Case Study
Developability Assessment Service

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Developability Assessment Service - CD ComputaBio
Pre-development candidate de-risking

Developability Assessment Service

A promising molecule can still stall because of poor solubility, aggregation, instability, immunogenicity risk, or an impractical formulation profile. We compare the liabilities that matter for your modality so your team can choose which candidates to advance, redesign, or test next.

Physicochemical profileStabilityAggregationImmunogenicityManufacturability
Assessment criteria

Which risks matter for your molecule?

01

Physicochemical profiling

Predict solubility, pI, charge, and hydrophobicity—the properties that shape formulation and dosing.

02

Stability & aggregation

Model thermal and conformational stability plus aggregation-prone hotspots and Tagg.

03

Immunogenicity risk

Predict T-cell epitopes and deamidation or oxidation liabilities for biologics.

04

PK & ADMET screen

Flag absorption, distribution, metabolic, exposure, and toxicity liabilities for relevant modalities.

05

Manufacturability

Assess expression, viscosity, and downstream process fit; tier candidates for development.

Continue with the right specialist assessment

These four related service pages are listed in the provided website outline and can support a focused question or a broader developability program.

How teams use it

Use the assessment before the next expensive step

Candidate triage

Ranking a large lead set

You have more leads than resources to develop them. We score the full set and tier candidates so your formulation and scale-up effort lands on the most developable molecules.

  • Full-panel scoring
  • Side-by-side ranking
  • Go/no-go flags
  • Prioritized shortlist
Formulation risk

Pre-screening before formulation

Estimate stability, solubility, and aggregation risk before committing to formulation studies, and identify the measurements most likely to distinguish candidates.

  • Aggregation propensity
  • Thermal stability
  • Physicochemical profile
  • Formulation guidance
Modality-specific

Antibody, small molecule, or peptide

Each modality fails differently. We apply the panel that matches your molecule—immunogenicity and viscosity for antibodies, solubility and metabolism for small molecules.

  • Modality-matched criteria
  • Risk weighting
  • Engineering suggestions
  • Comparative report
Predict early

Why assess developability before lead selection?

A liability is more useful when the team can still change the sequence, chemistry, format, or candidate choice. We show which risks are supported by several signals and which require a targeted experiment before a decision.

ComparableCandidates scored on consistent endpoints
Modality-awareOnly relevant risks enter the panel
TraceableFlags retain evidence and assumptions
ActionableEvery major risk has a next test
Fit-to-program scope

Choose the depth that matches your decision

A single-property question, candidate triage, and engineering program need different evidence. We recommend the smallest panel that can answer the decision reliably.

1Focused liability assessment
2Comparative developability panel
3Panel, ranking, and mitigation design
Project inputs

What should you send us?

Send the data you already trust. Missing endpoints can be treated as explicit gaps rather than filled with assumptions.

  • Candidate sequences, chemical structures, or 3D models
  • Modality, format, construct boundaries, and formulation context
  • Existing solubility, stability, aggregation, expression, or ADMET data
  • Target concentration, route, storage, or manufacturing constraints
  • The candidate decision and timeline the assessment must support
Quality and limits

How do we keep the ranking realistic?

We preserve endpoint-level results, distinguish measured from predicted data, and avoid letting one composite score hide a severe liability.

  • Use modality-specific endpoints and decision thresholds
  • Check model applicability before comparing candidates
  • Report conflicting predictors and data gaps separately
  • Link uncertain risks to confirmatory laboratory assays
Important: computational developability prioritizes candidates and experiments; it does not replace formulation, biophysical, immunogenicity, pharmacokinetic, or manufacturing studies.
Decision-ready deliverables

What will your team receive?

Executive summary

Decision statement

The recommended candidate path, confidence, major evidence, and unresolved risks in plain language.

Profile report

Endpoint-level panel

Physicochemical, stability, aggregation, immunogenicity, ADMET, or manufacturability results as scoped.

Risk matrix

Liability flags

Candidate-by-endpoint comparison with severity, evidence strength, and stage-of-impact notes.

Ranking

Candidate tiering

Candidates grouped into advance, monitor, redesign, or deprioritize tiers with rationale.

Visual package

Hotspots and comparisons

Annotated structures, sequence liabilities, property charts, and candidate comparison views.

Mitigation plan

Engineering and assay guidance

Sequence, chemistry, format, formulation, and confirmatory-test options for addressable risks.

Assessment cycle

How does the assessment work?

The cycle moves from modality-specific criteria to a risk-ranked shortlist, with checkpoints that keep predictions, experimental data, and decision thresholds aligned.

Request an Assessment
  1. Define modality and criteria

    Agree the developability profile and thresholds that matter for your molecule class.

    ModalityCriteriaThresholds
  2. Gather sequences and structures

    Collect candidate sequences, structures, and any existing stability or formulation data.

    Sequence auditData inventoryGap analysis
  3. Run prediction panels

    Execute physicochemical, stability, aggregation, immunogenicity, and PK/ADMET panels.

    PhysicochemicalStabilityADMET
  4. Score and tier

    Consolidate panels into a risk matrix and rank candidates across all criteria.

    ScoringRisk matrixTiering
  5. Deliver and iterate

    Provide the report and mitigation plan, then re-assess engineered variants in the next round.

    ReportMitigationIteration
Published data

What does developability research show?

Study [1] · Antibody developability

Early developability flags predict later antibody failure

Jarasch A, Koll H, Regula JT, et al. Journal of Pharmaceutical Sciences. 2015;104(6):1885–1898.

The authors showed that a panel of early-stage developability assessments—covering aggregation, stability, and expression—can distinguish antibodies that progress from those that fail downstream, supporting developability as a selection criterion rather than an afterthought.

Service implication: our panel applies this early-screening logic across your candidate set so only developable molecules move forward.
Panel → flag → selectionOriginal schematic
Candidate setSubmit lead antibodies for screening.
Developability panelScore aggregation, stability, expression.
SelectionAdvance only developable molecules.
AggregationStabilityExpressionSelection
Study [2] · Solubility engineering

Computational solubility design de-risks aggregation

Sormanni P, Aprile FA, Vendruscolo M. Journal of Molecular Biology. 2015;427(2):478–490.

The authors demonstrated a rational, computation-guided approach to improving protein solubility and reducing aggregation propensity by identifying and mutating aggregation-prone regions, validating the value of sequence-based developability prediction.

Service implication: we use the same logic to flag aggregation hotspots and propose the mutations that would make a candidate more developable.
Sequence → hotspots → redesignOriginal schematic
Protein sequenceInput the candidate sequence.
Hotspot detectionLocate aggregation-prone regions.
Solubility redesignPropose mutations that reduce risk.
AggregationSolubilityMutationDe-risking

References

  1. Jarasch A, Koll H, Regula JT, Bader M, Papadimitriou A, Kettenberger H. Developability assessment during the selection of novel therapeutic antibodies. J Pharm Sci. 2015;104(6):1885–1898. https://doi.org/10.1002/jps.24430
  2. Sormanni P, Aprile FA, Vendruscolo M. The CamSol method of rational design of protein mutants with enhanced solubility. J Mol Biol. 2015;427(2):478–490. https://doi.org/10.1016/j.jmb.2014.09.026
Project questions

What do teams ask before starting?

The right panel depends on the modality, development stage, existing data, and decision the team needs to make.

The panel can cover solubility, charge, hydrophobicity, conformational stability, aggregation propensity, chemical liabilities, immunogenicity risk, ADMET, and manufacturability. The selected endpoints depend on the modality and project decision.

We assess antibodies and other protein therapeutics, peptides, and small molecules. Each modality uses a different set of relevant endpoints and evidence; results are not forced into one universal score.

For biologics, we identify aggregation-prone regions, surface hydrophobic or charge patches, sequence liabilities, and potential T-cell epitopes. These predictions prioritize experimental characterization and do not by themselves establish clinical immunogenicity.

ADMET focuses on absorption, distribution, metabolism, excretion, and toxicity, especially for small molecules. Developability assessment adds modality-specific properties such as solubility, stability, aggregation, viscosity, immunogenicity, and manufacturability.

Useful inputs include candidate sequences or structures, chemical structures where applicable, modality and format, formulation or route goals, known assay data, target concentration, and the decision the team needs to make.

No. Computational assessment prioritizes candidates and identifies likely liabilities, while experimental assays confirm stability, aggregation, solubility, immunogenicity, pharmacokinetics, and manufacturability under relevant conditions.

Each candidate receives an endpoint-level profile, evidence and uncertainty notes, and a risk matrix. Candidate tiers are linked to the program decision, with mitigation options for liabilities that may be addressable.

Start a project

Which candidates are ready to advance?

Share your candidate sequences or structures, modality, known assay data, and the decision your team is facing. CD ComputaBio will propose a focused panel that separates essential endpoints from optional deeper analysis.

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