Taiwan and China Facilities

JHL Biotech Inc. HQ – Hsinchu, Taiwan

JHL Biotech’s headquarters and Center of Excellence is located in Hsinchu, Taiwan. This site consists of administrative space, analytical development labs, cGMP manufacturing and warehouse spaces, process development labs, formulation development labs, and quality control labs.

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.

Based on GE FlexFactory® Single-use

Purification suites

40 batches of 500L-scale/year

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.

Phase I was completed in May, 2016, and since then, JHL’s Wuhan operations have grown to employ 97 staff, a large percentage of whom are in the QC and Manufacturing groups.

EU QP audited

4 x 2,000L bioreactors

80 batches of 2,000L-scale/year

CAPACITY SUMMARY
Site Glass Applikons GE FlexFactory single-use bioreactors
3L 50L 200L 500L 2000L
Taiwan 20 3 0 2 0
Wuhan 11 3 1 2 4
MFG (Taiwan) Process Dev (China) Commercial (China)
Purpose Development + Phase II* Pre Clinical Development + Sale
Qualified Q1, 2015 Ready Q2, 2015 Q1, 2016
Capacity
Design Batches/year 40 (80) 12-15 80
MAb capacity/year 30 (60) kg 3-4kg 240 kg
Design Standards
21 CFR
Eudralex
PIC/S Annex 13
WHO
Pharmacopeia USP, EP, CP, TP USP, EP, CP USP, EP, CP, TP
Manufacturing Platform
GE FlexFactory® GE/Millipore
Cell Culture 2 (+2) x 500L 1 x 200L 4 x 2,000L
Downstream 3 day at 1.5 kg 2 weeks at 600g 3 day at 6kg

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.