- World-class quality system built by industry veterans
- Quality team leadership has deep industry experience from leading firms including Genentech, Roche, Pfizer, Novartis and Monsanto
- Both JHL facilities passed EU QP audits
- Taiwan facility obtained GMP license post TFDA inspection and Wuhan facility inspected for CFDA CTA submissions by provincial FDA
- Preparations for commercial-approval audits by global authorities well underway (e.g., EMA and USFDA)
- Modern quality management tools including TrackWise, Facility Monitoring System (“FMS”) and an electronic Document Management Program
- Implementing a Laboratory Information Management System (“LIMS”)
We use the highest standards of EMA, US FDA, China FDA, Taiwan FDA, PMDA, HealthCanada, ICH and PIC/s
The treatment of millions of patients around the world will depend on the safe and reliable production of biopharmaceutical medicines. Commitment, skill and experience is vital to help ensure the quality, from the first cell line cloning step to each time a new batch is released. At JHL, robust quality control and a reliable supply of medicines to our partners are the cornerstone of our business.
Compliance to International Standard
JHL Biotech is developing and manufacturing its biosimilar products under the highest standards in the industry. Our facility is designed and built to meet US FDA and Europe EMA standards. Single use technology is used to eliminate risks of cross contamination in fermentation and ensure high quality products.