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biosectinvestor

02/07/24 12:11 PM

#670753 RE: skitahoe #670748

The purpose of each cassette is to be a self-contained processing unit. Cassette generally is not part of the basic unit but is a specialized unit.

Cassette basically by definition is a small case or unit that typically is separate from the device in which it is used. The purpose of such a device generally is to be a standardized unit that is replaceable and performs a particular function. In this case, it isolates the processing of the vaccine batches from the external environment but also from the particular mechanisms inside of the Flaskworks machine. This means they don’t have to worry about cross contamination.

In the patent, 11447732, it states “Cell culture systems are configured with interchangeable cartridges, allowing versatility and scalability. Systems are configured to have multiple connected cell culture chambers, which allows parallel processing of different types of cells. Gas-impermeable cell culture chambers and methods for generating cells in closed systems prevent contamination and user error. Methods for recycling cell culture medium provide additional efficiencies….”

Patent 11434459 provides, “Cell culture systems and methods provide improved immunotherapeutic product manufacturing with greater scalability, flexibility, and automation. Cell culture systems are configured with interchangeable cartridges, allowing versatility and scalability. Systems are configured to have multiple connected cell culture chambers, which allows parallel processing of different types of cells. Gas-impermeable cell culture chambers and methods for generating cells in closed systems prevent contamination and user error. Methods for recycling cell culture medium provide additional efficiencies.”

I could go on with the parents. But basically everything is contained for each batch within a cartridge, never coming into contact with the machinery. Cartridges are interchangeable and scalable. And yes, the are separate from the machines themselves. That’s the whole purpose and way in which the process is self-contained and can be done without a clean room.