Osmolality, a Critical Quality Attribute for Cell Line Development and Cell Therapy

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. Where osmolality is too high, or too low, production yields and cell viability can be affected, or even an entire batch can be lost. Frequent measurement of osmolality is therefore a crucial component to effect process design.

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. Earlier implementation establishes good working practices and can 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.

Speakers

Dr. Mark Rothenberg, Associate Director in Scientific Applications, Advanced Instruments

Mark Rothenberg earned his Ph.D. in Cell and Developmental Biology from Emory University in Atlanta, Georgia, and a M.S. in Biology from the University of Denver. Mark has thirty years of experience in the biotechnology industry, with an expertise in the areas of cell culture, including scale-up and small-scale biologic production and assay development. Mark has a broad history in biotech, working as a gene hunter in Metabolic disease to leading a team of Application scientists at Cytiva. Mark’s current role at Advanced Instruments is that of Associate Director of Scientific Applications.

Message Presenter

Dr. Ian Taylor, Director of Business Development, Advanced Instruments, Solentim

Ian Taylor obtained a First Class Degree and PhD in Biochemistry from the University of Southampton. From University, Ian completed a formal business and accountancy training at KPMG.

Ian has more than 30 years working in the conceptualisation and commercialisation of novel high value life-sciences instrumentation, some of which have gone on to make significant contributions in the development of successful new biologics. Ian has been with Solentim since it was founded in 2010. Prior to that, he was part of the senior leadership team for PerkinElmer Life Sciences and Chief Commercial Officer at Genetix PLC.

In Ian’s new role with Advanced Instruments he will be largely focussing on technologies for gene therapy and cell therapy.

Message Presenter