Replies to post #264 on Oncolytics Biotech Inc. (ONCY)

[onco_investor]

SAFC Sigma-Aldridge contracted as Reolysin manufacturer

SAFC completed their construction of this Viral manufacturing suite capable of 1000 liter batches using disposable Bioreacter technology. IMO this is a very strong statement of confidence that ONCY management feels Reolysin will be approved and is preparing for commercial manufacturing.

From the SAFC news release in Oct 2009

http://www.manufacturingchemist.com/news/article_page/SAFC_Pharma_completes_12m_expansion_in_Carlsbad/43107

SAFC Pharma completes $12m expansion in Carlsbad

SAFC Pharma has expanded its contract manufacturing services for late phase and commercial clients with the completion of an extension to its facility in Carlsbad, California. Validation studies are currently underway and the first production batch is due to run before the end of the year, according to David Feldker, vice president SAFC Pharma.
The US$12m (Euro 8m) project includes the addition of two fully segregated viral product manufacturing suites, built to employ the latest in disposable bioreactor technologies, expanding SAFC Pharma's biologics, viral vaccines and gene therapy manufacturing to commercial-scale quantities.

SAFC Pharma's Carlsbad site specialises in the process development and manufacturing of viral vaccines and viral therapeutics, including a full menu of support services, from preclinical process and analytical development to final fill/finish and commercial bulk drug supplies. The new expansion, designed for multi-lot campaigns, includes dedicated cell expansion, bioreactor production, purification and cleanroom suites.
The addition of 8,000ft2 of manufacturing space to the existing 44,000ft2 site enables both 100-litre batch production in stirred tank bioreactors and 1,000-litre batch manufacturing in disposable bioreactors.

Disposable technology allows you to turn over rooms much more quickly," Feldker explained. "We are handling an infectious product so you really want to make sure it's completely out of the system and disposables can do that."
Designed from the outset as a containment facility, the expansion space is Biosafety Level 2 compliant, allowing manipulation of human pathogens, and allows clients to secure a dedicated suite of cleanrooms for larger scale manufacturing.

"We expect to see a great deal of value in the biologics and viral manufacturing marketplace in the next three to five years generated by two main customer types - those with late clinical phase opportunities but without any in-house manufacturing capability and those with late clinical phase opportunities that have some manufacturing capabilities but may be seeking an additional 'safety net' or wish to avoid additional capital expansion until their technology and drug has proven itself," said Feldker.

[surf1944]

7:40AM Oncolytics Biotech announced publication of preclinical research on synergistic combination of Chemotherapy with Oncolytic Virotherapy (ONCY) 4.35 : The report describes when best to administer taxanes with reovirus to optimize viral delivery to the tumor mass. The researchers demonstrated that this drug combination was superior to either treatment alone, and were able to reproducibly cure nearly half of the treated animals by employing this optimized schedule of paclitaxel/REOLYSIN. "This research supports and further rationalizes the dose schedules currently employed in our ongoing clinical efforts in the phase II and phase III setting," said Matt Coffey, COO of the co.