Bio-safety testing programmes span the product cycle from early pre-clinical development through to licensed production. Application of quantitative polymerase chain reaction (Q-PCR) technology within this industry is now well established.
This PCR based fluorescence technology has significant advantages for gene expression studies, pathogen detection and viral clearance studies.
BioReliance has developed and validated the use of quantitative polymerase chain reaction (Q-PCR) assays for the detection and quantification of nucleic acid and retroviral reverse transcriptase (Q-PERT).
The increased sensitivity and reproducibility of this assay system allows quantitation of specific pathogens and contaminating host cell DNA in therapeutic products. Process validation studies for removal and/or inactivation of endogenous and adventitious viruses and DNA now combines the use of both infectivity assays and Q-PCR methods. Products that require clearance studies are those produced in mammalian cells, gene therapy, raw materials and products derived from human blood and plasma.
Regulatory agencies including FDA, CPMP and ICH consider total clearance on a case to case basis and the use of Q-PCR to examine virus removal is now standard practice. BioReliance supports product applications and decreases the time to regulatory submission through the use of state of the art technologies. u
ENQUIRY No 76
BioReliance is based in Stirling, UK. www.bioreliance.com
