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Hybridoma Technology

Hybridoma Technology

Hybridoma technology is used for the large-scale production of monoclonal antibodies. Monoclonal antibodies bind to only a single antigenic determinant or epitope. Such antibodies are used in research, diagnostics, and disease therapy. The hybridoma technology established in 1975 by Georges Köhler and Cesar Milstein was awarded the Nobel Prize in Medicine in 1984 for revolutionizing research and therapy.
Hybridoma Selection
Commonly used fusion techniques — electroporation,...

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Related Experiment Video

Updated: Nov 17, 2025

Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System

Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System

Published on: May 1, 2019

Stability testing in monoclonal antibodies.

¹Analytical Sciences, Aurobindo Biologics, Hyderabad, India.

Critical Reviews in Biotechnology

|February 18, 2021

Summary

This summary is machine-generated.

Monoclonal antibody (mAb) stability is crucial for therapeutic development. This review covers manufacturing, degradation factors, analytical methods, and ICH guidelines for mAb stability testing.

Keywords:

regulatory guideline Monoclonal antibodies aggregation stability therapeutics

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Last Updated: Nov 17, 2025

Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System

Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System

Published on: May 1, 2019

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Published on: September 15, 2023

Capillary Electrophoresis Separation of Monoclonal Antibody Isoforms Using a Neutral Capillary

Capillary Electrophoresis Separation of Monoclonal Antibody Isoforms Using a Neutral Capillary

Published on: January 16, 2017

Area of Science:

Biopharmaceutical Development
Protein Chemistry
Analytical Chemistry

Background:

Monoclonal antibodies (mAbs) are vital therapeutics but prone to instability.
Ensuring mAb stability is a critical regulatory requirement for drug development and commercialization.

Purpose of the Study:

To review mAb manufacturing processes and factors influencing their stability.
To highlight analytical techniques for mAb stability assessment.
To discuss International Council for Harmonisation (ICH) guidelines for biological product stability.

Main Methods:

Review of upstream processing, downstream purification, and aseptic filling.
Analysis of physical and chemical factors (pH, temperature, oxidation, etc.) affecting mAb stability.
Examination of various analytical techniques for stability studies.

Main Results:

Identified key manufacturing stages and environmental factors contributing to mAb instability.
Detailed various analytical methods for investigating mAb degradation pathways.
Provided insights into developing stability-indicating methods for mAbs.

Conclusions:

Comprehensive understanding of mAb instability factors is essential.
Appropriate analytical techniques and adherence to ICH guidelines are critical for robust stability testing.
Effective stability assessment ensures the safety and efficacy of therapeutic monoclonal antibodies.