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Antibody Lead Optimization

In silico developability analysis

ProBio provides the developability anlaysis report comprises three parts: the immunogenicity analysis, post-translational modification (PTM）and antibody aggregation analysis. If high-risk issues are identified, our experts have an extensive antibody engineering capabilities to improve your antibody sequences.

Immunogenicity
prediction
PTM
analysis and
optimization
Antibody aggregation
prediction and optimization

In vitro developability assay

Some antibody drugs that have progressed into CMC or clinical stages encounter problems with non-specific binding or self-interaction. These issues often result in side effects such as immunogenicity and reduced drug efficacy, leading to substantial economic losses. In vitro developability assays should be conducted before costly in vivo animal study to reduce those developability risk.

Non-specific binding Antibody self-interaction Plasma stability
Assay type BVP ELISA DNA ELISA Affinity-capture self-interaction nanoparticle spectroscopy (AC-SINS) Plasma stability
Application mAb/bsAb/naked Ab in ADC mAb/bsAb/naked Ab in ADC mAb-Fc/bsAb/naked Ab in ADC mAb/bsAb/ADC/AOC
Timeline 1-2 weeks 1-2 weeks 1-2 weeks 2-3 weeks

Manufacturability assessment

Manufacturability assessment is one of the most important evaluation in the development of biologics, which is bridging the drug discovery and CMC. The benefits of manufacturability assessment include:

  • • Identify the development risk and reduct the costs and time
  • • Provide the good candidates, as the practice and application of QbD
  • • Provide the information for the CMC (e.g. cell culture parameters, difficulty in purification, quality attributes, etc.)

Service Package

Seivice Service content Deliverables Timeline
Basic Developability Assessment Quality attributes Test item Stressed conditions

Report:

  • Tagg
  • Conc.
  • Purity
 6-8 weeks
None 40℃ Low pH 3.5
Tagg DLS ✔ - -
Conc. UV280 ✔ ✔ ✔
Purity SEC-HPLC ✔ ✔ ✔
Purity CE-SDS-NR ✔ ✔ ✔
Premium Developability Assessment Quality attributes Test item Stressed conditions

Report:

  • Tagg
  • Tm
  • Conc.
  • Purity
  • Charge variant profiles
 6-8 weeks
None 40℃ Low pH 3.5 Freeze-thaw
Tagg DLS ✔ - - -
Tm DSC ✔ - - -
Conc. UV280 ✔ ✔ ✔ ✔
Purity SEC-HPLC ✔ ✔ ✔ ✔
Purity CE-SDS-NR ✔ ✔ ✔ ✔
Charge variants icIEF ✔ ✔ ✔ ✔
Case Study
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