Qualification of Academic Facilities for Small-Scale Automated Manufacture of Autologous Cell-Based Products

Abstract

Academic centers, 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 GMP compliance is a significant challenge. The qualification of a new Cell Therapy Manufacturing Facility 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 Cell Therapy Manufacturing Facility, focusing on our approach to streamlining the qualification effort, the challenges, project delays and inefficiencies we encountered, and the subsequent lessons learned.

Keywords::

• ATMP
• autologous
• automation
• cell therapy
• GMP
• manufacturing
• qualification
• regulation
• validation

Acknowledgements

The authors would like to acknowledge TAP Biosystems for providing technical and services support for the Compact Cellbase system.

Financial & competing interests disclosure

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 Center 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. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

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 Center 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. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.