Replies to post #445343 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Thanks. Automated manufacturing protocols, if done correctly, have better quality control compared to the manual ones.

[dmb2]

hyperopia, you speak like you have experienced 'projects' like this. Your commentary is excellent, thx for the post and the process explanation for all to better understand the undertaking here.

Constructing and transferring while automating has its challenges. In this mfg space, as you well explain, the process is the product and the facility is intertwined into the process. All of this is brought together in the BLA and the challenge and my question is whether the automation (Flaskworks) of the back half of the process will be incorporated into the BLA for quicker capacity ramp post launch or included into a post approval submission, which is more likely given all the moving pieces they are developing. They need a submission cutoff as well as they need good comparative data baselines to work from to demonstrate comparability of results. We won't know the answer until they tell us the plan or give an addl clue.

Thx again and GLTA

[sentiment_stocks]

Hyperopia, I second dmb2’s praise of your excellent and detailed post! Thank you for taking the time to explain how the automated process would work.

Do you think the company ended up validating the Tangential Flow Filtration (TFF) for DCVax-L? I believe they used it for Direct… any color to add here, as (I recall) this was a conversation several of us wondered about here… especially with regards to the last 100 trial entrants.

[dmb2]

hyperopia, I am familiar with Terumo company but not this filling system. I would be most focused on the Flaskworks as the guts of the mfg process, but as you know if every step is not done right there could be critical failures. I have been involved with major fill/finish installations but never worked with systems this modest in scale, I never encountered personalized processing, only larger batch processing. It would be a great assignment to work on this though.

Most BP's have installed SAP as their MES but as you probably also know there are several good alternatives, especially for smaller operations. Good thing these steps and this processing equipment is small scale, but, as you note when you include all NWBO is concurrently doing it is significant and easy to lose time along the way. Today's RA's will require a level of automation that will not allow much contamination risk, and any step highlighted as such in a process risk analysis will require a high set of procedures to protect it and a tight set of tests to monitor it.

The Advent team needs to be good, and so far they have passed muster with their GMP certification. Thx again for the process commentary.

GLTA

[biosectinvestor]

Hmm, what's this?

Planning for commercial scale-out of an autologous cell therapy
A common challenge in the emerging cell and gene therapy industry is translating manual production methods to clinical and commercial-scale manufacturing. Recently, a clinical-stage biopharmaceutical company was looking to commercialize an autologous Dendritic cell therapy, an immunotherapeutic approach for treating and preventing cancers and autoimmune diseases. The company approached Invetech during Phase II clinical trials to commence development of scaled-out GMP manufacturing solutions.

In briefing Invetech, two key challenges were identified:

The therapy needed to be produced consistently and repeatedly at a lower cost
The manual benchtop process was required to be closed in a way that was suited to automation and scale-out yet supported effective biochemistry.
Invetech was engaged to develop a complete manufacturing system that would become the backbone of the client’s entire purpose-built manufacturing facility plans.

https://www.invetechgroup.com/case-studies/autologous-cell-therapy-production/

Many tools are available off the shelf and may have been worked on for some time. I do not expect they need to invent the wheel for every system they need. They did not need to be certified to do that preparatory work either, I expect. I do not know when it will be done, but I'm not underestimating them either.

https://www.prnewswire.com/news-releases/automated-and-closed-cell-therapy-processing-systems-markets-2030-301263072.html

Automated and Closed Cell Therapy Processing Systems Markets, 2030
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Apr 06, 2021, 11:15 ET
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DUBLIN, April 6, 2021 /PRNewswire/ -- The "Automated and Closed Cell Therapy Processing Systems Market By Cell Processing Steps, Scale of Operations, End Users and Geographical Regions: Industry Trends and Global Forecasts, 2020 - 2030" report has been added to ResearchAndMarkets.com's offering.

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Advent Bioservices