Strategically Located State-of-the-Art Facilities

Eden Biologics’ headquarter and Center of Excellence is located in Hsinchu, Taiwan. The Center of Excellence has passed EU QP and TFDA audits and is fully-capable of producing material for clinical and commercial purposes for CDMO clients, as well as for our own pipeline.

This site has a cell culture suite equipped with 2 x 50L and 2 x 500L bioreactors, both of which feed into the downstream suite, and Eden can manufacture up to forty 500L-scale batches per year at this facility. All-inclusive Process Development, Analytical Development, Formulation, and in-house QC Labs provide characterization and COA release capabilities under one roof.

Comprehensive Project Management Organization and Master Production Planning ensure the maximum batches per year are being utilized with zero wasted time between changeovers.

Eden’s partner site is located in China’s BioLake Biotech Industry Development Zone. It is notable for being the location of the world’s first GE KUBio facility. The drug substance manufacturing facility was designed and built in Germany as 62 modules, shipped to China by boat, and re-assembled on-site. In 2019, our partner site’s fill-finish facility capable of both liquid and lyophilized fills was completed.

Due to the modular nature of the manufacturing plant, facility capacity can be expanded rapidly and smoothly to meet strong biosimilar demand in Asia, especially China, in commercialization stage. At present, Eden’s partner site has a drug substance production plant, a high-bay warehouse, administrative spaces, and lab spaces for QC and MSAT functions. The facility has been EU QP audited and produced material that has been used in clinical trials in EU, Australia, and China.