GangaGen, with expertise in phage biology offers customized bacteriophage testing services to determine the presence or absence of phage contaminants in E. coli cell banks or production cells. Our team has about twenty years of experience and provides high quality phage testing services in tune with regulatory requirements in a timely manner. We offer both lytic and lysogenic phage detection for E. coli cell banks.
The commercial production of recombinant biologicals and therapeutics is an important outcome of modern biotechnology. Selecting an ideal host bacterium to produce specific protein of interest is an important step in developing a production process. Widespread use of E. coli and other bacterial systems in biotechnology has led to the development of many different strains/cell lines. The process developed in production of therapeutics has to be taken to industrial scale to get viable industrial production mainly through fermentation technology.
The starting material for manufacturing includes a well characterized bacterial culture, known to be free from bacteriophage and is capable of expressing the protein product of interest in good measure. Production host bacterial cell “seed lot” system is used by manufacturers to assure identity and purity of the starting raw material viz., production host culture. A cell seed lot/research cell bank consists of aliquots of a single culture from where the “Master Cell Bank” (MCB) and “Working Cell Bank” (WCB) are derived. A well-characterized cell bank assures lot-to-lot consistency of the product. Regulatory agencies such as USFDA, EMEA require MCBs to adhere to ICH guidelines which emphasizes on characterization and testing to establish identity, purity and genetic stability of the cell line. A phage contaminated cell bank cannot be termed as "stable" as it may not generate the required cell density in a sustainable fashion during the fermentation process because of contaminating phages. Thus, it becomes essential to establish absence of phages in cell banks by conducting the prescribed battery of tests.
We offer both lytic and lysogenic phage detection for E. coli cell banks. This service offered by GangaGen is an ISO-9001:2015 certified activity.