Cell therapy-processing economics: small-scale microfactories as a stepping stone toward large-scale macrofactories

Richard P Harrison, Nicholas Medcalf, Qasim A. Rafiq

Research output: Contribution to journalArticlepeer-review

Abstract

Aim: Manufacturing methods for cell-based therapies differ markedly from those established for noncellular pharmaceuticals and biologics. Attempts to ‘shoehorn’ these into existing frameworks have yielded poor outcomes. Some excellent clinical results have been realized, yet emergence of a ‘blockbuster’ cell-based therapy has so far proved elusive. Materials & methods: The pressure to provide these innovative therapies, even at a smaller scale, remains. In this process, economics research paper, we utilize cell expansion research data combined with operational cost modeling in a case study to demonstrate the alternative ways in which a novel mesenchymal stem cell-based therapy could be provided at small scale. Results & Conclusions: This research outlines the feasibility of cell microfactories but highlighted that there is a strong pressure to automate processes and split the quality control cost-burden over larger production batches. The study explores one potential paradigm of cell-based therapy provisioning as a potential exemplar on which to base manufacturing strategy.
Original languageEnglish
Pages (from-to)159-173
JournalRegenerative medicine
Volume13
Issue number2
Early online date6 Mar 2018
DOIs
Publication statusE-pub ahead of print - 6 Mar 2018

Bibliographical note

Copyright: The Authors

This work is licensed under the Creative Commons Attribution 4.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/

Keywords

  • automation
  • bioprocessing
  • cell expansion
  • cell factories
  • cost of goods (COG)
  • manufacturing
  • process economics
  • stem cell therapy

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