PharmaCyte Biotech in final audit of manufacturing site

PharmaCyte Biotech said Monday 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).

LAGUNA HILLS, Calif.–(BUSINESS WIRE)–#INDstatus–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^®, today 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. Both worked closely together to revise the batch records that were generated during the two manufacturing runs that produced PharmaCyte’s clinical trial product for its planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). A batch record is a detailed written document of a manufactured batch of product, prepared during a pharmaceutical manufacturing process. A batch record contains actual data and the step by step process for manufacturing each batch. The completed manufacturing batch records are proof that the two batches were properly made and checked by quality control personnel at Austrianova according to cGMP standards. This was necessary so that the batches comply with the standards required by the U.S. Food and Drug Administration (FDA) for a batch record for each manufacturing run.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “We continue to work through a checklist of items that are necessary to submit an acceptable Investigational New Drug application (IND) to the FDA. The work that cGMP Validation and Austrianova are currently performing to audit the manufacturing facility in Thailand and the work they have completed working together to make certain the batch records meet the cGMP requirements for manufacturing a clinical trial product was and continues to be incredibly detailed and must continue to follow strict FDA guidelines.

“We are extremely pleased that the final audit of the manufacturing facility is underway and that our batch records from the two successful manufacturing runs meet all FDA cGMP requirements as the product is not considered a cGMP product unless it meets these stringent standards.”