Your Products Our Service Our Quality About Us Downloads GMP Cell + Virus Bank Characterization Safety testing for GMP cell and virus banks The safety testing of cell or virus banks at the level of the Master, Working and End of Production Cell Bank is a key element for cell- or virus-derived biopharmaceutical products. Characterization tests aim to confirm identity, genetic stability and purity of the cell or virus bank. The battery of tests to apply is often adapted depending on the type of cell line or virus seed under development. Virus banks might require neutralization procedure prior to testing. ViruSure’s experts are happy to give best advice on the testing requirements requested by regulatory authorities What our Clients Say Polina Kaidun , Head of the cell banking group, BIOCAD (Russia) European quality, professional approach and efficiency are the main advantages of ViruSure, with which we have been cooperating for several years. The employees are always very helpful and kind, give quick answers to inquiries and are ready for constructive dialogue in disputable situations. We wish the company sustainable development and prosperity. Recommended Assays for Characterization of Recombinant Cell Banks The majority of the tests are done at the Master Cell Bank (MCB) and End of Production Cell Bank (EPCB) level. Working Cell Bank (WCB) will be done with a reduced testing package. Identity Assay MCB WCB EPCB Identity Testing via QPCR – Cytochrome C Oxidase Gene Amplification • • • Purity Assays MCB WCB EPCB Microbial Contaminants Sterility according to EP/USP/JP • • • Mycoplasma according to EP/JP • • • Mycoplasma according to FDA PTC • • • Adventitious Viruses – General Virus Screening 28-day in vitro assay for the presence of viral contamination using 3 cell lines • (•) • In vivo assay for adventitious agents in suckling and adult mice, embryonated eggs • (•) Retrovirus Tests MCB WCB EPCB Transmission electron microscopy (TEM) • • Retrovirus infectivity test; extended XC plaque assay and extended S+L- focus assay • • Reverse transcriptase assay using the PERT assay (FPERT) • • Other Viruses – Specific Virus Tests MCB WCB EPCB Mouse antibody production test (MAP, only applicable to rodent cell lines) • Hamster antibody production test (HAP, only applicable to rodent cell lines) • Bovine viruses * • Porcine viruses * • Human viruses (recommended for human-produced cells) * • (•) Simian viruses * • Avian viruses * • Insect viruses * • * Testing requirement will depend on the species of the seed cells, on their history and to which raw materials they have been exposed. Let's Talk About Your GMP Cell + Virus Bank Characterization Tell us about your inquiry and we'll be in touch. NAME*: PHONE NUMBER: E-MAIL*: COMPANY: COUNTRY: MESSAGE: © ViruSure GmbH. All Rights Reserved. Downloads Imprint / Privacy Policy Contact Us Donau-City-Straße 1, A-1220 Vienna, Austria