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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