Osmolality measurement prior to seeding and frequent monitoring through cell line development can contribute both as a process control mechanism and a critical quality attribute for selection.
TORONTO (PRWEB)
October 07, 2021
Osmolality, the measurement of dissolved solutes in media, is a well-established critical quality and process control measure within bioproduction of therapeutic antibodies and in cell therapy. With the advent of easier to use, cheaper and higher throughput methods, assays traditionally only used in later stages of bioproduction are being adopted in the earlier process development stages, which can establish good working practices and contribute to process control.
Within the cell line development or cell therapy development, process pools of transfected cells are brought back to a single cell (‘clonal’) stage then grown back up into colonies prior to selection based on critical quality attributes (CQA), with the aim of controlling pool heterogeneity and identifying clones with desirable traits. In addition to evidence of clonality, selection of clones to bank commonly use productivity (yield per cell per time), viable cell density and product stability. In addition to these, osmolality measurement prior to seeding and frequent monitoring through cell line development can contribute both as a process control mechanism and a critical quality attribute for selection.
In this presentation, the use of osmolality in bio-production and in earlier process development will be discussed. The case will be made for more frequent, earlier monitoring in cell line development and cell therapy.
Join experts from Advanced Instruments / Solentim, Mark Rotheberg, PhD, Associate Director in Scientific Applications and Ian Taylor, PhD, Director of Business Development, for the live webinar on Wednesday, October 27, 2021 at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Osmolality, a Critical Quality Attribute for Cell Line Development and Cell Therapy.
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