Search from website

Early Antibody Developability Assessment

Our early antibody developability assessment bridges cost-efficient in silico prediction with targeted experimental validation.

De-risk your antibody candidates early with comprehensive biochemical, biophysical, and functional characterization.
Icosagen provides integrated early developability screening to help identify the most promising antibody candidates and discard unsuitable candidates before entering expensive development stages.

Our early antibody developability assessment bridges cost-efficient in silico prediction with targeted experimental validation.

De-risk your antibody candidates early with comprehensive biochemical, biophysical, and functional characterization.
Icosagen provides integrated early developability screening to help identify the most promising antibody candidates and discard unsuitable candidates before entering expensive development stages.

Our early antibody developability assessment bridges cost-efficient in silico prediction with targeted experimental validation.
Our early antibody developability assessment bridges cost-efficient in silico prediction with targeted experimental validation.

Trusted CRDMO Partner for Pharma & Biotech

Read the testimonials ↙

INTEGRATED CRDMO APPROACH

INTEGRATED CRDMO APPROACH

We Combine CRO and CDMO Expertise Under One Roof

We Combine CRO and CDMO Expertise Under One Roof

Early integration of developability assays into discovery workflows enables rapid, data-driven assessment of key quality attributes before major development investment. This supports earlier risk identification, improved candidate selection, and faster progression of robust therapeutics.

 

Early integration of developability assays into discovery workflows enables rapid, data-driven assessment of key quality attributes before major development investment. This supports earlier risk identification, improved candidate selection, and faster progression of robust therapeutics.

 

Discover What Early Antibody Developability Package Provides

In vitro Developability Profiling

Streamline your antibody development with early insights into expression, stability, functionality, and manufacturability.

Our in vitro developability assessments help you identify the most promising candidates, reduce downstream risks, and accelerate progression to successful therapeutics, all while making informed, data-driven decisions.
An overview of Icosagen's in vitro developability assay.

Overview of In Vitro Developability Profiling Capabilities

Explore the capabilities below ↓

Therapeutic antibodies must combine high potency with good developability, including stability, manufacturability, and suitable pharmacokinetics. However, many candidates fail late due to issues such as aggregation, instability, or low expression, leading to costly delays. Our early developability assessment using in vitro biochemical, biophysical, and functional assays helps identify these risks and prioritize lead candidates. 

Identify key molecular characteristics upfront – expression, functionality, purity, and stability so you can make informed decisions earlier, reduce downstream risks, and accelerate your path to a successful therapeutic.

Antibody Titer Measurement via Protein A Binding

  • Assess expression and productivity early in development.
  • Confirm Fc integrity and binding functionality, critical for purification and therapeutic activity.
This HPLC-based technique isolates functional antibodies from complex samples (e.g., cell lysates) by binding the antibody Fc domain to protein A. After unbound material is removed, the captured antibodies are released using a low pH elution buffer. The amount of functional antibody (titre) is then quantified using a species- and isotype-matched calibration curve.
Antibody titer measurement via Protein A binding.

Intact MS (reduced/non-reduced)

  • Critical early insight: Shows if the molecule is intact or signal peptide is misprocessed.​
  • Drives proactive redesign: Enables sequence or signal peptide changes before costly failures.​
Intact MS graph of an antibody.
Intact MS graphs of antibody light and heavy chains.

Post-affinity aSEC

  • Evaluation of antibody purifiability and monodispersity.
  • First estimate of molecular weight.
aSEC on calibrated HPLC columns quantifies monomer peaks and detects multimers and aggregates, providing a fast and precise  product quality profile immediately after affinity purification.



Post-affinity aSEC chromatogram. Detect monomer peaks, multimers and aggregates. Evaluation of antibody purifiability and monodispersity. First estimate of molecular weight.
Identify antibodies with polyreactivity, (low) stability, self-association, and proteolysis risks upfront, helping you eliminate candidates likely to have poor pharmacokinetics, reduced efficacy, or formulation challenges.

Off-target Binding. Polyreactivity ELISA

  • Polyreactive antibodies often show poor PK, off-target binding, and higher clearance.
  • Scoring function and pass/fail classification.
Assessing non-specific antibody binding to multiple unrelated biomolecules in an ELISA format. Non-specific binding can lead to poor pharmacokinetics and reduced efficacy. Our panel covers several major nonspecific binders:
  • Nucleic acids
  • Protein antigens
  • Lipid antigens
  • VLPs – enveloped virus-like particles
  •  
Assessing non-specific antibody binding to multiple unrelated biomolecules Polyreactive antibodies often show poor PK, off-target binding, and higher clearance. Scoring function and pass/fail classification.

Off-target Binding. Western-blot Detection of Linear Epitopes

  • Linear epitopes are less likely to be unique.
  • Linear epitope binding is associated with a higher cross-reactivity risk.
Antibody binding on a Western therefore indicates recognition of linear (continuous) epitope. Western blotting requires SDS-PAGE, which: Denatures proteins, Disrupts secondary and tertiary structure, Leaves proteins largely as linear polypeptide chains.



Antibody binding on a Western therefore indicates recognition of linear (continuous) epitope.

Stability – Nano-differential Scanning Fluorimetry (nanoDSF)

  • Low Tm provides early warning signal for potentially problematic downstream behaviour.
  • Allows to eliminate less stable, “fragile” candidates.
nanoDSF provides fast and label-free measurement of antibody unfolding as temperature increases by tracking changes in intrinsic fluorescence from aromatic residues.This causes a shift in fluorescence intensity or wavelength. The unfolding transition is summarized as a melting temperature (Tm), which is a general indicator for antibody stability.



NanoDSF to determine antibody thermal stability.

Aggregation Propensity – Static Light Scattering (SLS)

  •  A low Tagg provides an early warning sign for increased risk of self-association and aggregation, which is correlated with a PK risk.
  •  Low-Tagg candidates can be further scrutinized using complementary techniques (aHIC and AC-SINS).
Aggregation temperature (Tagg) is determined by Static Light Scattering (SLS) to assess antibody aggregation propensity under thermal stress. Aggregation is measured as an increase in scattered light intensity.



Aggregation Propensity – Analytical Hydrophobic Interaction Chromatography (aHIC)

  • aHIC separates antibodies based on their hydrophobicity, with stronger binding observed as later retention times.
  • Strong aHIC retention correlates with aggregation, self-association, lower solubility, and higher viscosity.
Analytical hydrophobic interaction chromatography (aHIC) is an HPLC-based technique that separates antibodies based on their hydrophobicity, with stronger binding observed as later retention times.
Aggregation propensity – Analytical hydrophobic interaction chromatography (aHIC).

Aggregation Propensity – Affinity-capture Self-interaction Nanoparticle Spectroscopy (AC-SINS)

  •  Provides a measure for antibody-antibody interactions that drive aggregation.
  •  High AC-SINS correlate with increased non-specific binding and reduced serum half-life.
AC-SINS (Affinity-Capture Self-Interaction Nanoparticle Spectroscopy) is a solution-based assay that measures antibody self-association by capturing antibodies onto gold nanoparticles and detecting plasmon wavelength shifts.
Aggregation propensity – Affinity-capture Self-interaction nanoparticle spectroscopy (AC-SINS)

Antibody Half-life Prediction via FcRn Chromatographty

  • FcRn binding dictates the pharmacokinetic fate of therapeutic antibodies
  • Strong binding in acidic endosomes prevents lysosomal degradation 
  • Rapid release in blood in blood extends serum persistence 

 

Early release (< pH 7.0) 
Risk of degradation in the lysosome

Optimal release (pH 7.0-7.5)
Warrants strong binding in endosome and complete release in blood stream

Late release (> pH 7.5)
Risk of antibody staying bound to the receptor on the cell surface

FcRn affi nity chromatography. The neonatal Fc receptor (FcRn) dictates the pharmacokinetic fate of therapeutic antibodies. Strong binding in acidic endosomes prevents lysosomal degradation. Rapid release in blood stream extends serum persistence.
Early binding characterization enables rapid ranking of antibody candidates by functional performance and biological relevance, supporting informed down-selection and reducing risk before advancing into resource-intensive development stages.

ELISA EC₅₀ for Soluble and Membrane Proteins

  • Supports rapid ranking and potential assay interference.​
  • Guides down-selection of antibody leads,flagging candidates with too weak binding,atypical dose–responses​
ELISA EC50. Guides down-selection of antibody leads, fl agging candidates with too weak binding, atypical doseresponses.

Flow Cytometry–Based EC₅₀ Determination

  • Provides biologically direct measurements that preserve native cellular context and provide higher sensitivity than ELISA-based assays.​
  • De-risking and rating antibodies at the cell level.​
Flow cytometry measures antibody potency on living cells by tracking dose-dependent binding via fluorescently labeled antibodies and calculating EC₅₀ from the resulting dose–response curve.



Flow Cytometry–Based EC₅₀ Determination.

Membrane Protein Binding Kinetics by Biolayer Interferometry (BLI)

Kinetic binding analysis quantifies how fast two molecules bind and separate over time. This allows to record the 3 core parameters of an antibody-antigen interaction:​
k - association rate constant, ​
how quickly the antibody binds its target
kd - dissociation rate constant, 
how quickly the antibody unbinds
KD - equilibrium dissociation constant, ​
the overall binning affinity
Membrane Protein Binding Kinetics by Biolayer Interferometry – BLI. Binding affi nity alone (KD) does not accurately predict in vivo behaviour. The binding rates are crucial. Kinetic analysis therefore facilitates translational PK modelling.

High-throughput Protein Binding Kinetics by Surface Plasmon Resonance (SPR)

  • Binding kinetics – not just affinity are key to predicting in vivo behavior and guiding PK modeling.​
  • Kinetic analysis informs mechanism of action and guides rational antibody optimization.
  • Competition screening identifies identical or overlapping antibody epitopes.
High-throughput Protein binding kinetics by Surface Plasmon Resonance (SPR).

In silico Screening of Developability Liabilities

Structure-based computational screening flags antibodies with potential stability, aggregation, or chemical liabilities before experimental testing.

By linking in silico predictions to clinical-stage data, we help you prioritize high-potential candidates, save time and resources, and reduce the risk of late-stage failures.

An overview of Icosagen's in silico developability assay.

Overview of In Silico Developability Profiling Capabilities

Explore the capabilities below ↓

Structure-based Prediction with Molecular Dynamics (MD) Ensembles for More Reliable Risk Prediction

Prediction of parameters with adverse effects on manufacturability and pharmacokinetic risk projection:

Chemical liabilities: 

  • Asn-deamidation
  • Met/Trp-Oxidation
  • N-glycosylation
  • Asp-isomerization
  • Free Cys

Biophysical liabilities:

  • Hydrophobicity Patches
  • Electrostatic imbalance
  • Aggregation-prone regions
  • Poor VH/VL packing
  • Ensemble energetics
Prediction of parameters with adverse effects on manufacturability and Pharmacokinetic risk projection.

Chemical liabilities: 

  • Asn-deamidation
  • Met/Trp-Oxidation
  • N-glycosylation
  • Asp-isomerization
  • Free Cys

Biophysical liabilities:

  • Hydrophobicity Patches
  • Electrostatic imbalance
  • Aggregation-prone regions
  • Poor VH/VL packing
  • Ensemble energetics
Prediction of parameters with adverse effects on manufacturability and Pharmacokinetic risk projection.

Computational predictions of biophysical risks correlate reasonably well with experimental data from clinical stage therapeutic antibodies. 

  • Flag risky molecules before expression, purification, or scale-up.
  • Quantitative link between fast in silico developability predictions and gold-standard experimental data.
Computational predictions of biophysical risks correlate reasonably well with experimental data from clinical stage therapeutic antibodies.
This is a photo of Sebastian Zoll.

Meet our experts

The Experts Behind Our Early Antibody Developability Package
Dr. Sebastian Zoll is a structural biologist and protein biochemist with extensive expertise in structural biology, protein engineering, and antibody developability. As Head of Protein Analytics at Icosagen, he leads advanced cryo-EM–based analytics to support early-stage antibody assessment and optimization.
He earned his PhD in structural biology from the University of Tübingen, studying cell wall cleavage in multi-resistant Staphylococcus strains. After research stays at IOCB Prague and the University of Oxford, where he worked on intramembrane proteases and parasite surface proteins, he developed a strong interest in host–parasite interactions, particularly the sleeping sickness parasite. In 2019, he established his own laboratory at IOCB Prague, focusing on structural studies of interactions between human innate immune factors and parasite surface antigens using cryo-EM.

At Icosagen, Dr. Zoll drives the development of structural insights that help de-risk antibody candidates and accelerate biologics development.

FAIL LATE = FAIL EXPENSIVE

FAIL LATE = FAIL EXPENSIVE

How We Minimize Your Risks With Early Developability Assessment?

How We Minimize Your Risks With Early Developability Assessment?

Even highly potent antibodies can fail during development due to poor stability, aggregation, manufacturing challenges, or unfavorable pharmacokinetic properties. Early developability assessment identifies these liabilities before expensive downstream development begins.
Even highly potent antibodies can fail during development due to poor stability, aggregation, manufacturing challenges, or unfavorable pharmacokinetic properties. Early developability assessment identifies these liabilities before expensive downstream development begins.

Frequently Asked Questions

Didn’t find the answer? Ask us a question!

Antibody developability refers to the assessment of whether an antibody candidate has the properties required for successful manufacturing, stability, and clinical development.
Early screening identifies liabilities such as aggregation, instability, or unfavorable modifications before costly development stages.

Key properties include:

  • Structural and thermal stability
  • Aggregation propensity
  • Solubility and viscosity
  • Expression yield and scalability
  • Sequence liabilities and immunogenicity risks
     
Developability assessment identifies candidates with favorable expression, stability, and scalability profiles. This reduces challenges during process development and ensures smoother transition to GMP manufacturing.
Yes. A comprehensive developability assessment typically combines computational (in silico) analysis with experimental validation, providing a complete understanding of antibody behavior.
It is common to assess multiple lead candidates in parallel. This enables data-driven ranking and selection of the most promising antibody for further development.
Yes. Developability assessment is often integrated with antibody discovery, engineering (e.g., affinity maturation, humanization), and protein production to support seamless progression of antibody programs.

Integrated CRO and CDMO services