On November 28, 2017 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that Eurofins Lancaster Laboratories, a leading Contract Manufacturing Organization that PharmaCyte selected to prepare its Master Cell Bank (MCB), has successfully completed its independent growth evaluation of the cells that PharmaCyte will use in its Cell-in-a-Box-based pancreatic cancer therapy (Press release, PharmaCyte Biotech, NOV 28, 2017, View Source [SID1234522277]). This is a significant step in preparing for PharmaCyte’s pancreatic cancer clinical trial.
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Commenting on the cell testing, PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "The satisfactory completion of this important work by Eurofins is good news. Now the door is open for Eurofins to grow the cells that will be necessary to populate our Master Cell Bank. We have authorized Eurofins to begin production of the MCB. Once that is completed, the MCB will be shipped to Austrianova for encapsulation into what will ultimately become our clinical trial product."
This vital step in the overall product development process has been achieved using the optimal cell culture medium, which has only recently become available. The growth evaluation of the cells is a necessary pre-step to produce the MCB, which is required to comply with FDA guidelines. During the process, Eurofins independently confirmed Austrianova’s selection of cell culture medium for optimal cell growth as well as the growth kinetics of the cells themselves. The cells from the MCB will go on to become the "engine" of the Cell-in-a-Box encapsulated cell product for the treatment of pancreatic cancer.
"We are pleased to be working with Eurofins, who has been both professional and interactive, during this process leading up to what will be the creation of PharmaCyte’s Master Cell Bank of the cells that make up the Cell-in-a-Box encapsulated cell product for the treatment of pancreatic cancer. This step certainly clears the way to produce the MCB," stated Prof. Walter H. Günzburg, Chairman of the Board and Chief Development Officer of Austrianova and PharmaCyte’s Chief Scientific Officer.