Phase I / II Clinical Lot Manufacturing
For Phase I/II Clinical Lot Manufacturing, we offer:
Viral Vector Manufacturing and Vaccine Manufacturing
The manufacturing facility in Glasgow, UK is licensed to manufacture a range of biological active substances under contract for clinical trials, in accordance with the European Union (EU) Clinical Trials Directive 2001/20/EC.
BioReliance's extensive experience with viral vectors results in a significant advantage in understanding the unique requirements of this field. In addition to capabilities for manufacturing gene therapy products, BioReliance also offers production of viral vaccine products.
Our experience includes:
- Production of clinical grade vaccines and gene therapy products for human and veterinary use, including the first gene therapy product
- Manufacturing of hundreds of cell banks and virus seed stocks from a broad range of viral vectors and viral vaccines for early phase clinical trials
- Production technologies such as cell factories, T-flasks, bioreactors, cell cubes and disposables
- Purification technologies which include depth and tangential flow filtration, sucrose, caesium chloride gradient ultracentrifugation and a range of chromatography systems
