Strain and Cell Line Development
Strain and cell line construction takes place in our Research Lab in Taipei, Taiwan. Using expression vectors developed in house, we employ high throughput robotic screens to select candidate clones or cell-lines capable of high-yield production of proteins sharing critical quality attributes with referenced products. Additionally, we optimize culture media and growth conditions with the same objectives in mind.
Our cell line development is distinguished by:
Well characterized mammalian and microbial expression of host strains/cells
Highly efficient expression vector system
High-throughput screening and selection for high productivity cell lines with desired product quality profiles
GMP compliance with Master Cell Bank (MCB) and Working Cell Bank (WCB) productions
Cell Culture and Fermentation
Master cell selection and “seed” development also take place in our Taiwan-based facilities. We develop robust, high-quality, cost-effective, and commercially viable cell culture processes for both mammalian and microbial systems, covering cell banking process definition, scale-up, and generation of toxicology material. These cells are then transferred to our U.S. facility for further development.
Process and Drug Product Development
Process and drug product development are carried out in our San Diego, California facility. Clones and cell-lines received from our Taiwan operation are further optimized for growth, stability, and expression level as well as the physical and biologic properties that are most similar to the reference products.
Our well-developed purification processes support production of material for all early-stage clinical trials as well as commercially viable end product. Our experienced staff defines and develops formulation and delivery systems that maximize drug substance and drug product stability.