Meridian Life Science, Inc., (MLS) of Memphis, Tennessee, a wholly-owned subsidiary of Meridian Bioscience, Inc. (NASDAQ:VIVO), is proud to announce that MLS manufactured an H1N1 influenza A challenge stock for Immune Targeting Systems, Ltd. Immune Targeting Systems contracted Meridian Life Science to manufacture the influenza A challenge stock resulting in a 12-month, highly collaborative production program culminating in the successful release of the challenge stock. Meridian Life Science manufactured the influenza A challenge stock according to appropriate current Good Manufacturing Practices (cGMP) parts 21 CFR Parts 210 and 211 for use in Phase 1 human clinical trials to the desired specifications and under aggressive timelines; allowing Immune Targeting Systems to meet critical clinical development timelines.
Challenge stocks are infectious viral stocks capable of inducing disease. Challenge stocks permit clinical investigators to conduct carefully controlled studies where the precise timing, route of administration, and dose can be administered to healthy human volunteers with a well defined health history. Challenge studies can be used to test vaccines or therapeutics for efficacy. Traditional infectious disease efficacy studies relying on randomly infected individuals often require treatment of very large numbers of potential participants with incomplete health history information and limited precision regarding the timing of infection. Challenge studies can minimize the number of trial participants required to demonstrate statistical significance, appreciably reduce clinical development costs and speed important vaccines and therapeutics to market.
Victor Van Cleave, Ph.D., Vice President of Research and Development (R&D) at Meridian Life Science, stated, “Meridian is pleased to have been selected by Immune Targeting Systems for the cGMP manufacture of this H1N1 influenza A challenge stock. This project was an excellent fit for Meridian’s core virology and virus based product manufacturing capabilities. The collaboration with Immune Targeting Systems has been a very close partnership with scientists from Immune Targeting Systems working alongside Meridian scientists to ensure successful and timely production of this important clinical research tool. Meridian and our scientists are proud to be a part of this development effort that could significantly impact the incidence and severity of influenza infections.”