Thanks
@LearningEachDay for posting the videos.
My takeaways from Part 8: Scaling Manufacturing of Cell Therapies. #47417739
Speaker: John McMannis, Mesoblast’s Executive Vice President, Manufacturing.
(My additions in brackets)
10:25 “….
we have completed accrual of phase 3 studies in both chronic heart failure and lower back pain, and we are getting ready to perform the second phase 3 study for both of those studies.”
Have I missed something? Am I the only one surprised by this?
11:50 On manufacturing: “We’ve worked very hard on developing a very robust process that’s gives us the same results, time after time. . . . We’ve got this robust process, which
we believe in one suite we will be able to manage the requirements for GVHD in the U.S. from that one suite, that's in Singapore . . .
We’ve developed a system where we can just keep building more rooms, in order to handle the initial therapies, but we are also looking at scale out, you know (an earlier speaker) referred to the bioreactors, and that’s probably the biggest one,
in the scaling up it's the bioreactors which will give us many more cells and we're working on that too.”
Re coping with the product demand should the Covid trial be successful.
14:00 “We’ve spent a lot of time over the last 3 to 4 months, looking at scale up (meaning bioreactors) because of our Covid trial, if the results continue as they have before, . . . 75% in the Covid trial, we will initially deal with it doing scale out (ie more of the current manufacturing process, not bioreactors), ...
we have developed blueprints in order to be able to hit 10,000 patients in the first 6 months.”
So at this stage, MSB’s are saying their forward planning involves sourcing initial cell supply entirely by conventional processes out of Lonza’s Singapore plant. I wonder whether that will have any political impact in the U.S.?
Also must say I was very impressed by MSB's speakers in these presentations. In good hands.
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I have 19 posters on ignore, 6 of them with 2000+ posts each. Right now MSB is showing 339 posts for the day. I can see about 250 of them. If you haven’t done so already, I suggest you do yourself a favour and put the rubbish on ignore. IMO your HC experience will be considerably enhanced.
Herro
(20min delay)