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esusun

05/08/19 6:06 PM

#93942 RE: 1234jklm #93939

1234, i generally agree , but i do not think this will be such a time consuming ordeal ; and, everything we are doing (( successes and failures )) are being documented as part of our IND. it is only prudent for PMCB to have all the TEAM ( including Eurofins ) to ensure the cells are the very best they can be ; and they told us they believe they have the fix . PMCB owes up a timely update as to
how the 'FIX' has effected the growth and robustness of the cells .
ASAP .

Soo , to be clear , we are NOT re-creating a new master cell bank !!
However , something in our manufacturing process appears to have caused the cells to be less Robust , and growing more slowly than is acceptable . That is why Eurofins is back in the game , and helping us modify procedure . Again , they said they THINK , HIGHLY LIKELY , they have the FIX.

Soo , now we await response from PMCB as to how well the FIX has worked.

DragonBear

05/09/19 10:04 AM

#93964 RE: 1234jklm #93939

to ensure that the end-products of these manufacturing runs

Assuming there is a concerted effort to try to prepare the mythical IND, we're close to agreeing.

Eurofins most important part would have been the creation of a stable cell line, cloned from the pleomorphic mess they were given. And then characterize the genetics, and enzyme production. Making sure any WCB lines had the same characteristics. Including defining how they would be grown in tissue culture/vat. Then it would be off to Austrianova.

AN creating the WCB, and then performing encapsulation. A lot of variables possibly introduced. Example: Did the encapsulation process affect growth, or genetic stability of the cells? Is the nature of the cell line is that it has random instability in the genetics? Especially when the cells are undergoing encapsulation? Other causes?

The net effect Kenny says everything is ready 18-Sep-18, and it randomly falls apart in Jan. The potential result is a repeat of 2018 testing, and adding to it. As just posted, the biotech sector isn't going to wait with baited fish breath for the Kenny wonder treatment in the next N yrs. Progress is being made elsewhere for PC.