Statistical analysis of data from limiting dilution cloning to assess monoclonality in generating manufacturing cell lines

Author:

Quiroz Jorge1,Tsao Yung-Shyeng2

Affiliation:

1. BARDS, Research CMC Statistics, Merck Research Laboratories; Kenilworth NJ 07033 USA

2. Department of Bioprocess Technology Expression; Biologics and Vaccines, Merck Research Laboratories; Kenilworth NJ 07033 USA

Publisher

Wiley

Subject

Biotechnology

Reference12 articles.

1. European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on production and quality control of monoclonal antibodies and related substances 2007

2. Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/biological Products 1997

3. Assurance of monoclonality in one round of cloning through cell sorting for single cell deposition coupled with high resolution cell imaging;Evans;Biotechnology Prog,2015

4. Advances in mammalian cell line development technologies for recombinant protein production;Lai;Pharmaceuticals,2013

5. Statistical analysis of repetitive subcloning by the limiting dilution technique with a view torward ensuring hybridoma monoclonality;Coller;Hybridoma,1983

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