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Related Experiment Video

Updated: Feb 16, 2026

Genetic Encoding of a Non-Canonical Amino Acid for the Generation of Antibody-Drug Conjugates Through a Fast Bioorthogonal Reaction
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Control Strategy for Small Molecule Impurities in Antibody-Drug Conjugates.

Hai H Gong1, Nathan Ihle2, Michael T Jones3

  • 1AbbVie Inc., 1 North Waukegan Rd, North Chicago, Illinois, 60064-1802, USA.

AAPS Pharmscitech
|January 6, 2018
PubMed
Summary
This summary is machine-generated.

New strategies address small molecule impurities in antibody-drug conjugates (ADCs). A science-based approach shows these impurities pose minimal safety risks due to low exposure levels in ADC therapeutics.

Keywords:
ADCcontrol strategyrisk assessmentsmall molecule impurity

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Area of Science:

  • Pharmaceutical Science
  • Biotechnology
  • Drug Development

Background:

  • Antibody-drug conjugates (ADCs) are an emerging biopharmaceutical class.
  • Existing ICH guidelines (Q3A, Q3B, Q6B) do not fully address small molecule impurities in ADCs.
  • Lack of specific guidelines necessitates a new evaluation strategy.

Purpose of the Study:

  • To present a science-based strategy for evaluating small molecule impurities in ADCs.
  • To guide the design of control systems for ADC therapeutics.
  • To address the limitations of current impurity guidelines for ADCs.

Main Methods:

  • The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) impurities working group (IWG) developed the strategy.
  • The approach considers molecular weight differences, conjugation potential, and dosing parameters.
  • A risk-based assessment focusing on impurity exposure.

Main Results:

  • The proposed strategy provides a framework for controlling small molecule impurities in ADCs.
  • Key principles include differences in molecular weight, conjugation potential, and dosing.
  • Low exposure levels of small molecule impurities in ADCs suggest minimal safety risks.

Conclusions:

  • The developed strategy offers a science-based approach for managing small molecule impurities in ADCs.
  • This approach can inform the development of robust control strategies for ADC therapeutics.
  • Current impurity assessment methods need adaptation for the unique nature of ADCs.