manufacture

In-house Manufacture of Cell
Therapy Products for Cancer Treatment

We believe in-house cGMP manufacturing capability will ensure not only the quality and availability of cell therapy products, which is crucial for our clinical success, but also cost-effective manufacturing, which will be crucial for commercial viability. As such, we have constructed and fully equipped our own all-in-one GMP facility in Johor, Malaysia. Built in 2019, the facility was internally validated by completion of manufacturing runs in 2020 and externally audited in 2021 by Malaysian regulatory authority, who is also a member of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (“PIC/S”). Our GMP facility also includes a QC lab to support release of cell products and a R&D lab to conduct staff training and process development. We believe our facility is sufficient to support our planned phase I and II clinical trials.