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Related Experiment Video

Updated: Jul 15, 2025

Initial Evaluation of Antibody-conjugates Modified with Viral-derived Peptides for Increasing Cellular Accumulation and Improving Tumor Targeting
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CMC Regulatory Considerations for Antibody-Drug Conjugates.

Karoline Bechtold-Peters1, Andrea Ruggiero2, Nienke Vriezen3

  • 1Novartis Pharma AG, Basel, Switzerland.

Journal of Pharmaceutical Sciences
|September 23, 2023
PubMed
Summary

Antibody-drug conjugates (ADCs) require complex manufacturing. A risk-based approach ensures quality control and streamlines development, avoiding redundant studies for regulatory approval.

Keywords:
Antibody-drug conjugatesCytostaticDrug-linkerPayloadPoints of control

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Drug Development
  • Chemical Biology

Background:

  • Antibody-drug conjugates (ADCs) combine antibodies with potent drugs for targeted therapy.
  • ADC manufacturing involves intricate processes for antibody, drug, and linker production, followed by conjugation.
  • This complexity necessitates robust control strategies and analytical characterization.

Purpose of the Study:

  • To outline an integrated quality approach for ADC development.
  • To provide guidance on structuring Module 3 of the Common Technical Document for ADCs.
  • To address regulatory expectations for ADC process control and characterization.

Main Methods:

  • Application of scientific understanding of ADC production processes.
  • Implementation of risk-based approaches to quality management.
  • Analysis of regulatory documentation requirements for ADCs.

Main Results:

  • A risk-based strategy can demonstrate quality at critical control points.
  • This approach minimizes redundant comparability studies and product characterization.
  • Streamlined process qualification focusing on critical quality attributes is enabled.

Conclusions:

  • Integrated quality management is essential for complex ADC manufacturing.
  • Flexible structuring of regulatory documents is feasible with adequate cross-referencing.
  • A risk-based approach facilitates efficient and compliant ADC development throughout the product lifecycle.