The Collectables: Year in Bioanalysis
Editorial: Ready-to-use cells in bioassays for quality control of biopharmaceuticals
C Jane Robinson, PhD; Scientific Liaison, Biopharmaceutical Emerging Best Practices Association; Email:
Jane.Robinson@
bebpa.org
Jane Robinson is Scientific Liaison for the Biopharmaceutical Emerging Best Practices Association (CA, USA) a non-profit organization for the presentation and discussion of scientific issues to facilitate safer and faster biopharmaceutical product development. She has a particular interest in the development of in vitro bioassays. Previously, she worked for 25 years at the National Institute for Biological Standardization and Control (UK), where she was responsible for the establishment of a laboratory for the standardization and control of polypeptide growth factors and related molecules of therapeutic and diagnostic potential.
Jane Lamerdin, PhD; Director, R&D, DiscoverX Corp; Email:
jlamerdin@discoverx.com
Jane Lamerdin, currently Director of R&D in the Enzyme Fragment Complementation division of DiscoverX (CA, USA), oversees the development of novel cell-based assays for discovery as well as bioassays for lot release and neutralizing antibody applications. Jane has over 16 years of experience developing cell-based assays to support drug discovery and systems biology research. Prior to joining DiscoverX, she was Executive Director of R&D at Odyssey Tera (CA, USA), where she played a key role in the implementation of a systems biology approach to characterize safety and selectivity of client molecules by utilizing a diverse high content cell-based assay panel.
Keywords: Ready-to-use cells, assay-ready cells, cell-based bioassay, potency assay, quality control Introduction
A bioassay for potency measurement is a regulatory requirement for release testing for most biopharmaceuticals and is an essential tool throughout the drug development and production process. Cell-based assays are widely used for this purpose. Genetic modification of cell lines offers an increasing range of options for ligand specificity, measured cellular response and readout platforms. However, the common practice of maintaining cells in continuous culture, and harvesting some as required for use in an assay, presents a number of disadvantages. Similarly, primary cells, required for some assays, present challenges in their preparation. Many problems can be avoided if there is the possibility of taking a vial of ‘ready-to-use’ cells from a frozen bank of uniform, tested, aliquots and utilizing this directly in an assay.
Cell-based assays
For cell-based assays utilizing immortalized cell lines, historical practice has generally been to thaw a frozen aliquot of cells, then culture for a specified number of population doublings, or passages, to allow the cells to stabilize before they are used in an assay. Cells are then harvested, as required, from the continuous culture, up to a specified passage limit. Tis limit has to be set because most cells do not maintain their characteristics indefinitely in continuous culture and, beyond a validated passage number, their response in an assay may drift outside acceptable limits. Such continuous culture requires considerable resources:
• Expensive consumables such as media and culture ware • Labor time for cell culturing and record keeping • Dedicated equipment such as incubators • Laboratory space • Infrastructure such as gas supplies, environmental monitoring systems, waste disposal
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