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Our Top 12 Methods to Characterize ADCs and Bispecific/Multispecific Therapeutics


Characterization and Quantification of Structural Attributes of Your ADC and Bispecific/Multispecific Products

Our team of PhD-level experts has extensive experience working with complex conjugated platforms such as ADCs and multispecific therapeutics throughout all stages of development.

Through strategic application of advanced LC-MS and biophysical-based analytics and data analysis, BioAnalytix develops and applies analytic methods to accurately quantify and characterize critical ADC and bispecific/multispecific conjugation structures, stoichiometries, and binding site ratios.

Our top 12 analytic programs include:

Antibody Drug Conjugate:

  1. Drug and Drug-Linker Conjugation Site and Occupancy Mapping
  2. Drug Antibody Ratio (DAR) Analysis
  3. DAR Distribution via HIC and Native-MS
  4. Residual Quenched Drug Linker (QDL) in DS
  5. In Vivo CQA Mapping of Conjugated Profiles (Along with Quantitative PK Evaluation)
  6. Complete MS Characterization Including Sequence Variant Analysis of the Parental Antibody

Bispecific/Multispecific Antibodies:

  1. Heavy/Light Chain Structural Confirmations and Mispairing Analysis
  2. Binding Stoichiometry Ratio by Native SEC-MS
  3. Product Stability by Forced Degradation
  4. Epitope Mapping Analysis by HDX-MS
  5. Formulation Development for Enhanced Stability (e.g., BiTE and DART)
  6. Complex Disulfide Profiling for Structure Elucidation

Advance. De-Risk. Accelerate.
From identifying and characterizing the specific molecular attributes of your platform’s conjugation sites in candidate development, to quantifying and characterizing CQAs and PTM progression in pivotal clinical trials in vivo, we will be happy to work with you, bringing our insights, experience, and method development expertise to accelerate your ADC and multispecific therapeutics programs. Contact our experts today »

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