FullSpectrum Characterization

FullSpectrum Characterization

Don't Leave Your Winner on the Bench

Every antibody candidate carries risk. Without early, rigorous characterization, weak leads slip through, developability issues go unnoticed, and costly surprises derail your pipeline late.

Discuss Your Characterisation Requirements

Don't Leave Your Winner on the Bench

Every antibody candidate carries risk. Without early, rigorous characterization, weak leads slip through, developability issues go unnoticed, and costly surprises derail your pipeline late.

Discuss Your Characterisation Requirements

Don't Leave Your Winner on the Bench

Every antibody candidate carries risk. Without early, rigorous characterization, weak leads slip through, developability issues go unnoticed, and costly surprises derail your pipeline late.

Discuss Your Characterisation Requirements

FullSpectrum Characterization in the FairJourney Bio Value Chain

FullSpectrum Characterization is active from Lead Selection through to Development Candidate Selection — the stage where the wrong decision costs the most. It is fully integrated with DeepDesign Engineering (feeding characterisation data back into engineering iterations) and with AtomicLevel Cryo-EM (providing structural context for characterisation findings).

Explore discovery-to-IND

Explore discovery-to-IND

The Right Depth at Every Stage

Services

FullSpectrum Characterization is not a single assay panel. It delivers the complete biophysical and biochemical picture, enabling confident candidate selection at every stage from early high-throughput screening to full CMC-readiness.

Three connected stages compose the characterisation cascade designed to generate the right data, at the right time, to drive confident decisions forward.

The Right Depth at Every Stage

Services

FullSpectrum Characterization is not a single assay panel. It delivers the complete biophysical and biochemical picture, enabling confident candidate selection at every stage from early high-throughput screening to full CMC-readiness.

Three connected stages compose the characterisation cascade designed to generate the right data, at the right time, to drive confident decisions forward.

The Right Depth at Every Stage

Services

FullSpectrum Characterization is not a single assay panel. It delivers the complete biophysical and biochemical picture, enabling confident candidate selection at every stage from early high-throughput screening to full CMC-readiness.

Three connected stages compose the characterisation cascade designed to generate the right data, at the right time, to drive confident decisions forward.

Early Screening & Lead Selection

Purpose: rank and eliminate — efficiently

SPR Kinetics Screening

Fast kinetic triage using surface plasmon resonance to assess interaction strength with the target protein. On-rate (kon), off-rate (koff), and equilibrium dissociation constant (KD) measured across large clone panels to rank-order leads for progression.

High-Throughput Binding Screen

Efficient rank-ordering of large antibody panels against the target antigen, generating binding profiles that allow rapid down-selection before deeper characterisation begins.

Early-Stage Liability Assessment

Orthogonal assays to provide meaningful insights into key properties such as thermal stability, aggregation, hydrophobicity, viscosity, solubility, propensity non-specific interactions. Signalling potential liabilities that might become red flags later in development stages.

Flow Cytometry

Cell-based binding specificity assessment against the cell surface-expressed target — confirming that binding observed in biochemical assays translates to the relevant cellular context.

Early Screening & Lead Selection

Purpose: rank and eliminate — efficiently

SPR Kinetics Screening

Fast kinetic triage using surface plasmon resonance to assess interaction strength with the target protein. On-rate (kon), off-rate (koff), and equilibrium dissociation constant (KD) measured across large clone panels to rank-order leads for progression.

High-Throughput Binding Screen

Efficient rank-ordering of large antibody panels against the target antigen, generating binding profiles that allow rapid down-selection before deeper characterisation begins.

Early-Stage Liability Assessment

Orthogonal assays to provide meaningful insights into key properties such as thermal stability, aggregation, hydrophobicity, viscosity, solubility, propensity non-specific interactions. Signalling potential liabilities that might become red flags later in development stages.

Flow Cytometry

Cell-based binding specificity assessment against the cell surface-expressed target — confirming that binding observed in biochemical assays translates to the relevant cellular context.

Early Screening & Lead Selection

Purpose: rank and eliminate — efficiently

SPR Kinetics Screening

Fast kinetic triage using surface plasmon resonance to assess interaction strength with the target protein. On-rate (kon), off-rate (koff), and equilibrium dissociation constant (KD) measured across large clone panels to rank-order leads for progression.

High-Throughput Binding Screen

Efficient rank-ordering of large antibody panels against the target antigen, generating binding profiles that allow rapid down-selection before deeper characterisation begins.

Early-Stage Liability Assessment

Orthogonal assays to provide meaningful insights into key properties such as thermal stability, aggregation, hydrophobicity, viscosity, solubility, propensity non-specific interactions. Signalling potential liabilities that might become red flags later in development stages.

Flow Cytometry

Cell-based binding specificity assessment against the cell surface-expressed target — confirming that binding observed in biochemical assays translates to the relevant cellular context.

Binding Deep Dive

Purpose: generate the data that drives lead commitment

Full SPR Kinetics

Complete kon/koff/KD determination for prioritised lead candidates. Affinity ranking and clone comparability assessment. Data generated to the standard required for lead selection documentation.

Competition and Epitope Binning

Where relevant, competition assays identify the epitope diversity across the lead panel and flag risk of redundancy or overlap. Binning data informs which leads are genuinely complementary and which represent the same binding mode.

Species Cross-Reactivity

Cross-reactivity strategy support — assessing binding to relevant species orthologues (e.g. cynomolgus monkey) to inform toxicology study design and accelerate the path to the clinic.

FcRn Binding — Half-Life Strategy

pH-dependent FcRn interaction characterised using three orthogonal approaches: affinity chromatography, interaction kinetics and affinity by SPR, and cell-based FcRn binding. Data enables informed selection of Fc variant strategy for optimised half-life.

FcγR Binding Panel — Effector Function

Binding assessment across the full FcγR panel (CD64, CD32a, CD32b, CD32c, CD16a, CD16b) with affinity and kinetics on recombinant receptor ECD by SPR — informing Fc engineering choices and effector function risk for the Target Product Profile.

Binding Deep Dive

Purpose: generate the data that drives lead commitment

Full SPR Kinetics

Complete kon/koff/KD determination for prioritised lead candidates. Affinity ranking and clone comparability assessment. Data generated to the standard required for lead selection documentation.

Competition and Epitope Binning

Where relevant, competition assays identify the epitope diversity across the lead panel and flag risk of redundancy or overlap. Binning data informs which leads are genuinely complementary and which represent the same binding mode.

Species Cross-Reactivity

Cross-reactivity strategy support — assessing binding to relevant species orthologues (e.g. cynomolgus monkey) to inform toxicology study design and accelerate the path to the clinic.

FcRn Binding — Half-Life Strategy

pH-dependent FcRn interaction characterised using three orthogonal approaches: affinity chromatography, interaction kinetics and affinity by SPR, and cell-based FcRn binding. Data enables informed selection of Fc variant strategy for optimised half-life.

FcγR Binding Panel — Effector Function

Binding assessment across the full FcγR panel (CD64, CD32a, CD32b, CD32c, CD16a, CD16b) with affinity and kinetics on recombinant receptor ECD by SPR — informing Fc engineering choices and effector function risk for the Target Product Profile.

Binding Deep Dive

Purpose: generate the data that drives lead commitment

Full SPR Kinetics

Complete kon/koff/KD determination for prioritised lead candidates. Affinity ranking and clone comparability assessment. Data generated to the standard required for lead selection documentation.

Competition and Epitope Binning

Where relevant, competition assays identify the epitope diversity across the lead panel and flag risk of redundancy or overlap. Binning data informs which leads are genuinely complementary and which represent the same binding mode.

Species Cross-Reactivity

Cross-reactivity strategy support — assessing binding to relevant species orthologues (e.g. cynomolgus monkey) to inform toxicology study design and accelerate the path to the clinic.

FcRn Binding — Half-Life Strategy

pH-dependent FcRn interaction characterised using three orthogonal approaches: affinity chromatography, interaction kinetics and affinity by SPR, and cell-based FcRn binding. Data enables informed selection of Fc variant strategy for optimised half-life.

FcγR Binding Panel — Effector Function

Binding assessment across the full FcγR panel (CD64, CD32a, CD32b, CD32c, CD16a, CD16b) with affinity and kinetics on recombinant receptor ECD by SPR — informing Fc engineering choices and effector function risk for the Target Product Profile.

CMC De-risking

Purpose: set your development candidate up for manufacturing success

Aggregation and Stability Profiling

Stress panel characterisation to assess aggregation propensity and stability under conditions relevant to manufacturing and storage. Data informs formulation strategy and identifies candidates with unacceptable CMC risk before development candidate commitment.

Forced Degradation and Robustness

Rank-order robustness assessment across conditions including heat, light, freeze-thaw, and oxidative stress — identifying which leads are most resilient to manufacturing and storage conditions.

Preformulation Scouting

Buffer and excipient compatibility screening, stability driver identification, and early formulation space definition — providing the data needed to initiate formulation development with confidence.

pCQA Identification

Probable Critical Quality Attribute (pCQA) identification and study plan design — establishing what needs to be measured, why, and when, to support the regulatory strategy.

GLP-Ready Documentation

Where required, GLP-ready documentation pathways are available to support regulatory submissions.

CMC De-risking

Purpose: set your development candidate up for manufacturing success

Aggregation and Stability Profiling

Stress panel characterisation to assess aggregation propensity and stability under conditions relevant to manufacturing and storage. Data informs formulation strategy and identifies candidates with unacceptable CMC risk before development candidate commitment.

Forced Degradation and Robustness

Rank-order robustness assessment across conditions including heat, light, freeze-thaw, and oxidative stress — identifying which leads are most resilient to manufacturing and storage conditions.

Preformulation Scouting

Buffer and excipient compatibility screening, stability driver identification, and early formulation space definition — providing the data needed to initiate formulation development with confidence.

pCQA Identification

Probable Critical Quality Attribute (pCQA) identification and study plan design — establishing what needs to be measured, why, and when, to support the regulatory strategy.

GLP-Ready Documentation

Where required, GLP-ready documentation pathways are available to support regulatory submissions.

CMC De-risking

Purpose: set your development candidate up for manufacturing success

Aggregation and Stability Profiling

Stress panel characterisation to assess aggregation propensity and stability under conditions relevant to manufacturing and storage. Data informs formulation strategy and identifies candidates with unacceptable CMC risk before development candidate commitment.

Forced Degradation and Robustness

Rank-order robustness assessment across conditions including heat, light, freeze-thaw, and oxidative stress — identifying which leads are most resilient to manufacturing and storage conditions.

Preformulation Scouting

Buffer and excipient compatibility screening, stability driver identification, and early formulation space definition — providing the data needed to initiate formulation development with confidence.

pCQA Identification

Probable Critical Quality Attribute (pCQA) identification and study plan design — establishing what needs to be measured, why, and when, to support the regulatory strategy.

GLP-Ready Documentation

Where required, GLP-ready documentation pathways are available to support regulatory submissions.

Characterisation That Moves at Your Programme's Pace

Process & Deliverables  

FullSpectrum Characterization is designed to generate decision-enabling data quickly — at microgram scale in early screening, scaling to milligram quantities as the programme progresses toward the development candidate decision. Every stage is integrated with the FairJourney Bio project lead, ensuring characterisation data feeds directly into the engineering and development strategy.

Characterisation That Moves at Your Programme's Pace

Process & Deliverables  

FullSpectrum Characterization is designed to generate decision-enabling data quickly — at microgram scale in early screening, scaling to milligram quantities as the programme progresses toward the development candidate decision. Every stage is integrated with the FairJourney Bio project lead, ensuring characterisation data feeds directly into the engineering and development strategy.

Characterisation That Moves at Your Programme's Pace

Process & Deliverables  

FullSpectrum Characterization is designed to generate decision-enabling data quickly — at microgram scale in early screening, scaling to milligram quantities as the programme progresses toward the development candidate decision. Every stage is integrated with the FairJourney Bio project lead, ensuring characterisation data feeds directly into the engineering and development strategy.

Workflow

01

Early Screening  |  µg scale

High-throughput binding screens and early developability liability assessments run across large clone panels. SPR kinetics triage identifies the lead series for progression. Early stage liability data eliminates candidates with unacceptable biophysical profiles before resource is committed.

02

Binding Deep Dive  |  µg–mg scale

Full SPR kinetics, epitope binning, cross-reactivity assessment, FcRn binding, and FcγR panel data generated for the prioritised lead series. This is the data package that supports the lead selection decision and informs the Fc engineering strategy.

03

CMC De-risking  |  mg scale

Stability, aggregation, forced degradation, and preformulation data generated for the development candidate. pCQA identification and study plan completed. GLP-ready documentation initiated where needed.

Turnaround

Individual assay turnaround times vary by assay type and panel size. For reference, in the Fc engineering case study, FcγR SPR assessment (1.2 mg), C1q SPR (100 µg), and FcRn pH-dependent characterisation (100 µg) were each completed in 1 week. Stage timelines are agreed with the partner at project initiation based on panel size and programme stage.

What You Receive

  • SPR sensorgrams and kinetics data: kon, koff, KD for all characterised candidates

  • High-throughput binding screen data: rank-ordered panels with binding profiles

  • Developability liability assessment data: AC-SINS, HIC-HPLC, Tm, non-specificity

  • FcRn binding data: affinity chromatography retention times, SPR KD values, cell-based binding

  • FcγR binding panel: full receptor coverage with affinity and kinetics

  • Epitope binning data and competition profiles where applicable

  • CMC stability and robustness data: aggregation, stress panels, forced degradation

  • Preformulation scouting results: buffer compatibility, stability drivers

  • pCQA identification and study plan

  • Intermediate reports at each stage end — raw and processed data

  • Final characterisation report: assay descriptions, data summary, lead selection rationale

Integration

  • FullSpectrum Characterization data feeds bidirectionally into the FairJourney Bio platform.

  • Characterisation findings inform further DeepDesign Engineering iterations.

  • Structural data from AtomicLevel Cryo-EM provides context for binding and specificity observations.

  • The same scientific project lead maintains continuity across characterisation, engineering, and downstream development.

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