Biologics Development
Platform

Quality is the foundation of JHL Biotech’s biologics development platform. 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.
TFDA GMP CertificateTFDA GMP Certificate

Analytical Development

Quality

Process Development

Regulatory Affairs

cGMP Manufacturing

Medical Affairs

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.

WORLD-CLASS BIOLOGICS MANUFACTURING

JHL Biotech has developed its own proprietary CHO-K1 cell line and uses this cell line for its own products and those of contract partners. JHL has established process development expertise that allows fine control of protein characteristics. Our robust development platform and scale-up strategies reliably translate from 3L models to GMP manufacturing at 2,000L, reducing the need for time consuming and costly iterations at full scale. JHL has a comprehensive, state-of-the art analytical portfolio applying orthogonal methods and is capable of developing liquid and lyophilized formulations. Both of JHL’s facilities utilize identical single-use manufacturing technologies provided by GE, Millipore, and other leading vendors. Our unified technical platform simplifies process development, manufacturing, and technical transfer. We have experience manufacturing batches for regulatory submission at, 50L, 200L, 500L, and 2,000L scales and have successfully designed and conducted clinical trials of biologics.

Inside the KUBio - Hallway
Buffer Preparation Area
2000L GE FlexFactory single-use bioreactors
GE ÄKTA Ready Chromatography Systems
Millipore Harvest Skids
Contact us to learn more!