Our Current Facilities
Our facilities occupy 400 m2 over two floors, with a production area including a preparation laboratory complete with environmentally-controlled storage areas and clean room suite occupying the ground floor. Offices, quality control and assay development laboratories are on the upper floor. The clean room suite comprises four grade D rooms for fermentation and buffer preparation, and two grade C rooms for downstream purification. We also have a dedicated grade C final fill and finish clean room.
We have dedicated microprocessor-controlled fermenters, providing a closed system for microbial derived products. Cell extraction and preparation of lysates by physical or chemical extraction is performed in a grade D environment.
Manual aseptic filling is performed within a dedicated Aseptic Technologies CrystalTM M1 closed vial filling station in a grade A environment provided by a pharmaceutical grade isolator.
The isolator is fitted with an integrated vapour phase hydrogen peroxide generator for routine bio-decontamination. It has two type D (B grade) transfer hatches for the movement of materials in and out.
Specialist Processing Equipment
- 15 L Electrolab glass fermenter vessels and control systems
- Avestin Emulsiflex high pressure homogeniser
- GE Healthcare AKTA chromatography equipment
- Tangential Crossflow Systems
- Aseptic Technologies Crystal M1 closed-vial sterile filling station for dispensing of products
- Pharmaceutical-grade positive pressure isolator with BioQuell Clarus L-3 VHP generator capabilities
- GMP-grade autoclave
- Highly purified water plant
Specialist Analytical Equipment
- ABI Capillary DNA sequencer
- Electrophoresis for DNA and protein analysis
- Charles River Endosafe PTS
- Environmental testing equipment
- Pall Filter integrity tester
- Gel analysis and documentation system
- Shimazdu iProminence HPLC Systems
- Real Time PCR
- Tecan Microplate reader with fluorescence capability
- Turbidity meter
- UV/visible spectrophotometers
Our new facility – arriving 2022
Building started for a new state of the art facility for CBC in January 2020. This will be co-located with our existing Cell Therapy Facility at the Filton Blood Centre (Bristol). From this new site, due to open in 2022, we will offer a ‘one-stop-shop’ service covering all areas of gene therapy development, from the manufacture of plasmids, viral vectors, gene editing to the transduction of patient and donor cells.
Our new extension will total 940m2 of space covering two floors, and will include:
- Suites of clean rooms designed for parallel manufacture of bacterial and mammalian cell-derived products
- Laboratories equipped to undertake pre-GMP manufacture, development and QC testing
- Capacity to manufacture 4 GMP-grade plasmids in parallel
- Flexibility to manufacture different product types
- A dedicated development laboratory
- Agile offices and break out areas