Methods for Estimating the Probability of Clonality in Cell Line Development
| Autor: | Kim Le, Kristi Daris, Jennitte Stevens, Neil Soice, Huong Le, Chun Chen, Chetan T. Goudar |
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| Rok vydání: | 2020 |
| Předmět: |
Mammals
0106 biological sciences Biological Products Drug Industry Cloning (programming) Computer science Cloning Organism 010401 analytical chemistry General Medicine Computational biology 01 natural sciences Applied Microbiology and Biotechnology Cell Line Clone Cells 0104 chemical sciences Biopharmaceutical industry Workflow Biopharmaceutical 010608 biotechnology Limiting dilution Mammalian cell Animals Humans Molecular Medicine Line (text file) |
| Zdroj: | Biotechnology Journal. 15:1900289 |
| ISSN: | 1860-7314 1860-6768 |
| DOI: | 10.1002/biot.201900289 |
| Popis: | Mammalian cell banks for biopharmaceutical production are usually derived from a single progenitor cell. Different methods to estimate the probability that the cell banks are clonally derived, or the probability of clonality (PoC), associated with various cloning workflows have been reported previously. In this review, a systematic analysis and comparison of the methods used to calculate the PoC are provided. As the single cell deposition and high-resolution imaging technologies continue to advance and the cloning workflow evolves, an aligned understanding and best practice on estimating the PoC is necessary to compare different cloning workflows adopted across the biopharmaceutical industry and it will help to accelerate regulatory acceptance. |
| Databáze: | OpenAIRE |
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