NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

sukus, the approved manufacturing process for DCVax-L that was used during the clinical trials and is currently being used for compassionate use in the UK is a manual “open” process in an A or B-class clean room, where the cells are exposed to the outside (aseptic) clean-room environment. Due to potential cross-contamination and patient mix-up concerns, this process only allows a single patient’s batch to be created at a time. Advent can manufacture four or five patient’s batches in a month in their single suite at the Royal Free Hospital in London.

So if Advent is now using that same manual process in two cleanroom suites at Sawston, then it stands to reason that eight to ten batches could be manufactured in a month. Northwest Bio’s recent PR stated that they anticipate manufacturing 40-45 batches per month at Sawston, so i would assume that some MicroDEN systems will be used. That combined with the additional clue in the 10-K that Advent will be performing equivalency studies using the MicroDEN system.

I wouldn’t get too hung up on the 45 per month number though. It’s just an interim number while they evaluate the MicroDEN system and optimize the manufacturing process. With the size of Sawston, they will not be capacity constrained.