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Predictive Nature of High-Throughput Assays in ADC Formulation Screening.

Brittney J Mills1, Malika P Godamudunage1, Siyuan Ren1

  • 1Biologics CMC Drug Product Development, AbbVie Inc., 1 N Waukegan Road, North Chicago, IL 60064, United States.

Journal of Pharmaceutical Sciences
|April 10, 2023
PubMed
Summary

High-throughput biophysical screening accurately predicts long-term stability for antibody-drug conjugates (ADCs). Assays measuring aggregation (Tagg, B22) show strong correlation with stability, guiding formulation development.

Keywords:
Antibody-drug conjugatesDevelopability screeningHigh-throughput technologyPhysical stabilityPreformulationProtein aggregationProtein formulation

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Area of Science:

  • Biophysical Chemistry
  • Pharmaceutical Development
  • Drug Stability

Background:

  • High-throughput screening (HTS) is crucial for early drug development due to limited sample availability.
  • Predicting long-term storage stability from HTS data is essential for defining optimal formulation design spaces.
  • Antibody-drug conjugates (ADCs) require robust stability assessments for effective therapeutic development.

Purpose of the Study:

  • To evaluate the predictive capability of high-throughput biophysical screening methods for ADC formulation stability.
  • To compare the rank order of formulations from HTS assays with results from traditional long-term stability studies.
  • To determine which biophysical assays best predict colloidal and conformational stability of ADCs.

Main Methods:

  • Two ADCs were tested across 16 different formulation conditions.
  • High-throughput techniques were used to assess conformational stability (Tm) and colloidal stability (kD, B22, Tagg).
  • Samples underwent an 8-week stability study to monitor aggregate formation, with results compared to HTS data.

Main Results:

  • High-throughput assays measuring aggregation (Tagg, B22) showed rank orders similar to traditional size exclusion chromatography (SEC) data.
  • Conformational stability assays (Tm) demonstrated lower predictability for long-term stability.
  • Screening assays successfully identified poorly performing formulation conditions, aligning with desired outcomes.

Conclusions:

  • High-throughput assays like Tagg and B22 are valuable for predicting ADC aggregation and colloidal stability.
  • Conformational stability measurements (Tm) are less reliable predictors of long-term storage stability.
  • HTS biophysical methods effectively identify suboptimal formulations, supporting efficient ADC development.