BCRT researchers develop a model to estimate manufacturing costs of Advanced Therapy Medicinal Products (ATMP)

6. Juni 2013
The “Clean-Room Technology Assessment Technique” (CTAT) was developed by BCRT researchers and was tested in two GMP facilities (at BCRT, Berlin, Germany and at University of California-Davis, Ca., USA). According to Mohamed Abou-El-Enein of BCRT, CTAT enables researchers to accurately estimate the manufacturing costs of GMP-grade cell-based products and to optimize the performance of academic GMP facilities. The model identifies activities with strong correlation to the GMP manufacturing process and measures their respective costs using a micro-costing approach. The model then categorizes the manufacturing activities into two levels: 1st, operational level (represents fixed costs) and, 2nd, production level (represents variable costs). The share of fixed operating costs in the final product can act as an indicator for the efficiency of the manufacturing process. The results suggest that the model has the capability to predict hidden costs especially when compared to traditional business models. Additionally, CTAT may push the manufacturers to move from “average” performance to “best practice” which can reduce costs significantly. Therefore, the translation of the extremely expensive GMP grade cell-based products into clinical practice could greatly benefit from the application of this model.

Contact: Mohamed Abou-El-Enein, BCRT (Clinical Development & Regulatory Affairs), Charité University Medicine, Berlin, Germany. Email: mohamed.abou-el-enein@charite.de

ISSN 1465-3249 Copyright _ 2013, International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved. dx.doi.org/10.1016/j.jcyt.2012.09.006

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