PharmaCyte Biotech, a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced that cGMP Validation, the company’s GMP consultant, is conducting its final audit of the manufacturing facility in Thailand where PharmaCyte’s clinical trial product was produced by PharmaCyte’s partner, Austrianova Singapore (Austrianova).
When the audit is completed, cGMP Validation will give PharmaCyte approval to import the clinical trial product to the company’s supply chain vendor in the United States (U.S.) who will store the product at -80C until it is needed.
In addition, Austrianova and cGMP Validation have now completed their work together to achieve what has been deemed cGMP compliant batch records for the two manufacturing runs successfully produced by Austrianova...
Full text at GMPnews.Net