Cellular Therapies Facility
The Newcastle Biomedicine Cellular Therapies Facility (NBCTF)
is a state-of-the-art clean room GMP service providing a
dedicated home for the development of Advanced Therapeutic
Medicinal Products (ATMPs), regenerative medicine therapies
for use in clinical trials, tissue preparation for transplant and for
the development of human Embryonic Stem Cells (hESCs).
Services Offered
The facility works to a Pharmaceutical Quality
Management System (PQMS) designed to meet the
requirements of the UK’s primary competent bodies.
These are the Human Fertilisation and Embryology
Authority (HFEA), Human Tissue Authority (HTA– this license is required in the UK in order to be able
to handle, store and minimally manipulate cells and
human tissues) and Medicines and Healthcare
Products Regulatory Agency (MHRA).
The facility is joined up with the Stem cell laboratory in Haematological Sciences, Institute of Cellular Medicine, to form the joint (NBCTF). This facility has over 15 years experience of working with haematopoeitic stem cells, including Miltenyi Clinimacs isolation and T-cell depletion techniques. Professor Anne Dickinson is the director of the facility and brings with her over 25 years of experience in the manipulation of haematopoietic stem cells for clinical use.
The facility consists of 9 EU GMP ‘Grade B’ clean rooms, supported by 2 ‘Grade C’ preparation rooms, making the provision one of the largest academic run units in Europe. ‘Grade A’ working environments are provided for all cell manipulation activities; together with comprehensive incubation, centrifugation and storage facilities.
A Qualified Person (QP) is also available to ensure standards are met. The clean area and associated incubators and storage facilities are monitored 24 hours a day, 7 days a week. This means that every client can be confident that all work carried out in the facility is performed to the highest of standards and to the requirements of current regulatory authorities.
Further information:
- Contact: Dr. Julian De Havilland, Facility Manager
- E-mail: julian.de-havilland@ncl.ac.uk
- Telephone: +44 (0)191 241 8814
- Contact: Professor Anne Dickinson, Director
- E-mail: a.m.dickinson@ncl.ac.uk
- Telephone: +44 (0)191 222 6794
- Website: www.ncl.ac.uk/ctf