Replies to post #654016 on NorthWest Biotherapeutics Inc (NWBO)

[CaptainObvious]

I would think that even manually made batches using the current process have to go through some sort of testing and quality control. Any automated process introduced should be compatible if it meets the same qc standards as the fully manual process. Amiright? If not, why not?

[antihama]

Looking at Dr Bosch’s slide deck and his slides on proteomics, I see the proteomics slides as part of the proof of concept that DCVax will be successful in other tumors. I think our discussion several years ago still holds regarding equivalency:

antihama

Re: flipper44 post# 425283

Thursday, December 16, 2021 11:54:51 AM

Post#
427069
of 654095
The $64,000 question is ‘What type of comparability bridging study is needed? Pre-clinical or clinical? Shorter time-frame or longer? One thought on this board was enlisting 20 or so patients and getting patient consent in order to do a comparison of existing manufacturing to Flashworks manufacturing but if they can characterize the product using in process (non-clinical) testing to compare the 2 manufacturing methods that would greatly move the timeline up. Somewhat akin to using Dissolution testing to compare a tablet made from 2 generic manufacturers. Hmuney post# 426947 and The oNiOnHEAd translation post# 426950 describing the patent on “Methods Related To Activated Dendritic Cells Compositions”, shows that via testing they can characterize the final DCVax product.

The proposed method, including determining the relative amounts of IL-6, IL-8, IL-12 and TNFa and comparing them with threshold values, can be used to increase the immunotherapeutic activity of a population of activated dendritic cells and to determine the effectiveness of immunotherapy in a patient

So from testing the relative amounts of IL-6, IL-8, IL-12 and TNFa, and I’m sure a slew of other tests, they should be able to compare product, and shorten the timeline for Flashworks production. We’ll see.

flipper44

Member Level
Re: antihama post# 427069

Monday, January 03, 2022 3:09:33 PM

Post#
431650
of 654113
Antihama, to answer that question, you might look at the new — May 2021 — MHRA stance on biosimilars, which no longer requires preclinical and/or clinical efficacy studies in most cases. Therefore, if NWBO/Flaskworks is trying to demonstrate biocompatibility with the manual method, logic follows it is a streamlined process. Whoomp, there it is.

https://www.biopharma-reporter.com/Article/2021/05/14/UK-finalises-biosimilar-guidance-designed-to-improve-on-EMA-starting-point