Business
PharmaCyte Biotech Completes Final cGMP Audit of Manufacturing Facility for Pancreatic Cancer Clinical Trial Product
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer
About this update from Pharmacyte Biotech, Inc.
[{"type":"text","content":" LAGUNA HILLS, Calif.--(BUSINESS WIRE)--\nPharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that cGMP Validation, the company’s cGMP consultant, has completed its post manufacturing audit of the manufacturing facility in Thailand and that the facility has successfully passed the audit. This facility is where PharmaCyte’s clinical trial product was manufactured by the company’s partner, Austrianova Singapore (Austrianova). PharmaCyte can now import its clinical trial product to the company’s supply chain vendor in the United States (U.S.) who will then store the product at -80C until it is needed at clinical trial sites.\n\n\nPharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We’re exceedingly pleased that the time consuming and laborious work to conduct the cGMP audit of the manufacturing facility that produced our clinical trial product to cGMP standards has now passed the audit. This is the second independent audit of Austrianova. The first was performed by a different audit company before manufacturing commenced, and the current, just completed audit, was performed after manufacturing concluded. The audit process was particularly laborious and time intensive because of the complexity and length of the manufacturing process using Cell-in-a-Box® technology to manufacture our clinical trial product. We would like to express our appreciation for all of the efforts made by the teams at Austrianova and cGMP Validation to complete the audit in these difficult times working together half-way around the world.”\n\n\nAustrianova’s Chief Executive Officer, Brian Salmons, commented, \"We, too, are pleased that PharmaCyte has successfully completed the comprehensive audit of our facility, processes and manufacturing procedures and records. In total, almost 5000 documents have been generated, reviewed and analysed related to the manufacturing of PharmaCyte’s product using the Cell-in-a-Box® technology. The current audit involved a team of 4 experts from Austrianova and 2 experts from cGMP Validation. We are happy that two independent audit firm have confirmed that Austrianova is operating according to U.S. FDA standards”\n\n\nA cGMP manufacturing facility aud...