Three biologics studies.

Research, freedom-to-operate, and formulation & CMC for monoclonal antibodies, bispecifics, antibody-drug conjugates, mRNA-LNP, AAV gene therapy, and cell therapies.

Drawing on approved biologics and biosimilars, antibody structures and sequences, the therapeutic pipeline, cell-line provenance, published lipid nanoparticle formulations and protein references. Candidates are framed in ICH Q5A to Q5E, Q6B, Q13 and Q14.

Biologics research reviewSynthesises the biologics landscape: approved products, the pipeline and the antibody references.
Biologics FTO analysisFreedom to operate for antibodies, ADCs, bispecifics, LNPs, AAV and cell therapies.
Biologics formulation and CMC studyDesigns biologic drug-product candidates for a named target.

From antibodies to cell therapies.

The three studies cover research, freedom to operate, and formulation and CMC for each of them.

Monoclonal antibodies
Bispecifics
Antibody-drug conjugates
mRNA-LNP
AAV gene therapy
Cell therapies

Each study in detail.

Each with the question it is asked, the stages it works through, and what it hands back.

01Biologics

Biologics research review

Synthesises the biologics landscape: approved products, the pipeline and the antibody references.

ICH Q5A to Q5E · Q6B · Q13Approved products · the pipeline · structures and sequences

Procedure

1Approved products
2Pipeline and competition
3Structure and sequence
4Regulatory framework
5Report

Records BLR-0001 onwards, numbered in your organisation’s own sequence.

Approved products by modality: originators, biosimilars, interchangeables, CAR-T, AAV, vaccines, advanced therapies.
The therapeutic antibody pipeline: INN, modality, stage, target, sponsor and indications.
Antibody-antigen structures, and the catalogue of therapeutic antibodies.
Cell-line provenance: CHO derivatives, HEK293 variants, hybridoma parents.

How it works

Investigates approved biologics by modality, the therapeutic antibody pipeline, antibody structures and sequences, protein references and cell-line provenance, and the regulatory framework in ICH Q5A to Q5E, Q6B and Q13. Every claim links back to the registry, patent, structure or publication behind it.

What it returns

A structured synthesis in prose: the approved-product landscape, pipeline and competitive intelligence, structural and sequence references, the regulatory framework, and open questions.

Example prompt

“What biologics are approved against TNF-α: originators, biosimilars and interchangeables?”

ReturnsBiologics synthesisapproved products · structures · pipeline

02Biologics

Biologics FTO analysis

Freedom to operate for antibodies, ADCs, bispecifics, LNPs, AAV and cell therapies.

Sequence similarity · patent landscape · approved precedentAntibody sequences from patents and literature · the patent corpus · cell-line provenance

Procedure

1Target resolution
2Patent landscape
3Approved precedents
4Blocking-claim clusters
5Report

Records BFTO-0001 onwards, numbered in your organisation’s own sequence.

Sequence-similarity FTO across paired and single-domain antibody sequences.
ADC FTO across antibody, linker, payload and conjugation chemistry.
Bispecific FTO: format (BiTE, DART, IgG-scFv, common light chain), target combination, Fc engineering.
LNP and AAV FTO: ionisable lipid combinations, capsid serotypes and engineered variants.

How it works

Maps the patent landscape by keyword and by sequence. For an antibody, submit the VH and VL sequences and it finds the closest antibody sequences disclosed in patents and literature, and the patents that claim them. It covers ADCs across all four components, bispecific formats and Fc engineering, AAV capsids and engineered variants, and LNP ionisable lipids with their helper, sterol and PEG combinations, alongside approved precedent and the clinical pipeline for the same target.

What it returns

2 to 4 design-around strategies as cards (BFTO01, BFTO02…), each with its rationale and its own risk rating of low, moderate or high.

One design-around strategy with its own risk. Illustrative example.

Example prompt

“FTO assessment for this anti-Trop2 ADC candidate: antibody VH/VL, vc-MMAE linker-payload, cysteine conjugation.”

ReturnsDesign-around strategiesBFTO01 to BFTO04 · risk per card

03Biologics

Biologics formulation and CMC study

Designs biologic drug-product candidates for a named target.

ICH Q5C · Q6B · Q2(R2) · Q14 · Q5A(R2)Approved-label precedent · excipient precedent

Procedure

1Precedent survey
2Excipient systems
3Regulatory framework
4CMC risk review
5Report

Records BCMC-0001 onwards, numbered in your organisation’s own sequence.

High-concentration mAbs: viscosity management, aggregation pathways, immunogenicity flags.
ADC drug products: linker stability, payload solubility, DAR variants.
LNP-mRNA: ionisable lipid, helper, sterol and PEG ratios from published formulations.
Stability, release specifications and CMC red flags for every candidate.

How it works

Covers high-concentration subcutaneous mAbs (viscosity, aggregation, immunogenicity, fill-finish), bispecific Fc-engineered formulations, ADC drug products (linker stability, payload solubility, DAR variants), LNP-mRNA (ionisable lipid choice, molar ratios, particle size and encapsulation targets), and CAR-T, AAV and cell-therapy cryopreservation. Excipients are checked against regulatory precedent and approved-product labels. Each rationale names the approved biologic it follows and tags every CMC red flag with its severity.

What it returns

2 to 4 design candidates (BF01, BF02…), each labelled with its modality, route and target: components, process, stability profile, release specifications to ICH Q6B, and safety notes.

A candidate labelled with its modality, route and target. Illustrative example.