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
Our Customers Say…
From the preliminary conclusion of this work, we are already pleased to thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor…
Project Manager, Belgium
Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects.
Program Manager, California
It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences™’ services to colleagues and friends.
Senior Scientist, Singapore
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!
