Meridian Life Science, Inc., (MLS) of Memphis, Tennessee, a wholly-owned subsidiary of Meridian Bioscience, Inc. (NASDAQ:VIVO), recently completed the manufacture of a human rhinovirus Type 16 challenge stock. MLS manufactured the rhinovirus challenge stock under contract and according to the appropriate current Good Manufacturing Procedures (cGMPs) for use in early-phase human clinical trials while simultaneously meeting the desired titer specifications under aggressive timelines.
Challenge stocks are wild type, native viruses that are fully capable of causing disease in the target population. These virus preparations are designed to be used in conjunction with clinical trials testing the efficacy of a given therapeutic. A challenge stock of infectious virus permits infection of a group of healthy volunteers where the precise viral dose, timing and progression of disease can be monitored. In turn, administration of the anti-viral therapeutic or vaccine may be tested at varying times and doses to better understand the efficacy of the drug in a controlled environment. Beyond the advantages of providing a carefully monitored test environment, the use of a challenge stock in designing an efficacy study is the increased efficiency in patient enrollment, and time to completion of the study. In clinical efficacy trials that depend on the identification of randomly infected individuals for inclusion in the study, it is common to encounter long delays and difficulties with identification of appropriate test subjects. Studies utilizing challenge stocks such as the human rhinovirus permit rapid enrollment and testing of the therapeutic resulting in significant cost savings along the road to commercialization.
Victor Van Cleave, Ph.D., Vice President of Research and Development (R&D) at Meridian Life Science, stated, “MLS is pleased to have been selected for the cGMP manufacture of a human rhinovirus Type 16 challenge stock. This project, similar to other challenge stocks and vaccines we’ve produced, was an excellent fit for MLS’ core virology and virus-based product manufacturing capabilities. The contract manufacturing process required successful technology transfer and development of a scalable production process to make this challenge stock. MLS and our scientists are proud to be a part of this drug development effort that could significantly reduce the incidence and/or severity of rhinovirus infections.”