Overview

The MHRA facility in Speke is part of a complex of 11 GMP grade clean rooms that offer flexible space for clinical work and GMP developments. There are also two routine laboratories for analytical testing, cryopreservation and long term storage. Apart from numerous Grade A laminar air flow cabinets the facility contains CO2 incubators, flow cytometers and controlled-rate freezers.

The facility is licensed for the procurement, testing, processing, preservation, storage and distribution of tissues and cells for patient treatment, research and starting materials for ATMP. Manufacture of blood-derived medicinal products under MS licence and manufacture of cell therapy medicinal products under the MIA (IMP) licence. Wholesale Dealing of POM, large and small volume steriles and handling/storage of unlicensed MP from EEA states.

Process Capability

• Adherent cells
• Suspension cells
• T cells
• Tissue processing
• Autologous cell processing
• Allogeneic cell processing

Experience

The ATU has experience of the genetic manipulation of T cells, cell selection and depletion protocols and broad cell culture knowledge. The unit also has experience of the isolation and culture of mesenchymal stromal cells from bone marrow and umbilical cord plus peripheral blood stem cells for clinical trials. The laboratory has prepared master and working cell banks under GMP.

Licenses Held

MHRA MIA IMP 25224
MHRA Specials  MS 25224
HTA 11018

Team

Production: Dr Eric Austin
Quality: Dave Harwood
QP: Keith Smith

Address

NHS Blood and Transplant,
14 Estuary Banks,
Estuary Commerce Park,
Speke,
Liverpool,
L24 8RB