Ratcliffe_RM+Submission_Revised+version+3+6_with+Figs.pdf (666.69 kB)
Qualification of academic facilities for small-scale automated manufacture of autologous cell-based products
journal contributionposted on 2017-08-08, 13:22 authored by Paul Hourd, Amit Chandra, David Alvey, Patrick J. Ginty, Mark McCall, Elizabeth RatcliffeElizabeth Ratcliffe, Erin Rayment, David Williams
Academic centres, hospitals and small companies, as typical development settings for UK regenerative medicine assets, are significant contributors to the development of autologous cell-based therapies. Often lacking the appropriate funding, quality assurance heritage or specialist regulatory expertise, qualifying aseptic cell processing facilities for Good Manufacturing Practice (GMP) compliance is a significant challenge. The qualification of a new Cell Therapy Manufacturing Facility (CTMF) with automated processing capability, the first of its kind in a UK academic setting, provides a unique demonstrator for the qualification of small-scale, automated facilities for GMP compliant manufacture of autologous cell-based products in these settings. This paper shares our experiences in qualifying the CTMF, focussing on our approach to streamlining the qualification effort, the challenges, project delays and inefficiencies we encountered and the subsequent lessons learned.
Funding and support of the EPSRC is acknowledged. Initial funding was secured from its Innovative Manufacturing and the Life Sciences Interface Programmes both for the remedi Grand Challenge and its successor; the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine. The construction of the CTMF was funded by Loughborough University and the former East Midlands Development Agency (emda). Support for the validation of the CTMF was provided by the Technology Strategy Board (TSB) and the Knowledge Transfer Account (KTA) of Loughborough University, funded by EPSRC.
- Mechanical, Electrical and Manufacturing Engineering
Published inRegenerative Medicine
Pages799 - 815
CitationHOURD, P.C. ...et al., 2014. Qualification of academic facilities for small-scale automated manufacture of autologous cell-based products. Regenerative Medicine, 9(6), pp. 799-815.
Publisher© Future Medicine
- AM (Accepted Manuscript)
Publisher statementThis work is made available according to the conditions of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) licence. Full details of this licence are available at: https://creativecommons.org/licenses/by-nc-nd/4.0/
NotesThis paper was accepted for publication in the journal Regenerative Medicine and the definitive published version is available at http://dx.doi.org/10.2217/rme.14.47