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Related Experiment Video

Updated: May 30, 2025

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

Effect of formulation composition on trastuzumab stability.

Aziz Ahmad¹, Hesham Refaat², Sanghati Bhattacharya²

¹Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, MN 55455, United States.

International Journal of Pharmaceutics

|January 27, 2025

Summary

Formulation composition significantly impacts monoclonal antibody aggregation, not conformational stability, during stress. Sucrose formulations increased soluble aggregates after freeze-drying, while sorbitol formulations increased insoluble aggregates upon agitation.

Keywords:

Aggregation Agitation Biosimilar Conformational stability Freeze-drying Freeze–thaw Innovator Trastuzumab

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Published on: November 27, 2016

Area of Science:

Biopharmaceutical formulation
Protein stability and aggregation

Background:

Biosimilar monoclonal antibodies often have different formulations than innovator products.
The impact of formulation on drug product stability under stress is not fully understood.

Purpose of the Study:

To evaluate how different formulations affect the structural stability and aggregation of trastuzumab (a monoclonal antibody) under common stresses.
To understand the role of formulation composition in mitigating or exacerbating stress-induced changes.

Main Methods:

Trastuzumab (drug substance and drug product) was formulated with different stabilizers (sucrose, sorbitol, trehalose).
Formulations were subjected to freeze-thaw, freeze-drying, and agitation stresses.
Conformational stability and aggregation (soluble and insoluble) were analyzed.

Main Results:

All formulations showed good conformational stability against the tested stresses.
Freeze-drying increased soluble aggregates in sucrose-containing formulations.
Agitation increased insoluble aggregates in sorbitol-containing formulations, potentially due to surfactant absence.
Trehalose demonstrated concentration-independent stabilization.

Conclusions:

Formulation composition has a greater impact on monoclonal antibody aggregation than on conformational stability.
Effective formulation design for biologics requires careful consideration of both stability and aggregation behavior.