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CALGARY, May 22 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that it has successfully transferred cGMP production for REOLYSIN(R) at the 40-litre batch size to SAFC Pharma(TM), a Division of Sigma-Aldrich Corporation. This follows the successful scale-up from 20 litres to 40 litres announced by the Company last year.
Yields at the 40-litre scale should provide sufficient doses to support future development plans leading to registration and also anticipated early stage commercial requirements. Development work to support further scale-up to the 100-litre level is currently underway.
"Manufacturing at a commercial scale is an integral part of our development plans for REOLYSIN(R)," said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics. "We have built a solid relationship with SAFC Pharma through numerous projects ranging from media optimization to scale up efforts, and we are very pleased to be working with an international leader with a proven track record in biologic manufacturing."
"We are very proud to be Oncolytics' chosen partner for cGMP production of REOLYSIN(R). Consistent with our previous announcement of a $12 million expansion of capacity, we will be in a position to support commercial production of REOLYSIN(R)," said Jeffrey L. Strobel, Ph.D., Site Director at SAFC Pharma's Carlsbad operation. The Carlsbad operation of SAFC Pharma supports the viral vector and vaccine community with its process development and analytical laboratory expertise, as well as its cGMP capability (cell and virus banks, bulk virus manufacturing, and formulated, filled, and finished drug).
About SAFC: SAFC(R) is the custom manufacturing and services group
within Sigma-Aldrich that focuses on high-purity inorganics for high
technology applications, cell culture products and services for
biopharmaceutical manufacturing, biochemical production and the
manufacturing of complex, multi-st
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