Noelle Sunstrom
NeuClone PTY, Ltd, Australia
Title: Cell line development for the production of biosimilar monoclonal antibodies with high target bioactivity and high productivity
Biography
Biography: Noelle Sunstrom
Abstract
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 quantityto ensure the project is economically viable, and (2) the molecule expressedmust behighly 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 riskof 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.