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Friday, September 20, 2019 10:46:29 PM
Shareholder Update on our clinical trial product and the manufacturing process:
We have a product that we’re completely satisfied with — meaning that the cells we have genetically engineered do exactly what they were designed to do and our encapsulation process is exactly how we want it to be.
? The viability of the cells from our Master Cell Bank is well within the normal range.
? Cells from our Master Cell Bank produce the amount of enzymatic activity we designed them to produce and that is necessary to convert the prodrug we currently use to treat pancreatic cancer from its inactive form to its cancer killing form.
We are satisfied with everything in the “design” of the manufacturing process. We’re now trying to mimic the manufacturing process in Austrianova’s facility in Singapore — which works perfectly every single time — to the upscaled GMP manufacturing process in Austrianova’s manufacturing facility in Thailand. And from recent reports from Austrianova, we are very encouraged.
? As reported to PharmaCyte today, we are in the final days of our first of two back-to-back, staggered manufacturing runs. And everything is going smoothly to this point.
? Also, as reported to PharmaCyte today, the second of the two manufacturing runs is scheduled to begin today. If the first run is successful from start to finish, and all things are mimicked from the first run in this upcoming second run, then we're confident that we'll see a successful second run and then move to release testing.
PharmaCyte will be releasing a recorded version of the today's Shareholder Update Conference Call next week for those who missed the call.
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