Friday, May 30, 2025 9:45:00 PM
froggmister,
All the clues point to manufacturing capacity. Look at what has been announced since the inspections were done by February. The first announcement was about space leased by Advent likely to be utilized as dedicated apheresis capacity then subsequent “acquisition” sign-off on the MIA needed for commercial scale launch. The second announcement was the change in future manufacturing expansion to Class C space indicating that all future ramp up needs to come from Flaskworks not artisan. MHRA sure looks like they are holding out for manufacturing readiness which does not require full validation of Flaskworks (exwannabe’s point) but likely does require solid proof of concept with a unit that does not shed particles (an issue they mentioned as a requirement) and is not held up by any supply chain issues with parts for making them. Supply chain was not mentioned recently but more testing to be done has been once the units are installed. I do not recall any further mention of “shedding” being a concern. Best wishes.
All the clues point to manufacturing capacity. Look at what has been announced since the inspections were done by February. The first announcement was about space leased by Advent likely to be utilized as dedicated apheresis capacity then subsequent “acquisition” sign-off on the MIA needed for commercial scale launch. The second announcement was the change in future manufacturing expansion to Class C space indicating that all future ramp up needs to come from Flaskworks not artisan. MHRA sure looks like they are holding out for manufacturing readiness which does not require full validation of Flaskworks (exwannabe’s point) but likely does require solid proof of concept with a unit that does not shed particles (an issue they mentioned as a requirement) and is not held up by any supply chain issues with parts for making them. Supply chain was not mentioned recently but more testing to be done has been once the units are installed. I do not recall any further mention of “shedding” being a concern. Best wishes.
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