it establishes.", "questions": [ { "text": "Which IL-5-dependent functional assay measures potency, and how is activity normalized to a reference?", "kind": "measurement", "id": "potency-interpretation-q01" }, { "text": "What additional evidence is needed before connecting an in vitro potency result to eosinophil changes or clinical benefit?", "kind": "boundary", "id": "potency-interpretation-q02" } ] } ] } ] }, { "id": "batch-quality", "name": "Batch quality", "description": "Assess the composition, integrity, and release evidence of particular mepolizumab lots.", "rationale": "A matching substance name does not establish that a biological lot has acceptable quality or intended-use suitability.", "layers": [ { "id": "protein-integrity", "name": "Protein integrity", "description": "Characterize heterogeneity and degradation against qualified acceptance criteria.", "findings": [ { "id": "variant-and-size-profile", "name": "Variant and size profile", "description": "Record molecular distributions rather than reducing the antibody to an undifferentiated purity value.", "questions": [ { "text": "What are the measured monomer, aggregate, and fragment fractions, and which methods produced them?", "kind": "measurement", "id": "variant-and-size-profile-q01" }, { "text": "Which glycan, charge, or chemical-modification differences require investigation under the applicable mepolizumab specification?", "kind": "action", "id": "variant-and-size-profile-q02" } ] } ] }, { "id": "release-and-traceability", "name": "Release and traceability", "description": "Connect contamination controls, potency results, and disposition to a specific lot.", "findings": [ { "id": "lot-suitability", "name": "Lot suitability", "description": "Require evidence appropriate to the material stage and intended use.", "questions": [ { "text": "Which producer, lot, certificate, and reference-standard records support this material's identity and release?", "kind": "provenance", "id": "lot-suitability-q01" }, { "text": "Which residual host-cell protein, residual DNA, endotoxin, and microbial controls apply at this material stage?", "kind": "measurement", "id": "lot-suitability-q02" }, { "text": "Do the documented results permit the stated use, or require quarantine or rejection?", "kind": "action", "id": "lot-suitability-q03" } ] } ] } ] }, { "id": "material-state-and-stability", "name": "Material state and stability", "description": "Interpret the physical state and exposure history of mepolizumab in a defined material context.", "rationale": "Stability and handling limits must follow the actual preparation rather than the substance name alone.", "layers": [ { "id": "preparation-context", "name": "Preparation context", "description": "Identify the matrix and presentation needed to interpret measurements.", "findings": [ { "id": "state-qualified-properties", "name": "State-qualified properties", "description": "Attach concentration, pH, and physical observations to a preparation and its conditions.", "questions": [ { "text": "Is the material bulk substance, a lyophilized preparation, a reconstituted solution, or another identified preparation?", "kind": "definition", "id": "state-qualified-properties-q01" }, { "text": "What concentration, pH, buffer context, and temperature qualify its measured properties?", "kind": "measurement", "id": "state-qualified-properties-q02" }, { "text": "Which properties belong to the containing formulation rather than to mepolizumab itself?", "kind": "boundary", "id": "state-qualified-properties-q03" } ] } ] }, { "id": "exposure-and-disposition", "name": "Exposure and disposition", "description": "Assess recorded conditions against preparation-specific stability evidence.", "findings": [ { "id": "stability-decision", "name": "Stability decision", "description": "Support use, investigation, or rejection without inventing universal storage limits.", "questions": [ { "text": "Which validated limits govern temperature, light, agitation, freezing, and time after preparation for this material?", "kind": "provenance", "id": "stability-decision-q01" }, { "text": "What exposure history and integrity results establish whether the material remains within those limits?", "kind": "measurement", "id": "stability-decision-q02" }, { "text": "What disposition is required when an excursion is documented or its duration is unknown?", "kind": "action", "id": "stability-decision-q03" } ] } ] } ] }, { "id": "authorized-use-and-safety", "name": "Authorized use and safety", "description": "Link the substance to product-specific permissions and relevant safety evidence.", "rationale": "The ability to identify active mepolizumab does not establish permission to administer a preparation.", "layers": [ { "id": "authorization-context", "name": "Authorization context", "description": "Qualify therapeutic permissions by product, population, place, and time.", "findings": [ { "id": "use-boundaries", "name": "Use boundaries", "description": "The cited US label describes maintenance uses and excludes acute bronchospasm relief; permissions must remain attached to the applicable product label. [FDA prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125526s007lbl.pdf)", "questions": [ { "text": "Which current authorization covers this product, jurisdiction, indication, age group, and administration route?", "kind": "provenance", "id": "use-boundaries-q01" }, { "text": "Does the proposed use satisfy that authorization's restrictions and disease-specific eligibility criteria?", "kind": "action", "id": "use-boundaries-q02" } ] } ] }, { "id": "safety-evidence", "name": "Safety evidence", "description": "Keep patient-facing risks, formulation effects, and occupational hazards distinct.", "findings": [ { "id": "risk-attribution", "name": "Risk attribution", "description": "The cited label addresses hypersensitivity and helminth infection precautions; record their applicability without treating them as occupational hazard classifications. [FDA prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125526s007lbl.pdf)", "questions": [ { "text": "Which safety findings concern mepolizumab, which concern excipients or administration, and which remain unattributed?", "kind": "boundary", "id": "risk-attribution-q01" }, { "text": "Which current safety document governs this preparation, including any applicable GHS classification or exposure controls?", "kind": "provenance", "id": "risk-attribution-q02" }, { "text": "Which product and lot identifiers must accompany a suspected quality defect or adverse-event report?", "kind": "action", "id": "risk-attribution-q03" } ] } ] } ] }, { "id": "evidence-and-external-alignment", "name": "Evidence and external alignment", "description": "What the world already says about this thing, gathered so the model can be checked against it.", "rationale": "A model that cannot be lined up against existing standards, identifiers and practice cannot be adopted by anyone who already uses them.", "layers": [ { "id": "reported-evidence", "name": "Reported evidence", "description": "Findings from the breadth pass, kept separate from the structural claims.", "findings": [ { "id": "evidence-confidence-notes", "name": "Check these first", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "This is recall-based information; no sources were consulted.", "Check current jurisdiction-specific prescribing information for the complete indication list, age restrictions and safety language.", "Molecular mass is approximate because antibody glycosylation is heterogeneous; elimination half-life is a pharmacokinetic estimate rather than a fixed material constant." ], "questions": [ { "id": "evidence-confidence-notes-q01", "text": "Which of these check these first hold for the sense of mepolizumab this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-identifiers", "name": "Identifiers and schemes", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ { "scheme": "International Nonproprietary Name (WHO INN)", "value_or_pattern": "mepolizumab", "note": "Names the active biological substance rather than a particular finished medicinal product." }, { "scheme": "CAS Registry Number", "value_or_pattern": "196078-29-2", "note": "Substance identifier; it does not specify formulation or manufacturing attributes." }, { "scheme": "WHO Anatomical Therapeutic Chemical classification", "value_or_pattern": "R03DX09", "note": "Therapeutic classification under other systemic drugs for obstructive airway diseases." } ], "questions": [ { "id": "evidence-identifiers-q01", "text": "Which of these identifiers and schemes hold for the sense of mepolizumab this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-standards-and-regulation", "name": "Standards and regulation", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "ICH Q6B, issued by the International Council for Harmonisation, addresses specifications and acceptance criteria for biotechnological and biological products.", "ICH Q5E, issued by the International Council for Harmonisation, addresses comparability following manufacturing changes to biological products.", "Medicinal products containing mepolizumab require authorization and approved prescribing information from regulators such as the US FDA and the European Medicines Agency." ], "questions": [ { "id": "evidence-standards-and-regulation-q01", "text": "Which of these standards and regulation hold for the sense of mepolizumab this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-real-world-use", "name": "Real-world use", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "Add-on maintenance treatment for severe eosinophilic asthma.", "Treatment of eosinophilic granulomatosis with polyangiitis.", "Treatment of selected patients with hypereosinophilic syndrome.", "Add-on treatment for chronic rhinosinusitis with nasal polyps." ], "questions": [ { "id": "evidence-real-world-use-q01", "text": "Which of these real-world use hold for the sense of mepolizumab this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-measurements", "name": "Typical measurements", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ { "quantity": "Approximate molecular mass", "typical_range": "149", "unit": "kDa" }, { "quantity": "Terminal elimination half-life following subcutaneous administration", "typical_range": "16-22", "unit": "days" } ], "questions": [ { "id": "evidence-measurements-q01", "text": "Which of these typical measurements hold for the sense of mepolizumab this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-failure-modes-and-hazards", "name": "Failure modes and hazards", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "Hypersensitivity reactions, including anaphylaxis, can occur.", "Injection-site reactions and headache are recognized adverse effects.", "It does not provide immediate relief of acute bronchospasm or status asthmaticus.", "Suppression of eosinophils raises concerns about responses to helminth infections.", "Protein aggregation or degradation caused by inappropriate storage or handling can compromise product quality." ], "questions": [ { "id": "evidence-failure-modes-and-hazards-q01", "text": "Which of these failure modes and hazards hold for the sense of mepolizumab this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-regional-variation", "name": "Regional variation", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "Authorized indications, eligible ages, presentations and prescribing conditions vary by jurisdiction and over time." ], "questions": [ { "id": "evidence-regional-variation-q01", "text": "Which of these regional variation hold for the sense of mepolizumab this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-neighbours", "name": "Neighbouring kinds and how to tell them apart", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ { "name": "Nucala", "difference": "A branded medicinal product containing mepolizumab; the product includes its formulation, presentation and regulatory authorization." }, { "name": "Reslizumab", "difference": "A different monoclonal antibody that also binds IL-5; antibody identity and clinical product characteristics distinguish it." }, { "name": "Benralizumab", "difference": "Targets IL-5 receptor alpha and promotes eosinophil depletion, whereas mepolizumab binds the IL-5 ligand." }, { "name": "Interleukin-5", "difference": "The cytokine targeted by mepolizumab, rather than the therapeutic antibody." } ], "questions": [ { "id": "evidence-neighbours-q01", "text": "Which of these neighbouring kinds and how to tell them apart hold for the sense of mepolizumab this model covers, and on what evidence?", "kind": "provenance" } ] } ] } ] } ] }, "openQuestions": [ "Which authoritative molecular reference and identifier records should anchor this registry entry, and is an existing Vercy publication already authoritative for the same substance?", "Which mepolizumab-specific specifications for potency, molecular variants, impurities, and release are publicly available, and which require controlled manufacturer documentation?", "What stability evidence exists for bulk or research preparations independently of marketed product handling instructions?", "Which current jurisdiction-specific authorizations and safety revisions supersede the cited product references?", "Which occupational classifications and physical-property records apply to mepolizumab preparations, and which requested substance constants are inapplicable or unsupported for this antibody?" ], "statistics": { "bundles": 6, "layers": 11, "findings": 18, "questions": 32 } }