EMO Biomedicine was founded in 2004. EMO is the first contract research organization (CRO) that focuses on cell-based assay and therapeutic cell-based product in Taiwan. EMO is one of the qualified CRO for pharmaceuticals declared by Ministry of Economic Affairs, Taiwan.
EMO’s Testing Lab is in compliance with ISO/IEC 17025 and accredited by Taiwan Accreditation Foundation (TAF) and TFDA. The accredited testing scope includes cell-based products, biologics, cell culture supernatant, and whole blood.
EMO’s manufacturing facility and quality management systems for therapeutic cell-based product has been inspected by TFDA for the compliance of Good Tissue Practice (GTP) guidance. In December 2019, EMO’s Cell Processing Unit (CPU) received the certificate of manufacturing MSC-based product from TFDA. EMO is able to offer a complete service, including manufacturing and comprehensive testing, for local and oversea clients.
|2004||EMO Biomedicine Corp. was estabilshed in 2004.|
|2007||EMO obtained the Certificate of Accreditation as a “Testing Laboratory” from Taiwan Accreditation Foundation (TAF), in compliance with ISO/IEC 17025:2005.|
|2009||EMO obtained the certificate of accreditation as a qualified “Drugs Testing Laboratory” from Taiwan FDA.|
|2010||EMO involved in a cell therapy clinical trial and passed the GTP inspection.|
|2016||EMO passed the GTP inspection for RegStem® clinical trial.|
|2016||EMO Received “Excellent Award of Laboratory Biorisk Management System Implementation” from Centers for Disease Control (CDC), Ministry of Health and Welfare, TAIWAN.|
|2019||EMO completed the Phase 1 patient enrollment for RegStem®, a MSCs product, under Taiwan FDA.|
|2019||EMO passed the GTP inspection for RegStem® clinical use according to RASMTE.|
|2019||EMO’s CPU received GTP-compliant certificate from MOHW, according to RASMTE. It is the first passed autologous adipose stem cells CPU for treatment of degenerative arthritis and knee articular cartilage defects in Taiwan.|
|2021||EMO obtained an R.O.C. Invention Patent - USE OF MESENCHYMAL STEM CELLS IN TREATING IMMUNE-RELATED DISEASES, which is EMO independently developed for IDO Quantitative Test to evaluate mesenchymal stem/stromal cells (MSCs) potency.|