Excellent work. Thank you. I will need to translate bit by bit but appreciate all the references. Then number of times they changed manufacturers, sources and procedures is absolutely mind boggling. It is really out of control and shows how shoddy this product is and HOW IT HAS NOT IMPROVED by much in 2.5 yrs. There is something there with not only the DNaseI but the other enzymes. They identified and fixed the contaminants in the lipids. How come it didnt happen with the DNase1 etc?
Thanks for linking to my Lipid adduct stuff. More is coming.
whatever process enhancements they spent two years implementing didn't do anything at all. i believe they stonewalled the data becase it showed they shipped terrible product, so instead of improving the quality and thus proving they had knowingly shipped OOS material, they steamrolled through the entire production.
the list of changes to the marketing authorization is in footnote 46. i only cited it to get it out there, but it's definitely a document worth looking at more closely. for example II/0115/G from 3 march 2022 lists a ten-fold downscaling of the batch size! first time i've ever heard of that .
thanks for writing it! i saw some very intriguing stuff looking up UFDF membranes which should relate to ALC production as well, look forward to seeing what you come up with.
Excellent work. Thank you. I will need to translate bit by bit but appreciate all the references. Then number of times they changed manufacturers, sources and procedures is absolutely mind boggling. It is really out of control and shows how shoddy this product is and HOW IT HAS NOT IMPROVED by much in 2.5 yrs. There is something there with not only the DNaseI but the other enzymes. They identified and fixed the contaminants in the lipids. How come it didnt happen with the DNase1 etc?
Thanks for linking to my Lipid adduct stuff. More is coming.
whatever process enhancements they spent two years implementing didn't do anything at all. i believe they stonewalled the data becase it showed they shipped terrible product, so instead of improving the quality and thus proving they had knowingly shipped OOS material, they steamrolled through the entire production.
the list of changes to the marketing authorization is in footnote 46. i only cited it to get it out there, but it's definitely a document worth looking at more closely. for example II/0115/G from 3 march 2022 lists a ten-fold downscaling of the batch size! first time i've ever heard of that .
thanks for writing it! i saw some very intriguing stuff looking up UFDF membranes which should relate to ALC production as well, look forward to seeing what you come up with.
Ah yes. The procedural steps taken? Pages and Pages. A record. Shows its not fit for human (even animal) use, imho.
I think you are too generous to Pharma, lol. I think it is worse than that. Need to think and work on my data and arguments. More soon.