Strategically Located State-of-the-Art Facilities

JHL BIOTECH INC. CLINICAL & COMMERCIAL MANUFACTURING PLANT & DEVELOPMENT CENTER – HSINCHU, TAIWAN

JHL Biotech’s headquarter 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 for CDMO clients, as well as for our own pipeline.

This site has a cell culture suite equipped with 2 x 50L and 2 x 500L bioreactors, both of which feed into the downstream suite, and JHL can manufacture up to forty 500L-scale batches per year at this facility. All-inclusive Process Development, Analytical Development, Formulation, and in-house QC Labs provide characterization and COA release capabilities under one roof.

Comprehensive Project Management Organization and Master Production Planning ensure the maximum batches per year are being utilized with zero wasted time between changeovers.

This World-class facility covers

  • Cell Line Development
  • Upstream & Downstream Process Development
  • Analytical Development
  • Formulation Development
  • cGMP Manufacturing
  • Warehouse
  • Quality Assurance
  • Quality Control
  • Utilities
  • Purification Suites
  • Media and Buffer Preparation Areas

JHL WUHAN CLINICAL & COMMERCIAL MANUFACTURING PLANT – WUHAN, CHINA

JHL Biotech’s Wuhan site is located 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. In 2019, JHL Biotech’s Wuhan fill-finish facility capable of both liquid and lyophilized fills was completed and plans for a second onsite KUBio drug substance facility are being mobilized.

Due to the modular nature of the manufacturing plant, facility capacity can be expanded rapidly and smoothly to meet strong biosimilar demand in Asia, especially China, in commercialization stage.

At present, JHL Biotech’s Wuhan site has a KUBio drug substance production plant, a high-bay warehouse, administrative spaces, and lab spaces for QC and MSAT functions. The facility has been EU QP audited and produced material that has been used in clinical trials in EU, Australia, and China. It is capable of an annual output of up to eighty 2000L-scale batches of drug substance per year and employs the same comprehensive PMO and MPP tools for operational excellence.

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

Facility capabilities

  • 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

Impressed? We’d love to work with you!

JHL’s unique regulatory strategy and scale-independent production technologies allow potential partners to apply for Chinese and Global regulatory approvals in parallel.