Biologics suite
Research, freedom-to-operate, and formulation & CMC for monoclonal antibodies, bispecifics, antibody-drug conjugates, mRNA-LNP, AAV gene therapy, and cell therapies. Anchored to the FDA Purple Book, the EMA biosimilar and ATMP register, FDA OTAT cell- and gene-therapy products, Oxford OPIG's SAbDab / PLAbDab antibody references, Open Targets, Cellosaurus, LNP Atlas, and UniProt → PDB → AlphaFold cross-references. Reports follow ICH Q5A-E, Q6B, Q13, and Q14 verbatim.
Per agent
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ICH Q5A-E · Q6B · Q13FDA Purple Book · EMA Reg. EC 1394/2007 · FDA OTAT
Synthesizes the biologics landscape across approved-product registries, antibody references, and the pipeline.
“What biologics are approved against TNF-α: originators, biosimilars, and interchangeables?”
Example prompt
Runs broad investigations across the FDA Purple Book (351(a) originators, 351(k) biosimilars, interchangeables), EMA biosimilar and ATMP register, FDA OTAT cell- and gene-therapy products, Oxford OPIG SAbDab and Thera-SAbDab (~6,200 antibody-antigen structures), PLAbDab + PLAbDab-nano (~177,000 paired antibody sequences from patents and literature with AbLang2 embeddings), OGRDB germline references, Open Targets antibody pipeline (~980 drugs), Cellosaurus (~70,000 cell lines), and UniProt → PDB → AlphaFold protein cross-references. Returns a single coherent synthesis with a fixed H2 structure rather than a paragraph of prose with citations sprinkled in.
Returns: A structured prose synthesis covering approved-product landscape, pipeline, structural references, regulatory framework, and open questions.
Global pharma patent corpus · Approved-precedent anchoringPLAbDab + PLAbDab-nano · AbLang2 embeddings · Cellosaurus provenance
Sequence-similarity and patent-landscape FTO for antibodies, ADCs, bispecifics, mRNA-LNP, AAV, and cell therapies.
“FTO assessment for this anti-Trop2 ADC candidate: antibody VH/VL, vc-MMAE linker-payload, cysteine conjugation.”
Example prompt
Maps the IP landscape using both keyword and sequence-similarity primitives. For mAb candidates, runs vector search across ~177,000 patent- and literature-derived antibody sequences (Oxford OPIG PLAbDab + PLAbDab-nano) using AbLang2 paired embeddings to surface the closest neighbours and the patents that claim them. Covers ADC four-component FTO (antibody + linker + payload + conjugation chemistry), bispecific format and Fc-engineering claims, AAV capsid serotypes and engineered variants, and LNP ionizable-lipid + helper/sterol/PEG combinations. Cross-references the biologic product registry for approved precedent and Open Targets for clinical pipeline context.
Returns: A BFTO report with overall risk pill (low / moderate / high), closest sequence neighbours, blocking patents, and design-around paths.
ICH Q5A(R2) · Q6B · Q13 · Q14DailyMed BLA SmPC §6.1 precedent · IID + PharmaExcipients
Drug-product CMC framework memos for mAbs, bispecifics, ADCs, LNP-mRNA, AAV, and cell therapies.
“CMC memo for a 200 mg/mL anti-IL-13 IgG4 mAb for autoinjector SC delivery.”
Example prompt
Produces structured memos covering high-concentration mAb subcutaneous formulations (viscosity, aggregation, immunogenicity, fill-finish), bispecific Fc-engineered formulations, ADC drug-product formulations (linker stability, payload solubility, DAR variants), LNP-mRNA formulations (ionizable lipid grounded in LNP Atlas and LNPDB, molar-ratio rationale, particle-size and encapsulation-efficiency targets), and CAR-T / AAV / cell-therapy excipient and cryopreservation considerations. Cross-references excipients against the unified IID + PharmaExcipients surface and extracts precedent from approved-product labels via DailyMed (BLA → SETID → SmPC §6.1).
Returns: A BF CMC memo with overview, excipient rationale, regulatory framework, CMC red flags, precedent products, and recommended next steps.
Research suite
Formulation, optimization, research, FTO, patent drafting, VCM process design, and analytics.
Safety suite
ERA, extractables, leachables, nitrosamines, OEL, and PDE, anchored to ICH M7, EMA HBEL, USP <1664>, and ECETOC TR 101.
Architecture
Reality Anchor, agent routing, foundation, regulatory frameworks, and data sources: the unified platform overview.
Tell us what you are working on (molecule, indication, stage, open question).
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