PT  - JOURNAL ARTICLE
AU  - Zingaro, Kyle
AU  - Shaw, David
AU  - Carson, Jerry
AU  - Mayer-Bartschmid, Anke
AU  - Bender, Christian
AU  - Alves, Christina
AU  - McVey, Duncan
AU  - Quan, Nan-xin
AU  - Wei, Quinxiang
AU  - Laird, Mike
AU  - Zhu, Yuan
AU  - Emmins, Robyn
AU  - Follit, John
AU  - Porter, Alison
AU  - Racher, Andrew J
AU  - Milne, Sarah
AU  - Carubelli, Ivan
AU  - Du, Zhimei
AU  - Khatri, Ankita
AU  - Failly, Marilyne
AU  - Broly, Herve
AU  - Lee, Frank
AU  - Reeser, Matthew
AU  - Spirel, Jared
AU  - Anderson, Karin
AU  - DeMaria, Christine
AU  - Di-Carlo, Jennifer
AU  - Gill, John
AU  - Lundquist, Amie
AU  - Kumar, Sampath R
AU  - Gill, Tony
TI  - Implementation of Plate Imaging for Demonstration of Monoclonality in Biologics Manufacturing Development
AID  - 10.5731/pdajpst.2018.008789
DP  - 2018 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2018.008789
4099  - http://journal.pda.org/content/early/2018/04/16/pdajpst.2018.008789.short
4100  - http://journal.pda.org/content/early/2018/04/16/pdajpst.2018.008789.full
AB  - Monoclonality of mammalian cell lines used for production of biologics is a regulatory expectation and one of the attributes assessed as part of a larger process to ensure consistent quality of the biologic. Historically, monoclonality has been demonstrated through statistics generated from limiting dilution cloning or through verified flow cytometry methods. A variety of new technologies are now on the market with the potential to offer more efficient and robust approaches to generating and documenting a clonal cell line. Here we present an industry perspective on approaches for the application of imaging and integration of that information into a regulatory submission to support a monoclonality claim. These approaches represent the views of a consortium of companies within the BioPhorum Development Group and include case studies utilising imaging technology which apply scientifically sound approaches and efforts in demonstrating monoclonality. By highlighting both the utility of these alternative approaches and the advantages they bring over the traditional methods, as well as their adoption by industry leaders, we hope to encourage acceptance of their use within the biologics cell line development space and provide guidance for regulatory submission using these alternative approaches.