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Apheresis for cellular therapy manufacturing: need for improved collection data

February 8th, 2016 |

Melbourne 8 Feb 2016: Cell collection via apheresis is the starting point for manufacture of many cellular therapies, including most immuno-therapies. The high patient-to-patient variability, coupled with the specialised skills needed for these collections mean manufacturers have to deal with significant variation in incoming cellular material. Manufacturers are only now coming to grips with the implications of this variation, let alone how to manage and control it. Cell Therapies Pty Ltd CEO Tim Oldham discussed the importance of understanding apheresis variability and approaches to managing and controlling it at the recent Cell & Gene Therapy Leaders Forum in Washington DC (see the presentation Managing apheresis as source of cellular therapy starting material) and Alexey Bersenev has followed up with a useful blog at Stem Cell Assays (http://stemcellassays.com/2016/01/standardization-of-apheresis-collections-for-cell-product-manufacturing/#comments). Dr Oldham argued that collating collection data across many centres and collections to enable apheresis variability to be characterized and understood, and to benchmark individual site, operator and collection performance would be an invaluable tool to aid manufacturing process development.