Noelle Sunstrom, Angelo Perani, Sarah McCaig, Caroline Ferrari, Brendan Broome and Adrian Cawley
NeuClone PTY, Ltd, Australia
Posters & Accepted Abstracts: J Bioanal Biomed
The cell line development group at NeuClone generates high quality cell lines for the production of biosimilar monoclonal antibodies (mAbs). Two characteristics are required to ensure the successful generation of a biosimilar production cell line � (1) the recombinant molecule must be expressed in sufficient quantity to ensure the project is economically viable, and (2) the molecule expressed must be highly similar in structure and activity to the originator molecule. Traditionally the selection of cell lines expressing antibodies has been based on the selection of high producing mini-pools of cells that are subsequently further enriched for production by either limiting dilution cloning, clone-picking in semi-solid medium or by single-cell fluorescence-activated cell sorting. Clones are then expanded and evaluated in laboratory scale bioreactors to determine the best process development parameters prior to production scale up that will generate purified material for further product characterisation. The biological activity of a biosimilar mAb should mimic the originator in all aspects in order to achieve biosimilarity, including target binding and various effector functions such as signalling, cell death, proliferation, etc. We have designed a strategy that concurrently screens mini-pools and clones at an early stage for productivity as well as biosimilarity. This novel quality by design approach aims to minimise the risk of isolating high producing clones with insufficient biosimilarity early on� thus reducing the time in identifying clones with high productivity and with the right biosimilar attributes.
Email: n.sunstrom@neuclone.com
Journal of Bioanalysis & Biomedicine received 3099 citations as per Google Scholar report
Spanish 
Chinese 
Russian 
German 
French 
Japanese 
Portuguese 
Hindi 