Researchers in Carnegie Mellon University's Department of Chemical Engineering are collaborating with leading biotechnology company Genentech, a member of the Roche Group, and LumaCyte, a biotechnology instrumentation company based in Charlottesville, Virginia, to develop an advanced biomanufacturing technology for adventitious agent testing, or testing for unexpected viral infections during the production of biopharmaceuticals.
The research received funding from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a Manufacturing USA institute, to develop and test technologies for improving the safety testing of biologic medicines during production and prior to release. This project, which aims to rapidly and accurately detect viral infectivity in biopharmaceuticals, was one of the first four proposals funded by NIIMBL. The team, which includes Carnegie Mellon, Genentech and LumaCyte, will receive $1.5 million in funding from NIIMBL over 18 months.
When using biological materials such as mammalian cell lines to produce pharmaceuticals, manufacturers face the risk of viruses infecting the batch. Currently, testing for adventitious agents such as viruses happens late in the manufacturing process - but the research team, which includes Chemical Engineering Professor Jim Schneider and Adjunct Professor Todd Przybycien, are developing technologies to test biopharmaceutical batches while they are being produced.
"If you don't find out about infection until very late in the process, you will have wasted a lot of time and money as more downstream equipment and product becomes infected," Schneider said. "Current infection detection techniques, such as cell-based assays and polymerase chain reaction, can take days to complete. Our methods can provide readout in less than 15 minutes, which enables a routine, continuous type of testing that could detect infections almost as soon as they take hold."