Oncolytics Biotech Inc T.ONC

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July 20, 2009 - 

CALGARY, July 20 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has successfully completed its lyophilization (freeze-drying) formulation development program for REOLYSIN(R). (pelareorep)

“This is the final step in the development of our manufacturing process for REOLYSIN,” said Dr. Matt Coffey, Chief Operating Officer for Oncolytics. “Lyophilized product is the standard end use formulation for commercial use of the product.”

Lyophilization: eliminating the need for cold chain logistics

Lyophilization, also known as freeze-drying, is a process being increasingly adopted by in vitro (IVD) assay developers looking to simplify assay handling and storage.

With the challenges of sustainability and the escalating cost of cold chain logistics, lyophilization provides an efficient, effective alternative means of maintaining assay stability.

How can lyophilization overcome the challenges of cold chain?

Cold chain logistics involve the transportation and storage of temperature-sensitive reagents, at a specified and often extremely low temperature. This can be complex, impractical, and expensive. The need for continuous temperature control and monitoring throughout the supply chain can lead to increased risk of product degradation, reduced performance or even complete loss of assay functionality.

Lyophilization offers a solution to these challenges by removing water from the product to the point where it is no longer biologically or chemically active, producing a dry product that can be transported and stored at ambient temperature.

Advantages and disadvantages

Lyophilization presents several advantages over traditional cold chain storage.

Primary benefits include:

- Extended product shelf life: By removing water, lyophilization can significantly prolong the shelf life of assays, enabling permanent storage at ambient temperature without loss of performance.

- Reduced transportation and storage costs: Eliminating the need for refrigeration and temperature-controlled supply chains delivers significant cost savings in transportation, storage and handling.

- Maintained product integrity: Lyophilization reduces the risk of product degradation during transportation and storage, ensuring that the assay maintains its intended performance.

- Enhanced global distribution: The ability to store and transport lyophilized products allows easier distribution to remote areas, particularly in less developed economies with limited infrastructure.

- Substantial reduction in CO² emissions: By obviating the need for refrigeration  the environmental impact of assay transportation and storage is decimated. There is no need for dry ice, there is less energy consumption and less packaging.

Whilst the benefits are compelling, the lyophilization process itself presents some challenges that need to be carefully considered:

- Higher upfront costs: While the long-term savings will be substantial, the initial investment in lyophilization equipment and expertise may be higher than traditional cold chain methods.

- Complexity of the process: The lyophilization process requires specialised knowledge and skilled technicians to optimise the assay design and ensure product quality and consistency.

- Not suitable for all products: Certain products may not be amenable to lyophilization.

Despite this, lyophilization remains a cost effective, sustainable and practical alternative to cold chain logistics, particularly in cases where the transportation and storage of temperature-sensitive products is challenging.