Cell Culture Company has performed a leachable/extractable study on the AutovaxID bioreactor system. The results showed that all levels of extractables and leachables were acceptable for the process supporting a Phase III human therapeutic drug. As with other single-use bioreactor systems, each process requires testing as different media, cells and culture conditions (temperature, pH, lactic acid level, time) will have an impact on the Leachables & Extractables levels.