Oncolytics Biotech Inc. has announced that it has successfully completed initial scale up of its manufacturing process for REOLYSIN®.
The process improvements and scale up to 40-litre batch size has resulted in increased total yields, which are a result of advancements in the media formulation used in the primary production of REOLYSIN® and in the downstream processing steps required to generate finished product.
The proprietary media formulation was developed by SAFC Biosciences, of Lenexa, Kansas. The scale up of primary production and downstream processing development was undertaken by the National Research Council Biotechnology Research Institute (NRC-BRI) located in Montreal, Canada.
The process at this scale now yields at least 20,000 doses at the maximum clinical dose for intravenous use, or 60,000 doses for local use. Further increases in scale are being investigated. "This enhanced manufacturing process will allow us to keep pace with our rapidly expanding clinical program for REOLYSIN®," said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics.