There's a great article out in GEN on cell culture process improvement, in particular, the Dr. Yuval Shimoni segment on the "low hanging fruits" of post-licensure improvements.
From the article:
As I didn't go to the conference, I am left thinking that his feat was pretty impressive. Changing media components post-licensure is quite daring.
The biologics license agreement (BLA) will call out the exact ingredients +/- percentages on each media component. And changing a single component can (and has shown to) alter product quality.
Changing several media components, if in fact, that's what he did, is quite the feat and would take testicular fortitude of magnitude 10 on the Moh's scale: Any adverse impact on product quality - no matter the cell productivity improvements - is unwelcome.
Pulling off a media-change post-licensure is not only a technical accomplishment, but a political one as well.
From the article:
At the CHI conference, Dr. Shimoni demonstrated how changes to cell culture media can make a difference by increasing production capacity through greater cellular productivity.
As I didn't go to the conference, I am left thinking that his feat was pretty impressive. Changing media components post-licensure is quite daring. The biologics license agreement (BLA) will call out the exact ingredients +/- percentages on each media component. And changing a single component can (and has shown to) alter product quality.
Changing several media components, if in fact, that's what he did, is quite the feat and would take testicular fortitude of magnitude 10 on the Moh's scale: Any adverse impact on product quality - no matter the cell productivity improvements - is unwelcome.
Pulling off a media-change post-licensure is not only a technical accomplishment, but a political one as well.
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