ATCC(R) Vero Cells Supplied For Rotavirus Vaccine Commercialization.

MANASSAS, Va. -- ATCC (American Type Culture Collection) today announced a licensing agreement with the global health nonprofit organization PATH to provide a master cell bank of highly characterized ATCC Vero cells for use in developing and manufacturing a new type of rotavirus vaccine.

Master banks of Vero cells are used in vaccine manufacturing to grow viruses specially designed to elicit an immune response to infectious agents such as rotavirus.

Rotavirus is the most common cause of severe gastroenteritis in infants worldwide, causing half a million deaths and more than 2 million hospitalizations a year in children under 5 years of age. Children in the poorest countries consistently account for more than 90 percent of rotavirus deaths. Because access to medical care is limited in developing countries, the most effective strategy to reduce the toll of rotavirus disease is prevention through vaccination.

A UK Bovine Human Reassortant vaccine developed by National Institute of Allergy and Infectious Diseases (NIAID) scientist Dr. Albert Kapikian and colleagues specifically targets rotavirus strains common in lower-income countries. NIH has recently licensed the virus strains for this vaccine to eight manufacturers for vaccine development and introduction. PATH is providing technical support to the manufacturers in order to help accelerate development of safe, effective, and affordable vaccines for the developing world. The ATCC Vero cells will be a key component in the production of a rotavirus 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 1966, 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.

"ATCC is proud to contribute to this global health effort," ATCC President and CEO Dr. Raymond Cypess remarked. "As part of ATCC's commitment to translational research by extending the use of its cultures to clinical applications, we will work to provide Vero cells to the wider vaccine development community for future vaccine projects."

"The ATCC Vero master cell bank is an invaluable resource for vaccine production," said Rajat Goyal, project director for PATH's Advancing Rotavirus Vaccine Development Project. "ATCC's involvement in PATH's rotavirus program will help address a pressing global health issue in the places where it hits hardest."

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, also known as American Type Culture Collection, 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.