NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

ski, the 2019 ASCO presentation discussed the DCVax-Direct manufacturing process, which of course is personalized, uses tangential flow filtration, and a bagged culture system vs the Flaskworks’ flask culture system. There’s a picture/illustration of the manufacturing system in the slideshow presentation, which you can download here:

https://nwbio.com/program-update-presentation-by-dr-marnix-bosch-at-asco-2019/

The Flaskworks’ system doesn’t eliminate the need for a cleanroom, they will likely be installed in a C-class cleanroom, which is still over 5 times cheaper to operate than a B-class cleanroom. The current Flaskworks’ MicroDen system is designed to be operated inside a conventional incubator, which may be required to control some environmental conditions. The patents state this, and the published study from Northeastern University showed pictures of the system placed inside an incubator.

And by the way, it’s common to have bench-top manufacturing stations set up in a cleanroom, even Kite’s commercial CAR-T manufacturing plant in El Segundo has hundreds of automated systems similar to this:

Large-scale cell manufacturing – The CliniMACS Cell Factory

I have no idea how things remain individual and are automated beyond the FlaskWork device, other than having robots actually handling the FlaskWork cassettes rather than humans. I don't see how anything that's common to many batches of the vaccine can keep each batch completely separate and unique.

As far as what the next evolution of an industrialized manufacturing process could potentially look like for DCVax, there is an example here:

https://www.invetechgroup.com/services/manufacturing-automation-for-cell-therapies/

I'm of the belief that a decade or so from now many personalized products will be approved and far more effective than mass produced therapeutics. I'm hoping that the FlaskWork devices are actually capable of producing many of them. The day may come when such devices are located at most hospitals, or perhaps even in Doctor's offices, and personalized products will be made in short periods of time after patients leave the appropriate sample to make it from.

I doubt the Flaskworks’ system will be deployed at hospitals, but there are a couple companies that have completely closed and automated systems that are capable of manufacturing multiple types of cell therapies that could potentially be produced in a large hospital’s lab in the future. One is Lonza’s Cocoon system shown here:

https://www.biopharma-reporter.com/Article/2020/03/10/Lonza-partners-with-three-institutes-on-Cocoon-system

and the other is the Cell Shuttle system from Cellares. shown here:

https://www.fiercepharma.com/manufacturing/cellares-welcomes-poseida-aboard-cell-shuttle-as-it-closes-out-early-access-program