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Benchmarking biopharmaceutical process development and manufacturing cost contributions to R&D

Farid, SS; Baron, M; Stamatis, C; Nie, W; Coffman, J; (2020) Benchmarking biopharmaceutical process development and manufacturing cost contributions to R&D. mAbs , 12 (1) , Article 1754999. 10.1080/19420862.2020.1754999. Green open access

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Abstract

This study aims to benchmark and analyze the process development and manufacturing costs across the biopharmaceutical drug development cycle and their contribution to overall research and development (R&D) costs. This was achieved with a biopharmaceutical drug development lifecycle cost model that captured the costs, durations, risks and interdependencies of the clinical, process development and manufacturing activities. The budgets needed for process development and manufacturing at each phase of development to ensure a market success each year were estimated. The impact of different clinical success rate profiles on the process development and manufacturing costs at each stage was investigated, with a particular focus on monoclonal antibodies. To ensure a market success each year with an overall clinical success rate (Phase I to approval) of ~12%, the model predicted that a biopharmaceutical company needs to allocate process development and manufacturing budgets in the order of ~$60 M for pre-clinical to Phase II material preparation and ~$70 M for Phase III to regulatory review material preparation. For lower overall clinical success rates of ~4%, which are more indicative of diseases such as Alzheimer’s, these values increase to ~$190 M for early-phase and ~$140 Mfor late-phase material preparation; hence, the costs increase 2.5 fold. The costs for process development and manufacturing per market success were predicted to represent 13–17% of the R&D budget from pre-clinical trials to approval. The results of this quantitative structured cost study can be used to aid decision-making during portfolio management and budget planning procedures in biopharmaceutical development.

Type: Article
Title: Benchmarking biopharmaceutical process development and manufacturing cost contributions to R&D
Open access status: An open access version is available from UCL Discovery
DOI: 10.1080/19420862.2020.1754999
Publisher version: https://doi.org/10.1080/19420862.2020.1754999
Language: English
Additional information: © 2020 The Author(s). Published with license by Taylor & Francis Group, LLC. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/).
Keywords: Process development, manufacturing costs, biopharmaceutical, drug development cycle, chemistry, manufacturing and controls, clinical success rates, phase transition rates
UCL classification: UCL
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering
URI: https://discovery.ucl.ac.uk/id/eprint/10098585
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