Measuring the aggregation of CHO cells prior to single cell cloning allows a more accurate determination of the probability of clonality

Author:

Klottrup Kerensa J.1ORCID,Miro-Quesada Guillermo2,Flack Layla3,Pereda Ivan4,Hawley-Nelson Pamela5

Affiliation:

1. Cell Culture and Fermentation Sciences; Biopharmaceutical Development, MedImmune; Cambridge CB21 6GH UK

2. Data Management and Quantitative Sciences; Biopharmaceutical Development, MedImmune; Gaithersburg MD 20878

3. Artimis Federal; Gaithersburg MD 20878

4. R&D Informatics, AstraZeneca; Cambridge CB21 6GH UK

5. Cell Culture and Fermentation Sciences; Biopharmaceutical Development, MedImmune; Gaithersburg MD 20878

Publisher

Wiley

Subject

Biotechnology

Reference39 articles.

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

2. N-linked glycosylation is an important parameter for optimal selection of cell lines producing biopharmaceutical human IgG;Berkel;Biotechnol Prog.,2009

3. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5D/Step4/Q5D_Guideline.pdf 2016

4. 2013 http://www.who.int/biologicals/biotherapeutics/rDNA_DB_final_19_Nov_2013.pdf

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

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