A product is defined by the process by which it is made.

To ensure that our product meet up with the desired qualities, quality control and assurance procedures will be focused on the input materials and the procedural stages through the process. For simplicity Critical Quality Attributes; Safety; Purity, Identity and potency as defined by FDA will be looked into. Safety test: BacT/Alert; Mycoplasma detection kit (bacteria) Viral screening FACs (TRA-1-81, Oct3/4antigen surface marker for IPSCs) Purity test: Endotoxin - Limulus Amebocyte Lysate (LAL) assay serum albumin test (ELISA) trypsin and growth factor detection test (ELISA) FACs/Cytometry (SSEA-4, TRA-1-60 and TRA-1-81 IPSCs biomarkers; hematopoietic (CD34); endothelial (CD31); neuroectodermal (CD271) etc.) Identity test: RT-PCR-Gene profiling (DMP1, Col XVII, Col XV, Reln, BMP 4) FACs/Cytometry (CD44, CD166) Osteocalcin/osteopontin assay ALP activity FACs/Cytometry (SSEA-4, TRA-1-60 and TRA-1-81 IPSCs biomarkers; hematopoietic (CD34); endothelial (CD31); neuroectodermal (CD271) etc.) Oct4, Nanog, and Sox2 detection (Western blotting)

CQAs

Potency test: ALP assay/ staining Osteocalcin/osteopontin assay Bone mineralization (alizarin red)