Result: We collected 10 granulocyte products from 4 donors, 3 males, median age 34 years (range 31-35). All 4 donors tolerated the collection well, two donors experienced minor hypotensive episodes. The characteristics [median (range)] of the 10 collection episodes were; donor pre white cell count 29.3Â10 9 /L (8.8-37.2); total blood volume processed 7972 mL (6000- 9884 mL); procedural time 153.5 minutes (104-200); product volume 450 mL (242-670; neutrophil count 3.31Â10 10 /L (0.87-92.22Â10 10 /L); neutrophil increment 0.12Â10 9 /L(0-0.32Â10 9 /L). Conclusion: Granulocytes collected using TerumoBCT Optia Ò were successful in treating our patient with HCL and severe poly microbial sepsis. A transfusible dose was achieved in all donations. Retrospective comparison with historical collections (Cobe Spectra/Dextran 70%) and maximisation of collection efficiency are pending. 180 QUALIFICATION OF THE COSTIM ASSAY TO DETERMINE POTENCY AND USE IN CLINICAL TRIALS M Buchholz 1 , J Knauer 2 , J Lehmann 2 , M Hass 2 , S Gargosky 3 1 Prima BioMed GmbH, Leipzig, Germany, 2 Fraunhofer-Institute for Cell Therapy and Immunology IZI, Leipzig, Germany, 3 Prima BioMed Ltd, Redwood City, CA Potency is one of the key quality control criteria for batch release of a drug for pharmaceutical use. We have undertaken the qualification of a potency bioassay for our product Cvac, an autologous dendritic cell pulsed with recombinant human mucin 1 fusion protein. The challenge with bioassays for cellular therapies is the inherent individual variability as well as the complexity of assessing a biological system. Functionally, dendritic cells (DC) activate T cells in vivo by presenting a T cell with a specific antigen which results in T cell proliferation and release of cytokines. T cell stimulation and proliferation (DNA synthesis) can be assessed. The COSTIM-assay published by Shankar et al. (2004) was foundational in the assay development. Additional work undertaken to optimise the assay included assessment of washing techniques, DC:T cell ratios, BrdU-incubation time and stopping, as well as the measurement systems. Product was co-cultured with suboptimal stimulated (aCD3) T cells (COSTIM). Product co-cultured with T cells in the absence of aCD3 (MLR) and T cells alone suboptimal stimulated with aCD3 served as negative controls. Five different Cvac batches were used in the testing on three consecutive days. Every sample was measured in five replicates per day. The intra assay precision (well to well variation within plate) of raw data showed an average coefficient of variation (CV) of 9.02% (Range of 1.4 to 21.9%) while mean CV for stimulation index (COSTIM/MLR) was 13.24% (Range 4.3 to 23.8%). The inter day precision (day-to-day variation within analyst) showed an average CV of 12.82% (Range 2.4 to 25.9%) and 19.82% (Range 6.4 to 30.6%) for raw data and stim- ulation index respectively. This assay is being applied to patient samples of the CANVAS clinical trial with the goal of evaluating potency in vitro with long term clinical outcomes. 181 STEMVISIONÔ: A BENCH-TOP INSTRUMENT FOR AUTO- MATED AND STANDARDIZED COUNTING OF ALL HEMATOPOIETIC COLONY TYPES IN CFU ASSAYS OF HUMAN BONE MARROW, CORD BLOOD AND MOBILIZED PERIPHERAL BLOOD CELLS O Egeler, C Grande, N Yuan, B Wognum, S Woodside, A Booth, SJ Szilvassy, T Thomas, AC Eaves STEMCELL Technologies Inc., Vancouver, BC, Canada The colony-forming unit (CFU) assay is the most reliable in vitro method to enumerate hematopoietic progenitor cells in human blood or bone marrow (BM). In this assay, progenitors cultured in cytokine-supplemented MethoCultÔ medium produce colonies of mature blood cells that are counted after 1-2 weeks. Typically, colonies generated by lineage-restricted or multi-potential progenitor cells are scored manually using an inverted microscope according to morpho- logical criteria that can be difficult to apply consistently. This subjectivity can cause high intra/inter-individual and -laboratory variation in assay results. To improve the accuracy and reproducibility of the human CFU assay, we have developed an instrument, STEMvisionÔ, that uses image analysis software to identify, classify and count colonies produced by erythroid, myeloid and multi-potential progenitors in BM, cord blood (CB), and mobilized peripheral blood (MPB). Automated colony counts in 14-day CFU assays were highly correlated with manual counts. For BM assays (n¼163) the correlation coeffi- cients (r 2 ) for total CFU, BFU-E and CFU-G/M/GM were 0.88, 0.63 and 0.83, respectively. The r 2 values for automated and manual counts of total CFUs, BFU- E and CFU-G/M/GM in CB and MPB cell assays were 0.94, 0.91 and 0.81 (CB, n¼52) and 0.98, 0.96 and 0.93 (MPB, n¼129), respectively. For CFU-E and CFU-GEMM that are too rare to facilitate such statistical analysis, STEMvisionÔ counts were comparable to manual counts produced by 2-7 expert technicians who scored w50 BM, CB and MPB assays. Importantly, STEMvisionÔ colony counts were more reproducible than manual counts: coefficient of variation (CV) ¼ 5% for total colonies in a 14-day CFU assay of CB vs. z 25% as reported for NMDP laboratories and 11% among STEMCELL Technologies staff. The improved speed, accuracy and reproducibility of human CFU assays scored using STEMvisionÔ facilitates standardization of the assay for research and clinical laboratories, and cord blood banks. 182 CELL THERAPY DISTRIBUTED MANUFACTURING, MAN- AGING COSTS AND RISKS MJ McCall, DJ Williams Loughborough University, Loughborough, United Kingdom Comparability (demonstration of product equivalence) is required after a process change, when a second facility or location or new raw material is brought on stream or when multiple sites of manufacture are created. The ability to demonstrate comparability across multiple sites is critical to allow process improvement, secure economies of scale and scope and enable supply of equivalent cell therapies at acceptable costs in order to reach patients in multiple markets and locations. Solution of the problem hinges on satisfying the regulator of the compa- rability between manufacturing sites. This work presents a cost model that quantifies the financial impact of defining and meeting an acceptable regulatory burden at an early stage in order to inform decisions in the product develop- ment process. This work quantifies the cost, time and risk associated with establishing multiple sites of manufacturing for cell therapy products. A scenario and rules based mixed-integer linear programming (MILP) formulation is presented for capacity planning in multi-markets that takes account of adoption and clinical trials outcome uncertainty. Results show the financial and temporal cost of build, validating and operating multiple sites of manufacture. The model takes account of initial validation costs for each facility and the ingoing burden of comparability demonstration. High impact areas are the interdependence of product shelf life (and distribution potential) and the number of sites needed to satisfy a global market. An application comparing alternatives to satisfying the regulatory burden of demonstrating comparability across multiple sites indicates that the currently anticipated requirements to measure the manufacturing and characterisation outputs of each site against each other site including the sourcing of additional clinical data is highly resource intensive and strategies for managing this are highlighted. This work arose from the VALUE TSB, project and was co-funded by the EPSRC Doctoral Training Centre in Regenerative Medicine. 183 THE REGULATION OF ADVANCED THERAPY MEDICINAL PRODUCTS IN EUROPE AND THE ROLE OF ACADEMIA KF Pearce 1 , MO Hildebrandt 2 , S Scheding 3 , U Köhl 4 , E Mischak-Weissinger 4 , A Hauser 5 , M Edinger 5 , H Greinix 6 , N Worel 6 , J Apperley 7 , MW Lowdell 8 , AM Dickinson 1 1 Institute of Cellular Medicine, Medical School, University of Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom, 2 TUMCells, Technical Univerity Munich, Munich, Germany, 3 Lund University, Stem Cell Center, Sweden, Lund, Sweden, 4 Hannover Medical School (MHH), Hannover, Germany, 5 University Hospital, Jose Carreras Center, Regensburg, Germany, 6 Medizinische Universitaet Wien, Vienna, Austria, 7 Imperial College, London, United Kingdom, 8 University College, London, United Kingdom Advanced Therapy Medicinal Products (ATMPs) are medicinal products based on gene therapy, somatic cell therapy or tissue engineering. Regulation (EC) No 1394/2007 has been designed to ensure their free movement within the European 19th Annual ISCT Meeting S51