JHL Biotech’s headquarters 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. This site has a ballroom-style cell culture suite equipped with 2 x 50L and 2 x 500L bioreactors, both of which feed a single downstream, and JHL can manufacture up to forty 500L-scale batches per-year at this facility.
Strategically Located State-of-the-Art Facilities
JHL Biotech Inc. HQ and R&D center – Hsinchu, Taiwan
This World-class facility covers
- Cell Line Development
- Upstream & Downstream Process Development
- Analytical Development
- Formulation Development
- cGMP Manufacturing
- Quality Assurance
- Quality Control
- Purification Suites
- Media and Buffer Preparation Areas
JHL-1 Commercial Manufacturing Plant – Wuhan, China
JHL Biotech’s Wuhan site, called JHL-1, is built on a 2.5 hectare plot of land in Wuhan’s BioLake biotech industry development zone. It is notable for being the location of the world’s first GE KUBio facility. JHL’s KUBio drug substance manufacturing facility was designed and built in Germany as 62 modules, shipped to Wuhan by boat, and re-assembled on-site.
JHL-1 was designed to be constructed in phases. Phase I consists of a GE KUBio drug substance production facility and all infrastructure necessary to produce commercial drug substance. Phase II consists of a fill-finish facility capable of both liquid and lyophilized fills, and Phase III consists of a second KUBio drug substance facility.
Due to the modular nature of the manufacturing facilities, facility capacity can be expanded rapidly and smoothly to meet strong biosimilar demand in Asia, especially China, in commercialization stage.
Groundbreaking Manufacturing Plant
- At present, JHL’s site has a KUBio drug substance production plant, a high-bay warehouse, administrative spaces, and lab spaces for QC and MSAT functions
- Facility has been EU QP audited and produced material that has been used in clinical trials in the EU and Australia
- Capable of annual output of up to eighty batches of drug substance per year (240kg commercial annual capability)
Key Features of the Plant
- Segregated USP/DSP
- 4x 2,000L bioreactors
- Gowning facilities
- Separated post viral processing
- Clean utility systems (WFI/CS/CA)
- HVAC systems and controls
- Segregated upstream and downstream processing areas
- Segregated media buffer preparation and holding areas
- A two-suite purification area for pre-/post-viral processing and bulk filling