NHS Advanced Therapies Unit

NHS Blood and Transplant



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.

Manufacturing Capability

The NHSBT Speke facility has two grade B rooms dedicated to the manufacture of cell therapies. There is also an additional grade B room and a grade C room shared with the NHSBT Tissue Services department. The department also has liquid nitrogen storage facilities and a dedicated QC laboratory.

Processing equipment:

  • Class II cabinets
  • CO2 incubators
  • Quantum Cell Expansion Systems
  • Sterile connecting devices
  • Controlled rate freezers
  • Liquid nitrogen storage vessels
  • Centrifuges
  • Orbital shaker
  • 4°C storage pharmacy fridges
  • Peristaltic pump
  • Filter integrity tester
  • Endosafe PTS
  • Cytospin
  • Line sealers
  • Sepax 2
  • Microscopes
  • Filter integrity tester
  • Endosafe PTS

Analytical equipment:

  • Haematology analyser
  • Flow cytometer

Process Capability

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


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 Specials  MS 25224
HTA 11018


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


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


Jon Smythe
email: Jon.smythe@nhsbt.nhs.uk
Tel: 07764280838

Location & Website

The facilities on this site took part in a survey in 2011 and have subsequently confirmed their license status.

If you are the manager of a facility licensed for ATMP manufacture in the UK, not included on this site and would like it to be please email angela@atmpmanufacture.org