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PharmaCyte Biotech Successfully Develops “Change History” for its Clinical Trial Product for Pancreatic Cancer
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 it has successfully completed development of the “change history” information and data for CypCaps™ (2nd generation product) compared to CapCell™ (1st generation product). The history of the changes to the manufacturing of the two generations of product is a critical component of PharmaCyte’s Investigational New Drug application (IND) and is specifically required by the U.S. Food and Drug Administration (FDA).\n\n\nPharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We are very pleased that our partner Austrianova developed the needed information and data to be in a position to satisfy our cGMP consultant and our regulatory consultant that the information and supporting data should be sufficient to meet the FDA comparability requirements of the two generations of encapsulated live human cells.\n\n\n“The first generation of product was referred to as “CapCell™”, and the current generation of product is referred to as “CypCaps™.” Although the cellulose material is basically the same, a material of improved quality is used in the 2nd generation product. The differences relate to control of impurities with heavy metal content and microbial and endotoxin levels being below the limits in the relevant literature for powdered cellulose. In addition, the production process for the cellulose is more closely controlled in the 2nd generation product. The original cell line used is also now better characterized at the genetic level. Lastly, the encapsulated cells undergo a maturation process in the 2nd generation product and are stored frozen for a longer shelf life.\n\n\n“In short, while both generations of product use the identical cell line, the CypCaps™ have improved quality and control of the cells, improved encapsulation material reproducibility, better controlled cell filling and a much-improved shelf life, resulting in a more robust product overall.”\n\n\nThe FDA requires that all relevant information and data from different generations of the same manufactured medicinal product be compared to one another to ensure that the original manufactured product is es...