High-throughput, high-titer CHO production of miniproteins with high yields and low endotoxin levels, surpassing traditional E. coli production methods.
Early-Stage Developability Assessments for Lead Optimization · In Silico Analysis
WuXi Biologics’ Micro Developability Platform high-throughput (HTP), low-sample-consumption assays that can evaluate biophysical properties, PK, and manufacturability.
Developability is a Key Criteria
overlooked, leading to CMC and clinical challenges. WuXi Biologics has developed the Micro Developability platform, a HTP analytical suite that in silico screening and early-stage developability testing to assess biophysical
In Silico Analysis · Immunogenicity · Aggregation
STAGE I
i
STAGE II
Poly-Specificity /PK Assessment · AC-SINS (self-interaction)
STAGE III
Manufacturability · Biophysical: DSF
· Mass spectrometry: · Peptide mapping · CIEF-MS
· · Immunogenicity · · Poor stability CMC
· Serum stability (cleavage)
Total sample required: <1 mg for most assays
Features and Applications
Key Features of the Platform: · Early stability assessments · In silico
· Mass Spec analysis
· HTP evaluation of many molecules at research stage
· ·
Figure 1
Figure 2
Evaluation of self-association tendency
· Post-translational modification · CDR hotspots · Free cysteine · Fc mutation
· Structure prediction · Hydrophobicity based · Free cysteine based
· MHC based
Evaluation of charge-
binding
Evaluation of clearance
Evaluation of half-life
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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