A single-step FACS sorting strategy in conjunction with fluorescent vital dye imaging efficiently assures clonality of biopharmaceutical production cell lines

Author:

Fieder Jürgen1,Schulz Patrick2,Gorr Ingo1,Bradl Harald2,Wenger Till3

Affiliation:

1. Early Stage Bioprocess Development; Boehringer Ingelheim GmbH & Co. KG; Biberach Germany

2. Cell Culture Development CMB; Boehringer Ingelheim GmbH & Co. KG; Biberach Germany

3. Global NBE/Biosimilar CMC experts; Boehringer Ingelheim GmbH & Co. KG; Biberach Germany

Publisher

Wiley

Subject

Molecular Medicine,Applied Microbiology and Biotechnology,General Medicine

Reference9 articles.

1. European Medicines Agency Guideline on development, production, characterisation and specification for monoclonal antibodies and related products 2016

2. CHO quasispecies - implications for manufacturing processes;Wurm;Processes,2013

3. Industry view on the relative importance of ”clonality“ of biopharmaceutical-producing cell lines;Frye;Biologicals,2016

4. Poisson statistical analysis of repetitive subcloning by the limiting dilution technique as a way of assessing hybridoma monoclonality;Coller;Methods Enzymol.,1986

5. A statistical approach to determine monoclonality after limiting cell plating of a hybridoma clone;Lietzke;J. Immunol. Methods,1985

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