NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Senti, I have thought that L & D were different products and would each have their own label with their own extensions. I posted that because it gave some credence to Doc’s thoughts, and it’s certainly possible with the updated FDA guidelines.

And by the way, I’m sure that both manufacturing processes are at least partially automated. They will have to be for commercialization, and it’s one of the “pioneering” steps that Linda was referring to. Have you seen the products Advent and Cognate have been working with? According to Lykiiri’s research, Advent has bee working with this:

MicroDEN® Perfusion Platform, Corning Life Sciences

The Corning® MicroDEN® System reduces the cost, time, and variability associated with the manual generation of dendritic cells in well plates and T-flasks.

* Reproducible
* Automated, closed system, optimized for dendritic cells
* Proprietary perfusion culture designed to accommodate adherent and non-adherent culture
* Up to 25 million DCs per run
* Reduces the 11-step manual process to 5 steps
* Translates from well plates and T-flask protocols easily
* Leverages benefits of polystyrene culture surface

Corning MicroDen is a streamlined, perfusion based system programmed to perfuse cell culture media over the dendritic cells during expansion. Through automation, MicroDEN eliminates several steps required to generate dendritic cells (DCs) in the current 'gold standard' manual process. The technician loads the isolated Peripheral Blood Mononuclear Cells (PBMCs) into the system with preferred cell culture medium and incubates. The system supports generation, wash, and harvest of dendritic cells.

The closed system kit reduces the risk of contamination. The cell culture flasks are tissue-culture treated polystyrene for cell adherence and optical clarity.

https://us.vwr.com/store/product/27675745/corning-microden-perfusion-platform-corning-life-sciences



And we know that Cognate has been collaborating with Flodesign Sonics and Terumo BCT., and these are their latest products:


FLODESIGN SONICS® ANNOUNCES THE OFFICIAL COMMERCIAL LAUNCH OF THE FIRST PRODUCT WITHIN THE EKKO™ LINE

This disruptive platform has the ability to process cells in a gentle and efficient way compared to traditional mechanical methods such as centrifugation or spinning membranes.  The first product within the ekko platform has been specifically developed for concentrate and washing applications throughout the process. It is applicable to a range of processes, including single cell suspensions such as T-cells, and cell aggregates that are typically found in pluripotent stem cell cultures.

The ekko platform is a closed and automated system that processes continuously.  Whether preparing an apheresis product for its downstream steps or harvesting cells from a bioreactor, flexible control and design allow for a wide range of process input and final concentrations, yields and process time.  Applications also include buffer exchange and formulation, volume reduction down to 5ml, and single cell depletion for aggregate cell cultures.

https://www.fdsonics.com/index.php/news-events/news/flodesign-sonicsr-announces-official-commercial-launch-first-product-within-ekkotm-line-phacilitate-world-leaders-summit

ARM Presentation by Nina Bauer on Ekko

https://www.fdsonics.com/index.php/news-events/media/flodesign-sonics-presents-alliance-regenerative-medicine-meeting-med



Terumo BCT Launches First-of-its-Kind Device to Accelerate Cell Therapy Manufacturing
FINIA® Fill and Finish System: A New Automation Solution for the Production and Delivery of Cell and Gene Therapy
October 2, 2019

LAKEWOOD, Colo. USA - October 2, 2019 - Terumo BCT's latest cell therapy technology, the Finia Fill and Finish System, is a first-of-its-kind device developed to help bring reproducibility and control to cell therapy manufacturing to get therapies to more patients who need them.
Finia is a fully automated, modular, functionally closed system that creates the final formulation of cell and gene therapies and divides them into user-defined doses for patients. The technology automates a process that is currently manual and labor-intensive with the added risk of error.

"Terumo BCT technologies have been automating the collection and processing of blood and cells for decades," said Antoinette Gawin, President and Chief Executive Officer, Terumo BCT. "Now, we're translating this knowledge to support technology breakthroughs in cell and gene therapies. Finia helps cell therapy developers and researchers simplify processes while increasing accuracy, consistency, reliability and reproducibility -- key to securing regulatory approval."

The Power of Automation
"The production and delivery of cell-based therapies is a complex and logistically challenging process," said Delara Motlagh, Vice President, Cell Therapy Technologies, Terumo BCT. "Developers and manufacturers appreciate support in determining when to automate, which processes to automate and how to integrate automation into their existing process."

Finia combines, mixes and divides the final product into predetermined volumes, all under controlled, refrigerated temperature. It automatically removes air before it seals the final product bags, simplifying the downstream process. Finia also works with Terumo BCT's Cell Processing Application software in the customers' network to facilitate compliance to current good manufacturing practices (cGMP), including electronic recordkeeping, control of process workflow, user credentialing and permission, and guidance of operators through the process with an intuitive user interface module (UIM).

"With Finia, we are expanding our portfolio of automation technologies aimed at this growing industry," said Motlagh. "We are bringing multiphase solutions for cell and gene therapies helping to scale manufacturing and drive toward commercialization to reach larger patient numbers."

https://www.terumo.com/pressrelease/detail/20191002/473/index.html