Loughborough University
Leicestershire, UK
LE11 3TU
+44 (0)1509 263171
Loughborough University

Centre for Biological Engineering

The Establishment and Validation of a Regulated Good Manufacturing Practice (GMP) Facility for Knowledge Transfer in Cell Therapy Manufacturing and Process Development

CompacT SelecT

The clinical and product opportunities for cell therapeutics have become clear, with products entering the translational pipeline from the science base to business. Business begins with a primary focus on successfully reaching ‘first in man’ clinical targets; this is followed by the ‘one-to-many’ translation process – the rapid expansion of delivery capability. One of the major challenges in developing therapies using cells is to translate the cell culture from laboratory scale into clinically effective, reproducible and economically acceptable manufacturing processes.

Loughborough University with the support of the EPSRC, the East Midlands Development Agency (emda) and the Technology Strategy Board (TSB) has funded the design, construction and commissioning of the Cell Therapy Manufacturing Facility (CTMF) located at the Centre for Biological Engineering (CBE) at Loughborough University. The CTMF, designed to run to a EU GMP Classification Grade B standard (as defined in EurdaLex Vol 4, Annex 1), includes separate areas for both manual and automated cell culture, the latter containing an automated GMP-specified cell culture platform (CompacT Cellbase; ‘The Automation Partnership’) incorporating a EU Classification Grade A processing environment.

The facility has been validated to an operational qualification level along with the automated cell culture platform. Discussions are ongoing in preparation for Medicines and Healthcare products Regulatory Agency (MHRA) inspection and licensing for the manufacture of cell based therapeutics for clinical use based on the business case. The facility will provide both the physical requirements and technical expertise to aseptically culture, expand, differentiate and harvest human adherent cells. With the establishment of a viable business case, the ultimate aim is to deliver contract research services (including process design (QbD), development, transfer and improvement) and manufacturing services for the preparation of GMP compliant batches of cell-based therapeutics for clinical trials.

The facility is being used to understand the detail of the automation of cell processing by tackling scientific bottleneck exemplars including the effect of carryover of enzymatic digestion agents during cell detachment, the development of reference cell standards for process development, and understanding the issues arising from transfer of therapeutic grade cells to the GMP automation platform and the scale-up of a clinically led gene therapy cell line.

Funding bodies

Project dates / duration

2010 - 2014 and beyond

Project team

Validation Steering Committee:

Extended Project Team:

Collaborators

Contact

Prof David Williams: D.J.Williams@lboro.ac.uk, 01509 227668

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State-of-the-art facility

The facility is made up of a suite of Class 2 laboratories for cell growth, a bioelectrical facility and an analytical suite to service all laboratories.

Find out more about the Centre's facilities »