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 cy Predicts immunogenic risk based on structural, hydrophobicity, and free cysteine-related factors
In Silico Analysis
Immunogenicity
Aggregation
Assesses aggregation risk b
ce similarity, MHC binding, and humani ation
AC-SINS and HIC
Measures self-interaction tendency
Evaluates charge-b
BVP
O -Target K-Assessment
Human F
Assesses antibody clearance
Serum susceptibility
Assesses serum stability and molecules’ half-life
Detects T m , T agg
DSF T agg
Biophysical
Solubility cosity
For high-concentration molecules
Measures particle si e and polydispersity
D S
Intact Mass
Analy es clipping variants
CE-MS
Determines charge variants and heterogeneity
Mass Spec
Peptide mapping
Identifies PTMs
ycan
Characteri es disulfide bond and glycan profiles Monitors thermal stress, low pH, free e thaw stability Monitors thermal stress, low pH, free e thaw stability Monitors thermal stress, low pH, free e thaw stability Monitors thermal stress, low pH, free e thaw stability Monitors thermal stress, low pH, free e thaw stability
SEC
iCIEF
Forced Degradation Studies
Peptide mapping
SPR
Antibody Developability Optimization
Expression
Degradation
Non-Specific Binding a
7-fold
a
300
00
00
0
0.00 0.0 0.
0 00 000
Op z
Op z
Abs (nM)
Thermal Stability
Aggregation
Pharmacokinetics
11 °C
160 hours
Op z
Original Purity: 53.61%
Optimized Purity: 94.98%
About WuXi Biologics CRO Services
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.
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