ISO 13485 Certified Quality for Developing and Manufacturing Proteins, Antibodies, and Assay Kits

At ASKA Biotech, quality and regulatory compliance are our top priorities. Our certification according to ISO 13485:2016 confirms that our quality management system meets the strict requirements for the development and manufacturing of proteins and immunoassay kits, as well as the analysis of human serum and plasma samples for in vitro diagnostics.

The certification applies to all core service areas – from our Immuno-Services, Antibody Production, and Recombinant Protein Production to our Transfection Solutions. It ensures that our processes are standardized, transparent, and carried out at a consistently high quality level.