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|Title: ||Qualification of academic facilities for small-scale automated manufacture of autologous cell-based products|
|Authors: ||Hourd, Paul C.|
Ginty, Patrick J.
McCall, Mark J.S.
Williams, David J.
|Issue Date: ||2014|
|Publisher: ||© Future Medicine|
|Citation: ||HOURD, 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.|
|Abstract: ||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.|
|Description: ||This 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|
|Sponsor: ||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.|
|Version: ||Accepted for publication|
|Publisher Link: ||http://dx.doi.org/10.2217/rme.14.47|
|Appears in Collections:||Published Articles (Chemical Engineering)|
Published Articles (Mechanical, Electrical and Manufacturing Engineering)
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