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ATCC Vero Cells Used To Manufacture Second Rotavirus Vaccine For Clinical Trials

Posted on: Monday, 19 November 2007, 18:00 CST

ATCC (American Type Culture Collection) announced today that its master cell bank of highly characterized Vero cells will be used for the manufacture of a second promising rotavirus vaccine candidate.

The rotavirus vaccine candidate was developed by Murdoch Childrens Research Institute (MCRI) in Victoria, Australia. ATCC Vero cells will be used as substrates to grow the rotavirus strain that is being used in the vaccine.

Several features make ATCC's Vero master cell bank a desirable substrate for vaccine development and manufacture. The bank was started from Vero cells provided to ATCC in 1967, establishing a known pedigree and allowing full traceability. The deposit date is well before the FDA-established 1980 cut-off date for concern about the risk of bovine spongiform encephalopathy (mad cow disease) in materials used in vaccines. The cells were grown under current Good Manufacturing Practice (cGMP) conditions using fully traceable and documented culture reagents. At cell passage number 123, the bank ensures sufficient additional population doublings for manufacturing effective, high-titer vaccines.

"Since the ATCC Vero cells were developed and handled according to cGMPs, they offer an excellent mechanism to grow the virus and move the improved vaccine candidate through clinical trials," said Professor Ruth Bishop of the Enteric Virus Group at Murdoch Childrens, group leader for the development of the new vaccine.

The rotavirus vaccine, RV3, is developed from a strain of the virus that conferred 100% protection against severe rotavirus disease among children infected naturally. This and other qualities made the strain a good vaccine candidate. While initial tests with the vaccine were promising, the current effort with the ATCC Vero cells is aimed at producing a higher-titer vaccine in the hope that it will elicit a greater immune response in future trials.

"The pedigree of the ATCC Vero cells, as well as their lower passage number, make them excellent components in vaccine development projects," said Dr. Raymond Cypess, ATCC President and CEO. "We are proud to be involved with a study that could have such a profound positive impact on the health of the world's children."

Rotavirus infection is the leading cause of severe gastroenteritis in infants and young children worldwide. Annual deaths among children under five from rotavirus total close to 500,000, with most deaths occurring in resource-poor regions where the dehydration caused by the gastroenteritis combines with malnutrition to form a lethal pair.

The ATCC Vero cells are provided to Murdoch Childrens Research Institute as part of an agreement with the global health organization PATH. In February 2007, ATCC and PATH announced that ATCC's Vero cells were selected for the manufacture of a separate rotavirus vaccine developed by National Institute of Allergy and Infectious Diseases (NIAID) scientist Dr. Albert Kapikian and colleagues (www.atcc.org/common/pressRoom/announcements.cfm#vero).

For more information on this project, visit MCRI at www.mcri.edu.au or PATH at www.path.org.

About ATCC

ATCC is the world's largest biological resource center and the most comprehensive source of reference cultures and reagents used by researchers in academic and industry laboratories. Since 1925, ATCC has set the standard for authentication and distribution of biological reference materials for life science research in the public and private sector. www.atcc.org.

Source: Business Wire

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