Antibody stability: A key to performance - Analysis, influences and improvement

Area of Science:

• Biochemistry
• Immunology
• Biotechnology

Background:

• Antibody performance, including specificity and affinity, is significantly impacted by stability.
• The increasing application of antibodies in therapeutics, diagnostics, and analytical platforms highlights the importance of stability for researchers and manufacturers.

Purpose of the Study:

• To provide a comprehensive review of antibody stability.
• To discuss factors affecting antibody stability, including measurement techniques, production challenges, engineering strategies, and storage conditions.
• To offer recommendations for improving antibody stability.

Main Methods:

• Review of over 100 sources, including scientific literature and patents.
• Categorization of antibody stability factors into five key areas: measurement, production, engineering, formulation, and storage.
• Synthesis of information to identify common challenges and effective strategies.

Main Results:

• Stability is a critical determinant of antibody function across various applications.
• Expression, proteolysis, and aggregation are key stability issues during antibody production.
• Antibody format, engineering, formulation, drying, and storage conditions all play significant roles in maintaining stability.

Conclusions:

• Understanding and addressing antibody stability is essential for successful therapeutic and diagnostic development.
• Implementing appropriate measurement techniques, optimizing production, employing suitable engineering strategies, and controlling formulation and storage are vital.
• Proactive measures are recommended to ensure and enhance antibody stability throughout the product lifecycle.