Humanigen Inc (fka HGENQ)

[cowtown jay]

Despite about half of my 20 year manufacturing management career spent working for medical device companies, none of that was related to biotech production, and it has been a struggle for me to get a feel for the manufacturing process.

I now have two more pieces of the puzzle to snap into place, and you provided one of those when Tim (or Ken) responded to your question. I now know that "The production process is 6 - 8 months to grow the cells and fill the vials."

The second thing I learned is that Catalent seems to have made an acquisition to enhance their ability to grow these cells. Today, it was announced that, "RHEINCELL THERAPEUTICS TO BE ACQUIRED BY CATALENT, ACCELERATING THE INDUSTRIALIZATION OF IPSC-BASED THERAPIES...This strategic decision will allow RHEINCELL to continue its growth plans and support the cell and gene therapy industry with leading technology and services."

https://www.rheincell.de/rheincell-therapeutics-to-be-acquired-by-catalent-accelerating-the-industrialization-of-ipsc-based-therapies.html

I've linked the following Catalent video before, because the Catalent representative stated that they can fill 400 vials per minute. But the video actually starts with Catalent's drug substance development team engaged with their cell line expression platform, in which they are expressing monoclonal antibodies. I imagine this is the process that will be augmented by the Rheincell acquisition.

https://www.catalent.com/site-tours/bloomington-in-site-tour-video/

I also re-post a video for anyone who is interested in the Chime expansion, which will be using Humanigen's preferred Cytiva bioreactors. It shows the construction of the modular units being manufactured in Germany, and shipped to Wuhan, as were the bioreactors. The expansion allows Chime to produce 140k liters, and they have agreed to reserve at least 56k liters of that capacity on an on-going basis for lenz.