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.
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.
This test is offered to evaluate the concentration of phage contaminants in a E. coli bacterial cell bank.
Next generation sequencing method is used for de novo construction of contaminating phage sequence, which is then blasted against NCBI database for highest match.
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
We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a note or give us a call to find out what Avance can do for you.
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When you partner with Avance Biosciences™, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!
Dedication to Quality
The Avance Biosciences™ team is committed to strict adherence to CGMP and GLP regulations enacted by the US, European, Japanese, and other international regulatory agencies.
Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.
Transparency and integrity are two of our core values. Our well-trained, friendly, and professional study directors and project managers strive to complete your projects on-time with open communication channels and to your specifications.
Avance Biosciences™’ CGMP/GLP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, ddPCR, Sanger sequencing, next-gen sequencing, Southern blot, and more.