This is what I'm referring to from today's release:
Manufacturing using the "closed" Flaskworks system will also enable products for multiple patients (potentially up to a dozen or so) to be produced in a single (larger) manufacturing lab at the same time. Under the present "open" process (as with most cell therapy production processes to date), only 1 patient's product can be made at a time in each manufacturing lab, and the lab must go through special cleaning in between each product.
With the Flaskworks machine performing the manufacturing process steps, the manufacturing personnel will only need to operate and oversee the machine and transfer culture vessels onto and off of the machine for these manufacturing steps rather than performing the steps by hand. This will be crucial for scale up to producing DCVax-L for very large numbers of patients, because the personnel can be drawn from a much wider pool and not just the very limited number of technicians able to perform the process steps by hand in an essentially artisan process.
It's been established that manually it take slightly over a week to make a single batch of the vaccine. With all the special cleaning that must be done between batches, even 50 batches a year is probably optimistic. I'm uncertain where the 500 a year figure you're referring to is coming from, but achieving that would mean more than one batch is being in a day in each cleanroom, I don't believe that's possible.
Every EDEN unit contains the products from one, and only one patient at a time. Unless they've found a way to greatly accelerate what's a biological process, it will take about a week to make each batch. The beauty of the EDEN is that the disposable cassette is completely isolated from the unit itself, once removed a newly filled cassette can replace it immediately, no time is required to clean the EDEN prior to installing the next cassette. Perhaps some maintenance is required, but it should be far faster than cleaning and completely decontaminating a cleanroom.
Gary
