Phage contamination of bacterial cultures is a common complication for the biotech and pharmaceutical industries. The presence of phage in cultures can bias results by interfering with bacterial identification and isolation. Phage are not susceptible to antibiotic treatments and therefore difficult to remove from infected cultures of bacteria. Being ubiquitous and abundant, phage can become a serious problem for companies using microbial cell lines to produce recombinant products.
Regulatory agencies require companies using microbial cell lines that produce products for human use to regularly complete biosafety testing to ensure that cell banks are free of phage contamination. (US FDA (21 CFR Part 58 and 210/211) Both master cell banks (MCB), and end of production cell banks (EOP) must be tested regularly for phage contamination. The testing frequency varies between products and is regulated on a case by case basis by the applicable regulatory agency.
Avance Biosciences offers comprehensive services for bacterial cell lines for all stages of production under cGMP/GLP regulatory compliance. Negative and positive controls will be plated along with the test articles.
Genomics & Biological Services
Phage Testing Services
All Avance Services Include
Experienced scientists functioning as project managers or study directors
Controlled laboratory environment to prevent cross-contamination
Rigorous sample tracking and handling procedures to prevent mistakes and cross-contamination
Methods validated per ICH GLP/GMP guidelines – also research grade testing available
Projects customized and tailored to suit your needs
Independent quality unit assuring regulatory compliance
Transparent process flow and weekly report on project progress
Professional project reports ready for regulatory filing
Fast turn-around time & Competitive pricing