Overview

Our team improves patient access to innovative treatments, through providing expert services in processing, storage and manufacturing cell, gene, and tissue products on behalf of the NHS, research institutions and industry. We are recognised nationally and internationally as a leading centre for the implementation and delivery of advanced therapies.

Part of the Newcastle Hospitals pharmacy directorate, we work in partnership with Newcastle University to support ‘bench to bedside’ translational research and clinical delivery of cell, gene, and tissue therapies to treat a wide range of patients.

Working to high standards of governance, regulation and operational efficiency, our focus is on maximising patient safety and product quality to enhance the lives of patients in Newcastle and further afield.

Our qualified scientists, quality assurance experts and production specialists have a track record of working with clients and partners across the full advanced therapy development process from early research to production of licensed medicines.

We operate a fully accredited (JACIE) and licensed (MHRA and HTA) GMP cleanroom facility across two sites at the Royal Victoria Infirmary (cell, gene and tissue laboratory) and the International Centre for Life (GMP manufacturing facility).

Our well-established haematology transplant service works in close collaboration with clinical teams and expertise to deliver clinical trials for advance therapy medicinal products (ATMP) in partnership with Newcastle University.

Manufacturing Capability

Our facilities are situated across two sites – one co-located within Newcastle’s Royal Victoria Infirmary – and between them house 11 cleanroom suites, with both positive and negative pressure environments.

All our cleanrooms operate to Grade C and Grade B backgrounds, with access to Isolator and Grade A microbiological safety cabinets.

Both facilities conform to the highest standards of GMP with full quality management and project delivery oversight, with:

• Closed system cell processing devices
• Modern vapour phase liquid nitrogen storage
• Controlled rate freezing facilities
• Cell culture and quality control laboratory capabilities.

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
• Complex Manufacturing

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
JACIE accreditation

Team

Director: Mark Jarvis
Operations: Kay Carruthers
Production: Nicholas Moyse, Emma Matthews
Quality: Dawn Hiles, Dean Bradley
Clinical Trials: John Davidge

Address

GMP manufacturing facility,
International Centre for Life,
West Wing,
Times Square,
Newcastle upon Tyne,
NE1 4EP,
UK

&

Cell, gene and tissue laboratory
Royal Victoria Infirmary,
William Leech building,
Medical School,
Newcastle upon Tyne,
NE2 4HH

Contact

GMPManufacturing@newcastle.ac.uk
Twitter. @ATMPNewcastle