Oncolytics Biotech reports the successful initial scale-up of the manufacturing process for its anticancer candidate. Reolysin is a formulation of the human reovirus and is in clinical trials for treating Ras-activated tumor cells and some cellular proliferative disorders.
The process improvements and scale up to a 40-L batch size resulted in increased total yields of at least 20,000 doses at the maximum clinical dose for intravenous use or 60,000 doses for local use, notes Matt Coffey, Ph.D., CSO of Oncolytics.
This was achieved through advancements in the media formulation used in the primary production of Reolysin developed by SAFC Biosciences. Additionally, downstream processing steps required to generate finished product were also improved. The scale-up of primary production and downstream processing development was undertaken by the National Research Council Biotechnology Research Institute (NRC-BRI).