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 E. coli bacterial cell lines for all stages of production under GLP/GMP regulatory compliance. Negative and positive controls will be plated along with the test articles.
| Prophage Test | Mytomycin C is used to induce the development of active phage from the prophage state, if present, of a E. coli bacterial cell bank. |
| Lytic Phage Test | This bacteriophage test service is offered to test the presence or absence of lytic phage contaminants in a E. coli bacterial cell bank as part of pre-banking tests. |
| Bacteriophage Titer | This test is offered to evaluate the concentration of phage contaminants in a E. coli bacterial cell bank. |
| Phage Identification | Next generation sequencing method is used for de novo construction of contaminating phage sequence, which is then blasted against NCBI database for highest match. |
CGMP/GLP Compliant
Genomics & Biological Services
- Experienced scientists functioning as project managers or study directors
- Independent quality unit assuring regulatory compliance
- Methods validated per ICH GLP/GMP guidelines – also research grade testing available
- Rigorous sample tracking and handling procedures to prevent mistakes and cross-contamination
- Controlled laboratory environment to prevent cross-contamination
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