Overview

The NHSBT Clinical Biotechnology Centre has four grade D rooms and three grade C rooms. One grade C room is dedicated to the aseptic filling of products in a pharmaceutical grade positive pressure isolator with a state of the art closed-vial sterile filling station. Class II MBSC or laminar flow cabinets are present in the other rooms dedicated to the manufacture of gene therapy and biotechnology products.

The CBC site has a MHRA licence for the manufacture and importation of molecular IMPs.

Manufacturing Capability

Processing equipment:

• HVAC System
• Class II cabinets / laminar flow hoods
• Pharmaceutical grade positive pressure isolator with BioQuell Clarus L-3 VHP generator capabilities
• Fermentation systems
• AKTA chromatography equipment
• Highly purified water plant
• Incubators and shaker incubators
• Freezers, fridges and storage areas including liquid nitrogen storage vessel
• Centrifuges
• Peristaltic pumps
• GMP grade Autoclave
• Laboratory grade dishwasher
• Emulsiflex high pressure homogeniser
• Aseptic Technologies Crystal M1 closed-vial sterile filling station for dispensing of products

Analytical equipment:

• UV / Visible spectrophotometer
• Filter integrity tester
• Endosafe PTS
• Microplate plate reader with fluorescence capability
• Osmometer
• pH & Conductivity meter
• Turbidity meter
• PCR equipment
• HPLC
• Electrophoresis equipment
• Gel analysis and documentation system
• Access to DNA capillary sequencer
• Environmental testing equipment

The CBC can process two products in parallel with a capacity
of up to 15 to 20 products per year, depending upon scale.

Process Capability

• manufacture of plasmid DNA for phase I/II clinical trials
• manufacture of recombinant proteins
• importation of recombinant proteins and gene therapy vectors as Investigational Medicinal Products into the EU
• process development
• fermentation
• purification
• consultation and advice on manufacture and quality control

Experience

The CBC has experience in the manufacture of plasmid DNA vectors as direct vaccines or for use in viral vector manufacture, production of recombinant proteins, production of monoclonal antibodies and the conjugation of antibodies for therapy.

To date the facility has manufactured over 50 plasmid DNA vectors, five recombinant proteins and been involved in over 14 clinical trials since 2001 (with over 400 patients treated). The CBC has developed an expertise in the manufacturing and testing of patient-specific DNA vaccines to current regulatory requirements.

Licenses Held

MHRA MIA IMP 25224
MHRA Specials
HTA 22518

Team

Production: Dr Paul Lloyd-Evans
Production Supervisor: Denise Phillips
Quality: Fred Goddard
QP: Keith Smith and Karen Burks

Address

University of Bristol,
Churchill Building,
Lower Langford,
Bristol,
BS40 5DU

Tel: 01179 289388

Contact

Paul Lloyd-Evans PhD, Operations Manager
paul.lloyd-evans@nhsbt.nhs.uk