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Cell Lines

Cell Lines

A cell line is a population of cells grown in vitro that can be subcultured over several generations. Normal cells cease to divide after a certain number of cell divisions, a process known as replicative senescence. This number, called the Hayflick limit, was conceptualized by Leonard Hayflick in 1961 when he observed that fetal cells grown in culture could only divide 40-60 times. This limit is due to the shortening of the telomeres during each round of cell division, preventing cell division...

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Updated: Jan 1, 2026

Clonogenic Assay: Adherent Cells

Clonogenic Assay: Adherent Cells

Published on: March 13, 2011

Methods for Estimating the Probability of Clonality in Cell Line Development.

Chun Chen¹, Kim Le¹, Huong Le¹

¹Drug Substance Technologies, Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.

Biotechnology Journal

|December 17, 2019

Summary

This review compares methods for estimating the probability of clonality (PoC) in mammalian cell banks for biopharmaceutical production. Standardizing PoC estimation is crucial for comparing cloning workflows and accelerating regulatory approval.

Keywords:

cell line development clonality imaging limiting dilution probability of clonality

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Last Updated: Jan 1, 2026

Clonogenic Assay: Adherent Cells

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Published on: March 13, 2011

Characterizing Mutational Load and Clonal Composition of Human Blood

Characterizing Mutational Load and Clonal Composition of Human Blood

Published on: July 11, 2019

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics

Published on: September 22, 2011

Area of Science:

Biopharmaceutical Manufacturing
Cell Line Development
Molecular Biology

Background:

Mammalian cell banks are critical for biopharmaceutical production, typically originating from a single progenitor cell.
Ensuring clonal origin is essential for product consistency and regulatory compliance.
Various methods exist to estimate the probability of clonality (PoC) for cell banks.

Purpose of the Study:

To systematically analyze and compare existing methods for calculating the PoC.
To highlight the need for a standardized approach to PoC estimation.
To facilitate the comparison of different cloning workflows in the biopharmaceutical industry.

Main Methods:

Systematic literature review and analysis of PoC calculation methods.
Comparative assessment of methodologies based on reported data and technological advancements.
Discussion of the impact of evolving single-cell deposition and imaging technologies.

Main Results:

A comprehensive overview of current PoC estimation techniques is presented.
Identified variations and limitations in existing methods.
Highlighted the growing importance of accurate PoC determination with technological advancements.

Conclusions:

An aligned understanding and best practice for PoC estimation are necessary.
Standardized PoC assessment will enable effective comparison of cloning workflows.
Improved PoC estimation will accelerate regulatory acceptance for biopharmaceutical production.