On June 3, 2019 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 its Chief Executive Officer, Kenneth L. Waggoner, and PharmaCyte’s consultant cellular biologist, David Judd, will be on site at Austrianova’s GMP manufacturing facility in Bangkok, Thailand, as the production of its clinical trial material for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) is underway (Press release, PharmaCyte Biotech, JUN 3, 2019, View Source [SID1234536811]).
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Mr. Waggoner and Mr. Judd will observe the culturing of the genetically altered HEK-293 cells both before and after they are encapsulated. Mr. Judd has a broad array of experience in development of cell culture media for many primary cells and cell lines and is particularly knowledgeable in the growth of HEK-293 cells. He has developed manufacturing processes, cell assays, biochemical analysis, cell culture processes and downstream recovery strategies. Although Mr. Judd has already offered advice to both PharmaCyte and Austrianova via telephonic communications, his actual on-site presence should prove to be invaluable. Mr. Judd will lend assistance in helping correct any unforeseen problems in the production process as the latest two staggered manufacturing "runs" are carried out and completed.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "After the changes to the manufacturing process allowed us to get back on track and proceed with GMP production of the "CypCaps," our clinical trial product for the company’s planned clinical trial in LAPC, I felt it was necessary to be on-site with David, our consulting expert in the culture of HEK-293 cells, to oversee the process and ensure we are staying on the path and clinical trial development timeline that we’ve developed to submit our Investigational New Drug application (IND). His presence will be particularly important since this time two manufacturing runs will be performed in a staggered fashion rather than consecutively as has been done in the past."
While in Thailand, Mr. Waggoner, Mr. Judd, Prof. Dr. Walter H. Günzburg and Dr. Brian Salmons of Austrianova and possibly others will be interviewed on the progress of the production, the testing of the clinical trial product, factors involved in the manufacturing process that will be included in the submission of the IND and various other topics related to the company’s planned clinical trial in LAPC.
While on-site at the GMP facility in Thailand, the company expects to post pictures, videos and interviews on its social media platforms. Shareholders and others who are interested in PharmaCyte’s content, should follow the company’s social media platforms:
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