GMP Certified Laboratory
Elvenia Regenerative collaborated with MSC Laboratory who has a GMP facility in Selangor, Malaysia, that has Manufacturing License for Research and clinical trials issued by National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. This facility is located in the heart of Malaysia with access to Hospitals, Research Institutes and Universities to support the Development and Translation of cell-based products from lab to clinics.
Capabilities
Safety Standards
Three (3) sophisticated clean rooms specifically designed for ex-vivo cellular product development and GMP manufacturing.
Licensed
NPRA License to Manufacture Therapeutic Goods for Clinical Trials & Commercial
GMP Facility
GMP – controlled clinical cell cryopreservation and storage facilities
Quality Assurance
Certificate of Analysis
COA will be provided freshly for individual cells delivered with full details on MSCs delivered together with individual QR Code for your clients checking.
Blood Profiling
Will perform blood profiling of the end user (for anti-aging) prior to MSC infusion/injection. One ml of whole blood collection will require to rule out the risk of cancer in the client before MSC to avoid of cells growth.
Data Sheet for MSC Delivered
Besides of COA, our collaborated laboratory provides: