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news.Meridian Life Science, of Memphis, Tennessee, a wholly-owned subsidiary of Meridian Bioscience, is proud to announce they have been selected by the Centers for Disease Control and Prevention (CDC) to develop a process for manufacture of a rotavirus vaccine.
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Funding for this activity will be provided through a Small Business Innovation Research (SBIR) contract. Process development will focus on optimization of growth and yield of the virus in cell culture, developing and characterizing a column-based purification process followed by formulation, inactivation and filling of the vaccine.
This SBIR II, which follows an initial SBIR I awarded to MLS in 2013, will fund a 15 month research and development effort leading to scale up and manufacture of a rotavirus vaccine for use in clinical trials.
MLS is a contract manufacturer offering production of vaccines and challenge stocks which employ current Good Manufacturing Practices (cGMP) as described in 21 CFR Parts 210 and 211.
According to the CDC’s website, rotavirus causes gastroenteritis (inflammation of the stomach and intestines). The rotavirus disease causes severe watery diarrhea, often with vomiting, fever, and abdominal pain. In babies and young children, it can lead to dehydration (loss of body fluids).
Rotavirus is the leading cause of severe diarrhea in infants and young children worldwide. Globally, it causes more than a half a million deaths each year in children younger than 5 years of age.
Dr. Victor Van Cleave, Vice President of Research and Development (R&D) at Meridian Life Science said, "Meridian is pleased to have been selected by the CDC to receive this SBIR II award and appreciate the CDC’s continued confidence in our ability to deliver a novel process for rotavirus vaccine production. Rotavirus is a serious problem globally for infants and we feel honored to be a part of this program to assist in the eradication of this challenging health issue.
"The project is an excellent fit for Meridian’s core virology and virus-based product manufacturing capabilities. The earlier SBIR I award from the CDC set the stage for this latest stage of development and our scientists are proud to be a part of an effort that could significantly reduce the incidence and severity of rotavirus infections in children."