Cell substrates are used in various stages of viral vaccine manufacturing, as in the isolation, selection, and propagation of the virus seed or virus vector stock, as well as for the amplification of the virus to produce the final vaccine product. The various stages of cell substrate use, including cell banking, are shown in a generic manufacturing scheme in Figure 1. Traditionally, viral vaccines have been produced in animal tissues, primary cell cultures, and cell lines that either have a finite life span, such as normal diploid cells, or a theoretically infinite life span, as achieved with continuous or immortalized neoplastic cells. The cell substrates used in viral vaccines currently licensed in the US are listed in Table 1…
Tag: <span>viral vaccines</span>
The Vero cell line is one of the most widely used continuous cell lines in the world, cited in over 10,000 publications. Though originally developed as a host for viral replication, uses for this highly adaptable cell line have expanded far beyond the research laboratory to include diagnostic practices in hospitals, epidemiological surveys, in vitro fertilization clinics, bacterial toxin assays, and vaccine production. ATCC has played a pivotal role in this expansion by distributing the Vero cell line, ATCC® CCL-81™, to the worldwide scientific research community. Recently, ATCC developed a fully-characterized master cell bank of Vero cells prepared under current good manufacturing practice (cGMP) conditions (ATCC® CCL-81.4™). This report traces the history of the Vero cell line from its origins in the laboratory of Dr. Yosihiro Yasumura to its use as a continuous cell substrate for vaccine manufacturing…
This paper reviews the manufacturing of veterinary viral vaccines and discusses the industry regulatory frameworks in both the European Union and the United States, the world’s two largest regulatory markets. We also address specific technical and regulatory issues associated with viral vaccine inactivation. Finally, we present two case histories for conventional viral vaccines: Foot and Mouth Disease Virus (FMDV) and Marek’s Disease, which are both long-established conventional vaccines, but nevertheless of great interest…