Biotechnology company Pharmacyte Biotech Inc (OTCMKTS:PMCB) has successfully developed “change history” information and data for CypCaps™ (2nd generation product) compared to CapCell™ (1st generation product). Pharmacyte Biotech uses its signature live-cell encapsulation technology to develop cellular therapies for cancer and diabetes. The breakthrough is a major milestone and a critical component of the company’s Investigational New Drug application (IND). While evaluating the drug and before granting approval, the US. Food and Drug Administration also considers changes to the manufacturing of the two generations of products. PharmaCyte partnered with Austrianova, which provided the required information and data to satisfy cGMP consultant and meet the compatibility requirements by the FDA for the two generations of encapsulated live human cells. Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte said the partnership was especially important in developing the information and data to meet thresholds for regulatory approvals.
CapCell™ and CypCaps™ Generation Product
The company’s first-generation product was called CapCell™”, while the current product is called “CypCaps™.” Although the two products are made from the same cellulose materials, the 2nd generation product requires a material of higher quality. The differences arise with regard to limiting the level of impurities with microbial and endotoxin and heavy metal levels being below limits in the various literature for powdered cellulose. Additionally, the cellulose is also produced in a more controlled process in the 2nd generation product.
To secure approval from the FDA, companies are required to compare information and data from the same manufactured medicinal product to that of the original product. The two sets of data should be the same. Although improvements are allowed, PharmaCyte’s Phase 2b clinical trial used past data from clinical trials conducted in the 1990s, hence the need to give supporting data and information for the new findings. There is was an improvement to the final product using the same production process.
There was also a separate set of data for each generation to justify the changes made and how they improved product in the same manufacturing process.