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Initial Evaluation of Antibody-conjugates Modified with Viral-derived Peptides for Increasing Cellular Accumulation and Improving Tumor Targeting

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Antibody-Drug Conjugates Drug Product Formulation and Process Development, Scalability and Stability Considerations.

Léa Sorret¹, Mamiko Ninomiya², Nils Hillebrandt³

¹Drug Product Formulation Development, Lonza AG, Hochbergerstrasse 60G, 4057, Basel, Switzerland.

AAPS Pharmscitech

|June 4, 2026

Summary

Antibody-drug conjugates (ADCs) require specialized formulation and process development due to their complexity. This review details strategies for ADC drug product development, stability, and scalability, addressing key challenges for therapeutic success.

Keywords:

antibody–drug conjugates drug product formulation development lyophilization process development

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Published on: September 14, 2018

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Published on: March 8, 2018

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Genetic Encoding of a Non-Canonical Amino Acid for the Generation of Antibody-Drug Conjugates Through a Fast Bioorthogonal Reaction

Genetic Encoding of a Non-Canonical Amino Acid for the Generation of Antibody-Drug Conjugates Through a Fast Bioorthogonal Reaction

Published on: September 14, 2018

Area of Science:

Biopharmaceutical Development
Drug Product Manufacturing
Conjugation Chemistry

Background:

Antibody-drug conjugates (ADCs) merge targeted antibody delivery with potent cytotoxic payloads for enhanced cancer therapy.
The complex structure of ADCs (antibody, linker, payload) presents unique challenges in drug product (DP) development, stability, and manufacturing.
Maintaining the target product profile throughout the ADC lifecycle necessitates tailored formulation and process strategies.

Purpose of the Study:

To review critical formulation and process development considerations specific to ADC drug products.
To discuss degradation risks (photo-, heat-induced) and strategies for mitigation through formulation and packaging.
To provide insights into analytical tools, lyophilization, Quality by Design (QbD), and scale-up control strategies for ADCs.

Main Methods:

Literature review of formulation and process development for ADCs.
Discussion of degradation pathways and mitigation strategies.
Exploration of analytical techniques, lyophilization, QbD, and scale-up considerations.

Main Results:

Identification of key degradation risks and their management through excipient and packaging selection.
Recommendations for lyophilization strategies using Design of Experiments and modeling.
Emphasis on QbD principles and risk-based approaches for robust ADC process control.

Conclusions:

Successful ADC development hinges on addressing unique formulation and process challenges.
Evolving control strategies are crucial for transitioning ADCs from early development to commercialization.
This review offers practical strategies for navigating ADC drug product development complexities.