NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

alphapuppy, they are not just starting to use GMP materials and methods; they always have. However, this is a brand-new bespoke system, which was recently designed and developed on the fly as they worked out the best configurations over the past year with the various GMP components (centrifuge, motors, culture cartridge, sensors, media bottles, perfusion tubes, etc.) which are basically the “guts” of the system.

I’m guessing that once that was worked out, they had to design a new housing unit to put all the components into. The single-use GMP plastic components like culture cartridge, sensors, and tubes, will be sourced from Saint Gobain, which has already been established, while the new housing unit, motors, etc., will be sourced from a new, special contractor that’s familiar with GMP design and materials for clinical use. For example, this means that the materials must not release or leach any substances that could damage the product, it must also be smooth so it could be cleaned easily, with surfaces free from grooves or cracks where bacteria or contaminants could gather, and joints and seams have strict requirements, etcetera. In case you haven’t seen it, this was the first prototype, just to give you an idea of the type of specifications that would be given to the new vendor.