Replies to post #670364 on NorthWest Biotherapeutics Inc (NWBO)

[saxxie2]

Hoffmann just posted the following on ‘X’

Flaskworks: ~$4.33m Well Spent🛠️

Well done to $NWBO, Advent BioServices, and the Flaskworks teams on the progress outlined in today's Flaskworks PR. I'll give a timeline of how we got here and then a summary of today's PR.

August 28, 2020 [1]: $NWBO acquires Flaskworks for $4.33m, of which $1.65m was paid in cash, up to $2.01m paid in stock subject to milestones and $0.67m paid in either cash or stock, or a combination thereof, within 120 days of closing.

“…the Flaskworks system has been developed and tailored specifically for immune cells such as dendritic cells.”

Linda Powers, NW Bio’s CEO commented, “We believe that our DCVax platform technologies are potentially applicable to all types of solid tumor cancers, which comprise the vast majority of all cancers. We are working to build the infrastructure and systems that can enable the scale-up of production to such volumes – and can do so at a price level that will be affordable for widespread use of DCVax treatments.”

March 16, 2021 [2]: $NWBO PR stating they are making progress on the optimization of the Flaskworks system and the buildout of Sawston is being purposely built in phases to time capital costs.

“It is anticipated that implementation of the Flaskworks system will enable the buildout of some or all of the rest of the 88,345 square foot facility, beyond the initial manufacturing suites, to be simplified and streamlined at reduced cost.”

May 12, 2021 PR [3]:

“In addition to the MHRA submission activities, a prototype of the Flaskworks system has been delivered to the Sawston facility, and the Company currently anticipates that initial practice runs with the system may begin at the Sawston facility during the summer.”

February 17, 2022 PR [4]:

“The Company anticipates that Phase 1A of the Sawston facility will have the capacity to produce cancer vaccines for 450-500 patients per year. The Company plans to continue developing the Sawston facility in phases, both to calibrate the capital expenditures with the capacity needed and to leave room for implementation of new technologies such as the Flaskworks system.”

January 6, 2023 PR [5]:

In parallel, R&D work on the Flaskworks system also proceeded, with multiple versions of the system being evaluated, and with a test system established and operating at Sawston. In the US, the Company entered into contract discussions for resumption of manufacturing capacity there.

Further, NWBO stated that a focus of 2023 will be the “continued development of the Flaskworks system, including choice of the system version to take forward.”

February 6, 2024 PR [6]:

THE FLASKWORKS UNIT

✅External vendor engaged to begin the production of GMP-grade Flaskwork units
✅Units mirror the manual process
✅The manufacturing process has been closed
✅Key steps have been automated
✅The units produce substantially the same composition as the manual process
✅The Flaskworks unit is tailored towards dendritic cells whereas other automated systems are not

PATENTS

✅Foundational patent in the US, and in other countries, has been granted
✅Additional patent application has been filed for the new and optimized system features
✅Linda Powers:
"We are also very pleased to have expanded the scope of our patent coverage on the Flaskworks system. We believe this is a valuable asset that will help Northwest Bio build a strong franchise."

FLASKWORKS BENEFITS

✅Flaskworks requires lower grade clean room (grade C labs) that are less expensive to build and operate
✅Currently the manual process only allows one patient’s product to be made at a time, whereas Flaskworks will enable up to 12 products made at the same time
✅The Flaskworks unit will require less expertise and labor to operate

NEXT STEPS

✅A specialized contractor has been engaged to build a GMP compliant version of the Flaskworks prototype. This will take several months.
✅Once the GMP compliant version is complete, Advent BioServices will perform validation and final qualification tests in order to gather data to submit to the regulators for approve the use of the Flaskworks system for the production of #DCVax-L

[ilovetech]

ROS-CH - It's exactly like the difference between how cars were built manually, and how fast car ownership proliferated after Henry Ford innovated with the assembly line. Production scale up exploded and costs went down.

[W_W]

The prototype machine has been successfully completed, and the optimization of the manufacturing process has been also finalized. The design has been frozen. This achievement often marks a significant milestone. (usually we will shout out to everyone)👍️ The focus has now shifted to the production machine manufacturing phase. The goal is to ensure that the products manufactured by the production machine align with those produced by the manual machine. Successful alignment will pave the way for certification.

Importantly, there are currently no known show-stopping issues. This signifies a positive outlook for the project, suggesting that the further development process will see a smooth path. Moving forward, I see the certification process for Flaskworks is much shorter, given the existing certification of the manual process with the benefits from the prior certification of many infrastructure components and the quality control system.