Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: a novel tailored model for optimizing performance and estimating costs |
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Authors: | Mohamed Abou-El-Enein Andy Römhild Daniel Kaiser Carola Beier Gerhard Bauer Hans-Dieter Volk Petra Reinke |
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Institution: | 1. Tissue Engineering Laboratory, Bioengineering Area, Instituto Biodonostia, Hospital Universitario Donostia, San Sebastián, Spain;2. Cell and Gene Therapy Unit, Hospital Universitario Reina Sofía, IMIBIC, Universidad de Córdoba, GMP Network of the Andalusian Initiative for Advanced Therapies, Córdoba, Spain;3. Andalusian Initiative for Advanced Therapies, Junta de Andalucía, Sevilla, Spain;4. Advanced Cellular Therapy Laboratory, Department of Cellular Therapy and Hematology, San Bortolo Hospital, Vicenza, Italy;5. Cell Factory, Unit of Cell Therapy and Cryobiology, Fondazione IRCCS Ca'' Granda Ospedale Maggiore Policlinico, Milano, Italy;6. Cell Therapy Unit, Blood Bank of Malaga, Servicio Andaluz de Salud, GMP Network of the Andalusian Initiative for Advanced Therapies, Málaga, Spain;7. Cell Therapy Unit, Hospital Universitario Regional de Málaga, IBIMA, GMP Network of the Andalusian Initiative for Advanced Therapies, Málaga, Spain;8. Cell Therapy and Tissue Engineering Unit, Complejo Hospitalario de Granada, GMP Network of the Andalusian Initiative for Advanced Therapies, Granada, Spain;9. Cell Therapy Unit, Blood Bank of Seville, Servicio Andaluz de Salud, GMP Network of the Andalusian Initiative for Advanced Therapies, Sevilla, Spain;10. Cell Therapy and Cell Reprogramming Unit, Consejería de Salud, GMP Network of the Andalusian Initiative for Advanced Therapies, Seville, Spain;11. Andalusian Transplant Coordination, Servicio Andaluz de Salud, Sevilla, Spain;1. Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Universitätsklinikum Erlangen, Department of Dermatology, Germany;2. Miltenyi Biotec GmbH, Bergisch Gladbach, Germany;3. Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Universitätsklinikum Erlangen, Department of Transfusion Medicine and Haemostaseology, Erlangen, Germany;1. Centre for Cell, Gene & Tissue Therapeutics, Royal Free Hospital, London, UK;2. Center for Cancer and Immunology Research, Center for Cancer and Blood Disorders, Children''s Research Institute, Children''s National Medical Center and The George Washington University, Washington, DC, USA;3. Department of Haematology, Cancer Institute, University College London, London, UK |
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Abstract: | Background aimsAdvanced therapy medicinal products (ATMP) have gained considerable attention in academia due to their therapeutic potential. Good Manufacturing Practice (GMP) principles ensure the quality and sterility of manufacturing these products. We developed a model for estimating the manufacturing costs of cell therapy products and optimizing the performance of academic GMP-facilities.MethodsThe “Clean-Room Technology Assessment Technique” (CTAT) was tested prospectively in the GMP facility of BCRT, Berlin, Germany, then retrospectively in the GMP facility of the University of California-Davis, California, USA. CTAT is a two-level model: level one identifies operational (core) processes and measures their fixed costs; level two identifies production (supporting) processes and measures their variable costs. The model comprises several tools to measure and optimize performance of these processes. Manufacturing costs were itemized using adjusted micro-costing system.ResultsCTAT identified GMP activities with strong correlation to the manufacturing process of cell-based products. Building best practice standards allowed for performance improvement and elimination of human errors. The model also demonstrated the unidirectional dependencies that may exist among the core GMP activities. When compared to traditional business models, the CTAT assessment resulted in a more accurate allocation of annual expenses. The estimated expenses were used to set a fee structure for both GMP facilities. A mathematical equation was also developed to provide the final product cost.ConclusionsCTAT can be a useful tool in estimating accurate costs for the ATMPs manufactured in an optimized GMP process. These estimates are useful when analyzing the cost-effectiveness of these novel interventions. |
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