When I said the Flaskworks’ system is ready for commercial production, I meant that the system has completed the validation processes and comparability study, and can now consistently meet commercial standards. The automated process using the Flaskworks system will still need to be approved by the MHRA.
The entire reason Northwest Bio acquired Flaskworks in the first place is because it’s necessary to automate the culturing process to commercialize DCVax. The manufacturing process must be automated and digitized for several reasons: to improve consistency and reduce risk to meet higher commercial regulatory requirements, to lower manufacturing costs, and to scale production for commercial volumes that are not possible with manual production. Flaskworks/Advent has spent the past two years upgrading and developing the system from a clinical device to a commercial device, testing, validating, and optimizing it for commercial use at Sawston, and incorporating it into an automated process to manufacture DCVax.
Shashi Murthy’s ASCO presentation explained the automated manufacturing process: first, the monocytes are isolated in the Gibco CTS Rotea cell processing system, next culturing, lysate pulsing, maturation, and washing in the Flaskworks system, and finally filling the final doses into cryovials in the new automated fill and finish system. The most critical component of that automated manufacturing work flow is the Flaskworks’ system.
As I’ve previously posted and the PR states, the GMP for a commercial product are far more stringent than for an investigational product. Quality is designed and built into the commercial manufacturing process at every step. Risk assessment/process validation studies must be performed on each process to provide evidence that every process will operate in a state of control, which ensures a consistent and high quality product.
Advent has not spent the past year validating an obsolete, inefficient, manual culture process which requires 15 expensive man hours, is subject to potential contamination risk, and requires an expensive high grade cleanroom.
It’s crystal clear to me that Advent intends to use the automated process that includes the Flaskworks system to apply for the commercial license at Sawston. I have zero doubt.
And by the way, for anyone that says this commercial license has nothing to do with Northwest Bio, that is ridiculous and completely false. This commercial license has everything to do with Northwest Bio. Advent has to demonstrate their ability to manufacture, store, and distribute in compliance with GMP for a commercial product. That commercial product is Northwest Bio’s DCVax-L.
