We have built a quality system that that is compliant with the standards of competent regulatory authorities and that is ingrained in the processes we use to make all decisions. Atop this foundation, we have built an approach to biologics development that enables robust, efficient production of a range of mammalian cell-culture derived therapeutics including monoclonal antibodies and enzymes.
Developing protein therapeutics is difficult because they are highly complex molecules that are grown by living cells cultured and cultivated in a precise, reproducible fashion. At JHL, we have mastered the art and science of cell engineering, cell culture, and protein purification.
We have a platform approach to developing biologics that allows us to perform all activities needed to transform biologics from concept to commercial product in-house.
We have developed a standardized “blueprint” for biosimilars development that simplifies the process of making biosimilars to a series of repeatable steps:
- Cell-line development, analytical development, process development, and formulation development at our headquarters and Center of Excellence in Hsinchu, Taiwan.
- Scale-up and large-scale manufacturing at JHL-1, our site in Wuhan, China.