Virus Bank Characterization
The virus bank, also known as virus seed or virus stock, is an important component for producing virus-related biological products, such as vaccines, recombinant proteins, and gene therapy products. The establishment of a virus bank can ensure the reproducible production and testing of recombinant viruses. In the manufacturing process, virus bank can be divided into master virus seed stock (MVSS) and working virus seed stock (WVSS). An MVSS is prepared from virus-infected mammalian cell lines or insect cell lines. It must be tested to demonstrate that the viruses are free of contamination and are replication-competent with high viral titer. Once a successful MVSS is established, all production must use viruses that are direct passages from the MVSS. The direct passage of MVSS is called a WVSS from which the viral titer is expanded for biological products. The WVSS should also be tested to demonstrate to be free of adventitious agents from the species or manufacturing environment.
Virus Bank Characterization at Creative Animodel
Characterization of virus banks requires technical expertise across a broad range of biological disciplines. Understanding the requirement and subsequent development of the characterization is also important to ensure the acceptance by the worldwide regulatory agencies. Creative Animodel has rich experience in virus bank characterization in both technical and regulatory aspects. We have established all necessary technology platforms, assays, and quality oversight systems to conduct these critical testing programs.
Creative Animodel provides comprehensive virus bank characterization services, including virus identify, virus activity tests, and adventitious agent tests. The most highly customized element among them is the detection of adventitious viruses. The necessity and specifications for each of these characterizations are assessed on a case-by-case basis and can be changed depending on the phase of product development and the feedback from the numerous sources.
|Genetic characterizationPCR / Next Generation Sequencing (NGS)|
|Replication-competent virus testVirus titer measurement|
|Sterility testMycoplasma detectionGeneral virus screensAdventitious virus test|
AdvantagesVarious cell lines of human and animal origin as indicator cellsA wide range of human and animal viruses available as positive controlsDifferent PCR assays developed for detection of specific adventitious or contaminating virusesComplete assay panels performed for hundreds of virus banksCustom assays developed for unique viruses as needed
As virus bank characterization is a case-by-case program, experts at Creative Animodel will consult with you to determine the experimental scheme that can meet the regulatory requirements. If you have any needs, please don’t hesitate to contact us.