Cellular Therapies Facility

Newcastle University

AMC_C_FL_NewUni
AMC_C_FI_NewcastleUni

Overview

The Newcastle Cellular Therapies Facility is an MHRA-licensed clean room complex designed specifically for the production of cellular therapies. It is one of the biggest such facilities in Europe, making Newcastle the ideal place to manufacture cellular therapies for translational clinical research.

Newcastle University in conjunction with Newcastle upon Tyne Hospitals NHS Foundation Trust is a recognised UK centre for translational research, with substantial experience of cellular manufacture and setting up and delivering cell therapy clinical trials.

Manufacturing Capability

  • Up to nine Grade B (ISO BS EN 14644 Grade 5) rooms
  • Seven Class II microbiological safety cabinets providing GMP Grade A environments (ISO grade 5)
  • Miltenyi Biotec CliniMacs Plus
  • Miltenyi Biotec Prodigy
  • Two Grade C (Class 10,000, ISO grade 7) preparation rooms – (120 and 200 sq.ft.)
    with air-controlled pass through hatches to Grade B (Class 100, ISO grade 5) corridor
  • Temperature-controlled storage with dedicated cryogenic
    storage room
  • Write-up office
  • In-process Quality Control Laboratory
  • Controlled storage facilities with both quarantine
    and release capacity.
  • Access to University Core Facilities, including Flow Cytometry

Process Capability

  • Adherent cells
  • Suspension cells
  • T cells
  • Tissue processing
  • Gene modified cells (One grade B room only at RVI site)
  • Patient specific processes
  • Bulk allogeneic processes

Experience

We are experienced in ATIMP manufacture for non-commercial and commercially sponsored trials,
and have a track record in:

  • Somatic cell therapies
  • Haematopoietic stem cell therapies
  • Manufacture from an embryonic stem cell line
  • Cryopreservation

 

We are also experienced in preparing ATIMPs for patient administration, facilitating and providing oversight for commercial ATIMP trials for the Newcastle upon Tyne Hospitals NHS Foundation Trust.

The Facility also works with leading clinicians to develop and manufacture novel cellular therapies:

  • Autologous tolerogenic dendritic cells for rheumatoid arthritis (AuToDeCRA)
  • Mesenchymal stem cells for Graft versus Host Disease
  • Mesenchymal stem cells for autoimmune disease •Mesenchymal stem cells and chondrocytes for osteoarthritis
  • Limbal stem cells for limbal stem cell deficiency
  • Autologous islet transplantation
  • Allogeneic islet transplantation

Licenses Held

MHRA MIA IMP 17136
MHRA Specials 17136
HTA 11122

Team

Director: Prof Anne Dickinson
Production:
Dawn Plant, Emily Swinburne,
Emma Matthews
Quality: Dean Bradley, Dr Julian de Havilland
QP: Anne Black

Address

Cellular Therapies Facility,
Biomedicine West Wing,
International Centre for Life,
Times Square,
Newcastle upon Tyne,
NE1 4EP,
UK

&

Cellular Therapies Facility,
Haematological Sciences,
Newcastle University,
Framlington Place,
Newcastle upon Tyne,
NE2 4HH,
UK

Contact

celltherapy@ncl.ac.uk
Twitter. @CellTherapyNewc

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

Contact Us

If you have an inquiry send us your name, email and message.

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