On June 10, 2020 PharmaCyte 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, reported that it has successfully completed development of the "change history" information and data for CypCaps (2nd generation product) compared to CapCell (1st generation product) (Press release, PharmaCyte Biotech, JUN 10, 2020, View Source [SID1234560973]). 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).
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PharmaCyte’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.
"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.
"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."
The 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 essentially the same as the current one. There can be improvements to the product, but to use the data from the two clinical trials in the 1990s to support PharmaCyte’s Phase 2b clinical trial, it was imperative to develop information and data to support that the two generations of the products are essentially the same – the only difference being improvement to the overall product using the same manufacturing process.
Austrianova also had to gather the data for the release specifications for each generation of encapsulated cells and explain why changes were made and how the changes made for an improved product using the same manufacturing process. Information and data about the capsule maturation and storage were also developed.
In addition, the quality control release assay information and supporting data had to be assembled. This involved capsule diameter; viability of encapsulated cells; sterility; pyrogenicity; potency; cell identity; endotoxins; enzymatic activity; capsule count; label check; and pH.
To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source