Micro Developability: Early Assessment of Biologics

Micro Developability Evaluation Overview

Category

Method

Purpose / Analytical Focus

Identifies potential liabilities such as PTMs, CDR hotspots, free cysteines, Fc mutations, and amino acid usage fr equen cy Predicts immunogenic risk based on structural, hydrophobicity, and free cysteine-related factors Assesses aggregation risk b ased on sequen ce similarity, MHC binding, and humani z ation

Liability

In Silico Analysis

Immunogenicity

Aggregation

AC-SINS and HIC

Measures self-interaction tendency

BVP /DNA/Insulin ELISA Human F cRn (BLI) Serum susceptibility

Evaluates charge-b ased/non-specific binding

O ff -Target /P K-Assessment

Assesses antibody clearance

Assesses serum stability and molecules’ half-life

DSF / T agg

Detects T m , T agg

Biophysical

Solubility /Vis cosity

For high-concentration molecules

D L S

Measures particle si z e and polydispersity

Intact Mass

Analy z es clipping variants

CE-MS

Determines charge variants and heterogeneity

Mass Spec

Peptide mapping Disulfide/Gl ycan

Identifies PTMs

Characteri z es disulfide bond and glycan profiles Monitors thermal stress, low pH, free z e / thaw stability Monitors thermal stress, low pH, free z e / thaw stability Monitors thermal stress, low pH, free z e / thaw stability Monitors thermal stress, low pH, free z e / thaw stability Monitors thermal stress, low pH, free z e / thaw stability

SEC

iCIEF

Forced Degradation Studies

CE-SDS (NR/R) Peptide mapping

SPR

Antibody Developability Optimization

With multiple successful cases, our team excels in developability optimization of challenging molecules. Below are select examples showcasing how our experts resolve early developability issues to enable optimal molecular properties for CMC development.

Expression

Degradation

Non-Specific Binding Elimin a ted

Increased 7-fold

Elimin a ted

Original Optimized

300

2 00

1 00

0

0.00 1

0.0 1

0. 1 1

1 0

1 00

1 000

mAb

mAb

mAb

Original

Op timi z ed

Original

Op timi z ed

Abs (nM)

Thermal Stability

Aggregation

Pharmacokinetics

Enhanced 11 °C

Increased 160 hours

Reduced

Original

Op timi z ed

Original Purity: 53.61%

Original Optimized

Optimized Purity: 94.98%

scFv

scFv

Fusion protein

About WuXi Biologics CRO Services

WuXi Biologics is a leading global CRDMO, with the R represented by our premium-quality CRO Services. With expertise in diverse drug modalities, we deliver comprehensive research services, including antibody discovery, protein production and engineering, and in vitro/in vivo testing, to seamlessly advance our clients’ molecules from concept to CMC development.

https://www.wuxibiologics.com/cro-services/ | PS_Marketing@wuxibiologics.com Drug Development Experience Empowering Research Services for Biologics

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