{ "vercy": "1.0-draft", "publication": { "status": "research-draft", "adjudicationStatus": "unreviewed", "publishableCanonical": false, "generatedAt": "2026-09-12T10:24:10Z", "providers": [ "Codex" ], "breadth": "recalled by Codex without web access - no source was read", "missingProviders": [], "pass": 2, "cost": { "grok": { "seconds": 23.2, "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: 01a09524-2050-7a53-bbc1-762c6b1b1358\n--------\nuser\nDescribe what is already known about one registered thing. Answer as JSON only, no prose around it.\n\nThing: ibalizumab\nSense to describe: (none recorded)\nDomain code: PHY.MAT\nAlso known as: (none)\n\n\nContext for this batch of 1001 things:\n# Batch 043: 1001 regi", "usd": 0.0, "recall": true }, "codex": { "seconds": 82.7, "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: 01a09524-204b-7103-8f75-8aceb9da6afe\n--------\nuser\nYou are drafting a Vercy meta-model for one registered thing. Answer as JSON only, no prose around it.\n\nThing: ibalizumab\nRegistry id: vr.tr.ibalizumab\nPlane / domain: PHY / PHY.MAT\nRegistry definition: (none recorded)\nNames folded into this entry: (none)\n\n\nCo" } }, "enrichment": { "pass": 3, "engine": "claude", "producedAt": "2026-10-06T12:00:00Z", "ingestedAt": "2026-10-06T08:48:58+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-Q3791531", "registryId": "vr.tr.ibalizumab", "name": "ibalizumab", "version": "0.1.0-research.1", "entryKind": "thing", "family": "Thing Registry", "domain": [ "PHY.MAT" ], "status": "research-draft" }, "canonicalUrl": "https://ver.cy/models/thing/q3791531/", "model": { "registry_id": "vr.tr.ibalizumab", "name": "ibalizumab", "purpose": "Enable an agent to identify ibalizumab, assess the identity and functional quality of its material, and determine which handling or use decisions require product-specific evidence.", "definition": "Ibalizumab is a humanized IgG4 monoclonal antibody that binds the CD4 receptor and inhibits HIV-1 entry after viral attachment, used with other antiretrovirals for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection.", "scope_statement": "This model owns ibalizumab as the biological active substance registered as vr.tr.ibalizumab in PHY / PHY.MAT, including molecular identity, CD4-directed activity, material quality, stability, and links to medicinal products and regulatory records.", "in_scope": [ "Antibody identity and evidence connecting substance names, sequences, and reference materials", "CD4 binding and post-attachment HIV-1 inhibition", "Lot-specific purity, structural integrity, concentration, and biological potency", "Material state, storage history, and stability evidence", "Relationships to formulations, licensed products, and jurisdiction-specific use constraints" ], "out_of_scope": [ "Trogarzo packaging, commercial presentations, and inventory management", "Patient-specific prescribing, dosing, and treatment selection", "The complete HIV-1 disease model and individual viral genomes", "Manufacturing facility operations and production process execution", "Other CD4-binding antibodies as independently identified substances" ], "distinguishing_features": [ "Its identity must match the ibalizumab reference antibody; CD4 binding alone cannot establish identity.", "It is a humanized IgG4 antibody directed at CD4 domain 2. [FDA prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761065s011lbl.pdf)", "Its antiviral classification is post-attachment HIV-1 inhibition, requiring a distinction between receptor binding and functional inhibition. [DailyMed label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c548ad82-9d1f-4d16-95b6-4e6106badf43)", "The name ibalizumab-uiyk identifies the active ingredient in the US Trogarzo label; the formulated medicinal product has additional identity and composition attributes. [DailyMed label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c548ad82-9d1f-4d16-95b6-4e6106badf43)" ], "characteristics": [ { "name": "Reference antibody identity", "kind": "relation", "unit_or_values": "Authenticated sequence, reference standard, and identifier records with versions", "why_it_matters": "Prevents another anti-CD4 antibody or an unverified research reagent from being accepted as ibalizumab." }, { "name": "Antibody class", "kind": "category", "unit_or_values": "Humanized IgG4", "why_it_matters": "Establishes the molecular class used in identity assessment. [FDA prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761065s011lbl.pdf)" }, { "name": "Protein concentration", "kind": "measurement", "unit_or_values": "mg/mL, with assay method and material state", "why_it_matters": "Supports material comparison without confusing protein amount with antiviral potency." }, { "name": "CD4 binding", "kind": "measurement", "unit_or_values": "Affinity or relative binding activity, with units, target construct, and assay conditions", "why_it_matters": "Tests target recognition while preserving differences between binding assays." }, { "name": "Antiviral potency", "kind": "measurement", "unit_or_values": "EC50 in assay-specified concentration units and maximum inhibition in %, with viral isolate and cell system", "why_it_matters": "Separates inhibition strength from the maximum inhibition achievable in a particular assay." }, { "name": "Structural purity", "kind": "measurement", "unit_or_values": "Monomer, aggregate, and fragment fractions in %, with analytical method", "why_it_matters": "Detects material changes that an identity test or concentration measurement can miss." }, { "name": "Material presentation", "kind": "category", "unit_or_values": "Bulk active substance; reference material; formulated sample; prepared administration sample", "why_it_matters": "Determines which composition and stability specifications apply." }, { "name": "Storage exposure", "kind": "state", "unit_or_values": "Temperature history in °C and duration; light, agitation, and freeze-thaw exposure; assessed or unresolved excursion", "why_it_matters": "Makes handling decisions depend on documented exposure and applicable stability evidence." }, { "name": "Quality disposition", "kind": "state", "unit_or_values": "Unassessed; quarantined; released for specified use; rejected; expired", "why_it_matters": "Distinguishes analytical identity from authorization to use a particular lot." }, { "name": "Regulatory product linkage", "kind": "relation", "unit_or_values": "Product, jurisdiction, authorization record, label version, and effective date", "why_it_matters": "Prevents one product's authorization or handling instructions from becoming universal substance properties." } ], "affordances": [ "Match a claimed ibalizumab material to authenticated identity evidence and flag unresolved discrepancies.", "Compare lot quality and antiviral potency against an applicable reference and specification.", "Assess whether a storage excursion requires quarantine or further stability review.", "Link an active-substance record to the exact formulation and current jurisdictional product documentation.", "Identify missing susceptibility evidence before interpreting an antiviral activity claim.", "Route material or use decisions to qualified review when evidence is insufficient." ], "agent_conduct": { "may": [ "Explain how ibalizumab blocks HIV entry and why it is combined with other antiretrovirals.", "Support clinicians with infusion schedules and records they have authorised." ], "must_not": [ "Recommend or alter HIV treatment for a person without their clinician.", "Disclose a person's HIV status or treatment history without consent or legal basis.", "Suggest using it alone, which invites resistance.", "Present it as a cure or as prevention for people without HIV." ], "requires_human": [ "Starting, pausing or switching a person's antiretroviral regimen.", "Sharing treatment data with insurers, employers or researchers." ] }, "ethics": { "considerations": [ "People living with HIV face stigma; privacy around their treatment is essential.", "Access to costly last-line therapies raises questions of fairness." ], "affected_parties": [ "People living with HIV", "Partners and families", "Clinicians" ] }, "owners": { "steward": "The marketing authorisation holder; the treating clinician answers for each patient's use.", "master_systems": [ "National medicines registers" ] }, "visual_identification": [ "A sterile liquid in vials for intravenous use; identity is settled by label, lot number and pharmacy records, not by appearance." ], "failure_modes_and_hazards": [ "Infusion reactions and immune reconstitution effects can occur.", "Gaps in combination therapy can let resistant virus emerge.", "Biologics degrade if cold-chain storage fails." ], "what_it_is_for": [ "This monoclonal antibody is used with other antiretroviral medicines in specialist care for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection.", "It is also encountered in pharmaceutical quality control and research where identity, purity and biological activity require separate assessment." ], "standards_and_regulation": [ "The Anatomical Therapeutic Chemical classification, maintained by the WHO Collaborating Centre for Drug Statistics Methodology, assigns ibalizumab the code J05AX23." ] }, "sources": [ { "id": "wikidata", "title": "Wikidata item Q3791531: ibalizumab", "url": "https://www.wikidata.org/wiki/Q3791531", "url_status": "live", "what_it_supports": "identity and sense of the item", "checked_by": "wikidata-api" }, { "id": "wikipedia-en", "title": "Wikipedia: Ibalizumab", "url": "https://en.wikipedia.org/wiki/Ibalizumab", "url_status": "live", "what_it_supports": "general description of the item", "checked_by": "wikidata-api sitelink" } ], "structure": { "bundles": [ { "id": "antibody-identity", "name": "Antibody identity", "description": "Establish what makes material ibalizumab and how names refer to that identity.", "rationale": "Neither an anti-CD4 label nor a trade name is sufficient to authenticate this antibody.", "layers": [ { "id": "molecular-reference", "name": "Molecular reference", "description": "Connect molecular identity tests to authenticated ibalizumab references.", "findings": [ { "id": "reference-match", "name": "Reference match", "description": "Require documented reference matching while distinguishing identity-defining features from acceptable molecular variation.", "questions": [ { "text": "Which authenticated sequence and reference standard define ibalizumab for this assessment?", "kind": "definition", "id": "reference-match-q01" }, { "text": "Which peptide-mapping, intact-mass, or other orthogonal results establish that the material matches the reference?", "kind": "measurement", "id": "reference-match-q02" } ] } ] }, { "id": "names-and-product-boundary", "name": "Names and product boundary", "description": "Resolve substance names without merging the antibody with a finished medicine.", "findings": [ { "id": "substance-name-resolution", "name": "Substance name resolution", "description": "Maintain evidence for identifiers and name mappings separately from product presentation records.", "questions": [ { "text": "Which authoritative records connect ibalizumab, ibalizumab-uiyk, and any historical development names?", "kind": "provenance", "id": "substance-name-resolution-q01" }, { "text": "Does this identifier denote the antibody substance, a research reagent, or a particular Trogarzo presentation?", "kind": "boundary", "id": "substance-name-resolution-q02" } ] } ] } ] }, { "id": "target-and-antiviral-function", "name": "Target and antiviral function", "description": "Represent target recognition and functional antiviral activity as separately evidenced properties.", "rationale": "An agent must not infer antiviral performance solely from antibody concentration or CD4 binding.", "layers": [ { "id": "cd4-recognition", "name": "CD4 recognition", "description": "Capture the target context and assay conditions behind binding results.", "findings": [ { "id": "binding-specificity", "name": "Binding specificity", "description": "Assess whether target recognition agrees with the ibalizumab reference under comparable conditions.", "questions": [ { "text": "Which CD4 construct or CD4-expressing cell system was used to characterize binding?", "kind": "measurement", "id": "binding-specificity-q01" }, { "text": "What evidence distinguishes the observed binding from nonspecific binding or recognition by another anti-CD4 antibody?", "kind": "boundary", "id": "binding-specificity-q02" } ] } ] }, { "id": "functional-susceptibility", "name": "Functional susceptibility", "description": "Keep antiviral potency tied to viral and experimental context.", "findings": [ { "id": "inhibition-profile", "name": "Inhibition profile", "description": "Record concentration-response results and investigate reduced susceptibility without assuming uniform activity across isolates.", "questions": [ { "text": "What EC50 and maximum inhibition were measured, using which viral isolate, cell system, and reference control?", "kind": "measurement", "id": "inhibition-profile-q01" }, { "text": "What paired phenotypic and viral sequence evidence supports any explanation of reduced ibalizumab susceptibility?", "kind": "provenance", "id": "inhibition-profile-q02" }, { "text": "When do incompatible assay conditions prevent comparison or require additional susceptibility testing?", "kind": "action", "id": "inhibition-profile-q03" } ] } ] } ] }, { "id": "biological-material-quality", "name": "Biological material quality", "description": "Assess whether an identified ibalizumab lot retains the quality required for its stated use.", "rationale": "A biological substance needs structural and functional quality evidence beyond small-molecule identity and purity conventions.", "layers": [ { "id": "molecular-integrity", "name": "Molecular integrity", "description": "Evaluate aggregation, fragmentation, and molecular variants against a relevant reference.", "findings": [ { "id": "variant-and-degradation-profile", "name": "Variant and degradation profile", "description": "Treat variant measurements as method-dependent evidence requiring explicit acceptance criteria.", "questions": [ { "text": "What aggregate, fragment, charge-variant, and glycan profiles were measured for this lot?", "kind": "measurement", "id": "variant-and-degradation-profile-q01" }, { "text": "Which ibalizumab specification or comparability study establishes the significance of the observed differences?", "kind": "provenance", "id": "variant-and-degradation-profile-q02" } ] } ] }, { "id": "use-specific-release", "name": "Use-specific release", "description": "Connect analytical results and contamination controls to the material's intended role.", "findings": [ { "id": "lot-qualification", "name": "Lot qualification", "description": "Distinguish qualification as an analytical reference, research reagent, bulk substance, or component of a clinical product.", "questions": [ { "text": "Which potency, residual impurity, microbial, and endotoxin requirements apply to this material stage and intended use?", "kind": "boundary", "id": "lot-qualification-q01" }, { "text": "Who authorized the lot's disposition, and which certificate and supporting results justify it?", "kind": "provenance", "id": "lot-qualification-q02" }, { "text": "Which failed or missing result requires quarantine, rejection, or further testing?", "kind": "action", "id": "lot-qualification-q03" } ] } ] } ] }, { "id": "presentation-and-stability", "name": "Presentation and stability", "description": "Determine whether the antibody remains suitable under its actual formulation and handling history.", "rationale": "Stability limits for a finished vial cannot automatically govern bulk antibody or a prepared sample.", "layers": [ { "id": "formulation-context", "name": "Formulation context", "description": "Attach physical measurements to a defined material composition and container.", "findings": [ { "id": "sample-state", "name": "Sample state", "description": "Describe the antibody's physical environment without redefining excipients as part of its molecular identity.", "questions": [ { "text": "What concentration, pH, buffer, excipients, and container describe this ibalizumab sample?", "kind": "measurement", "id": "sample-state-q01" }, { "text": "Which properties belong to the antibody, and which belong only to this formulation or prepared solution?", "kind": "boundary", "id": "sample-state-q02" } ] } ] }, { "id": "handling-history", "name": "Handling history", "description": "Compare actual exposures with evidence applicable to the material presentation.", "findings": [ { "id": "stability-disposition", "name": "Stability disposition", "description": "Use documented exposure and stability data to judge continued suitability rather than relying on appearance alone.", "questions": [ { "text": "What temperature, light, agitation, freeze-thaw, and elapsed-time exposures occurred?", "kind": "measurement", "id": "stability-disposition-q01" }, { "text": "Which study or product instruction supports the permitted limits for this exact material state?", "kind": "provenance", "id": "stability-disposition-q02" }, { "text": "Does an excursion require quarantine, additional potency testing, or disposal under the applicable procedure?", "kind": "action", "id": "stability-disposition-q03" } ] } ] } ] }, { "id": "permitted-use-and-safety-interface", "name": "Permitted use and safety interface", "description": "Link substance knowledge to current product authorization and context-specific safety evidence.", "rationale": "Material identity does not establish clinical suitability, legal availability, or the safety of a particular exposure.", "layers": [ { "id": "authorization-context", "name": "Authorization context", "description": "Keep therapeutic claims attached to a jurisdiction, product, population, and document version.", "findings": [ { "id": "clinical-use-boundary", "name": "Clinical use boundary", "description": "The US label describes combination treatment for heavily treatment-experienced adults with multidrug-resistant HIV-1 whose current regimen is failing. [DailyMed label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c548ad82-9d1f-4d16-95b6-4e6106badf43)", "questions": [ { "text": "Which current authorization and label govern the linked product in the intended jurisdiction?", "kind": "provenance", "id": "clinical-use-boundary-q01" }, { "text": "Which population and combination-treatment restrictions must be passed to the prescribing model?", "kind": "boundary", "id": "clinical-use-boundary-q02" } ] } ] }, { "id": "exposure-specific-safety", "name": "Exposure-specific safety", "description": "Separate therapeutic safety evidence from laboratory handling and environmental hazard assessment.", "findings": [ { "id": "safety-evidence-routing", "name": "Safety evidence routing", "description": "The product label includes hypersensitivity and in-utero exposure warnings; these require contextual review. [DailyMed label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c548ad82-9d1f-4d16-95b6-4e6106badf43)", "questions": [ { "text": "Which safety claims concern the antibody, formulation components, administration procedure, or combination regimen?", "kind": "boundary", "id": "safety-evidence-routing-q01" }, { "text": "Which current safety data sheet and exposure evidence govern laboratory handling, spills, and waste for this material?", "kind": "provenance", "id": "safety-evidence-routing-q02" }, { "text": "Which unresolved exposure or safety issue requires specialist review before the proposed use proceeds?", "kind": "action", "id": "safety-evidence-routing-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 a recall-based description; no sources were consulted.", "Current jurisdiction-specific authorization, availability, administration instructions and safety labeling require verification.", "Exact chemical database identifiers, molecular mass and product-specific quality specifications require verification; small-molecule melting and boiling points are not useful routine descriptors for this antibody." ], "questions": [ { "id": "evidence-confidence-notes-q01", "text": "Which of these check these first hold for the sense of ibalizumab 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": "ibalizumab", "note": "Names the antibody substance rather than a finished medicinal product." }, { "scheme": "FDA nonproprietary biological product name", "value_or_pattern": "ibalizumab-uiyk", "note": "United States proper name for the active biological ingredient in Trogarzo." }, { "scheme": "Proprietary medicinal product name", "value_or_pattern": "Trogarzo", "note": "Brand name for a medicinal product containing ibalizumab." } ], "questions": [ { "id": "evidence-identifiers-q01", "text": "Which of these identifiers and schemes hold for the sense of ibalizumab 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": [ "United States FDA biologics licensure and prescribing information govern the approved Trogarzo product.", "ICH Q6B addresses specifications, test procedures and acceptance criteria for biotechnological and biological products." ], "questions": [ { "id": "evidence-standards-and-regulation-q01", "text": "Which of these standards and regulation hold for the sense of ibalizumab 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": [ "Used with other antiretrovirals in heavily treatment-experienced adults with multidrug-resistant HIV-1 whose current regimen is failing.", "Provides an HIV entry-inhibition mechanism distinct from reverse-transcriptase, protease and integrase inhibition." ], "questions": [ { "id": "evidence-real-world-use-q01", "text": "Which of these real-world use hold for the sense of ibalizumab 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": "Approximately 150", "unit": "kDa" }, { "quantity": "Antiviral treatment response", "typical_range": "Measured as change in plasma HIV-1 RNA; no single response range applies", "unit": "copies/mL" } ], "questions": [ { "id": "evidence-measurements-q01", "text": "Which of these typical measurements hold for the sense of ibalizumab 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": [ "HIV-1 can develop reduced susceptibility, including through changes in envelope glycoprotein glycosylation.", "Hypersensitivity reactions can occur.", "Immune reconstitution inflammatory syndrome can occur during effective combination antiretroviral treatment.", "Reported adverse reactions include diarrhea, dizziness, nausea and rash.", "As a protein biologic, degradation or aggregation can compromise product quality if storage and handling requirements are not met." ], "questions": [ { "id": "evidence-failure-modes-and-hazards-q01", "text": "Which of these failure modes and hazards hold for the sense of ibalizumab 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": "Trogarzo", "difference": "Trogarzo is a formulated medicinal product; ibalizumab is its active antibody substance." }, { "name": "Fostemsavir", "difference": "Its active metabolite binds viral gp120 and inhibits attachment; ibalizumab binds host CD4 and inhibits entry after attachment." }, { "name": "Maraviroc", "difference": "Maraviroc antagonizes the host CCR5 coreceptor; ibalizumab targets CD4." }, { "name": "Enfuvirtide", "difference": "Enfuvirtide is a peptide targeting viral gp41-mediated fusion; ibalizumab is an antibody targeting host CD4." } ], "questions": [ { "id": "evidence-neighbours-q01", "text": "Which of these neighbouring kinds and how to tell them apart hold for the sense of ibalizumab this model covers, and on what evidence?", "kind": "provenance" } ] } ] } ] } ] }, "openQuestions": [ "Which authoritative sequence, substance identifiers, historical names, and reference standards can be reconciled into one verified ibalizumab identity record?", "Which lot-release limits and comparability criteria for potency, aggregates, glycoforms, and process impurities are publicly available or require manufacturer documentation?", "Which viral determinants and assay methods support reproducible interpretation of reduced ibalizumab susceptibility, and are validated clinical thresholds available?", "What stability evidence exists for bulk substance, research preparations, and handling excursions beyond the licensed product's documented conditions?", "Which jurisdiction-specific authorizations and material-specific hazard records apply, and which conventional chemical fields such as boiling point or exposure limits should be marked inapplicable rather than missing?" ], "statistics": { "bundles": 6, "layers": 11, "findings": 17, "questions": 31 } }