Modular Biopharma: Case Study From Wuhan

Transcription

1 Modular Biopharma: Case Study From Wuhan Index Introductions Overview of JHL s Wuhan Operations Design, Build, and Operations (Lessons Learned) Conclusion 1

2 KC Carswell: Brief Introduction Vice President of Process Development at JHL Biotech One of JHL s earliest employees Previous experience in biologics technology and operations at Genentech PhD in Chemical Engineering from Northwestern University / BS in Chemical Engineering from The University of Texas JHL Biotech: Brief Company Introduction JHL is focused on development of biosimilars and also provides contract services to select clients when bandwidth and capacity are available Founded in December of experienced professionals: 126 in Taiwan and 97 in Wuhan US$215 million raised to date from premier financial firms and strategic partners including KPCB, Sequoia, Fidelity, and Sanofi Built and commenced operations at two sites: JHL s headquarters in Hsinchu, Taiwan and JHL s commercial production facility in Wuhan, China Currently developing four biologics, one of which is undergoing a clinical trial in the European Union Entered into a strategic alliance with Sanofi for co development of eight biologics 2

3 Index Introductions Overview of JHL s Wuhan Operations Design, Build, and Operations (Lessons Learned) Conclusion JHL Wuhan Overview 2.5 Hectares Located in Wuhan, China in a biotech hub called BioLake Designed with long term vision for both DS and DP manufacturing capabilities: Phase I (Blue): Administrative building, high bay warehouse, KUBio Drug Substance facility, and utilities Phase II (Yellow): Drug Product production facility Phase III (Red): Additional Drug Substance production facility Phase I construction completed in January 2016 First engineering batch manufactured in June 2016 Administration QC and MSAT Warehouse Fill Finish KUBio I KUBio II Utilities 3

4 KUBio Overview Modular solution chosen because of desire to quickly build and operate a facility that meets the strictest international standards Designed in Germany and shipped to Wuhan via freighter and barge Design capacity of 80 runs per year (assuming two harvests per week) KUBio contains: building, clean utilities, and process equipment 4 x 2,000L GE XCellerex bioreactor trains Millipore harvest integrated Single downstream train: ÄKTA single use technology Downstream Support Formulation Purification Utilities Harvest Upstream 4 x 2,000L 4

5 4 x 2,000L Bioreactor Hall Harvest 5

6 Purification DS Formulation 6

7 Index Introductions Overview of JHL s Wuhan Operations Design, Build, and Operations (Lessons Learned) Conclusion July 2013: Visiting Wuhan 7

8 18 Months: Construction to Completion Modules Constructed in Germany Shipping to China Unloading in Wuhan Reassembly On Site Transportation to Site 不鏽鋼的內框Completed KUBio Move In Equipment Completed KUBio February 25 th, 2016: Site Opening 8

9 Lessons Learned Design Lessons Carefully map out equipment layout and material/motion assessments for simulated process execution footprint only increments modularly Consider impact of equipment design for single or multiple process requirements Consider how Kubio will interface with locally designed/built elements for facility and utilities Implementation Lessons Communicate early and often with Local Authorities: Changes in local fire code standards during the project resulted in re work. Ensure paperwork for import meets local customs requirements Be prepared to source locally: Due to strict import rules, we ended up sourcing solvents and certain other building materials from local sources. Index Introductions Overview of JHL s Wuhan Operations Lessons From Design, Build, and Operations Conclusion 9

10 Conclusion GE can deliver a complete manufacturing solution to a small, fast growth company that doesn t have full in house resources to handle design and construction of a manufacturing plant The KUBio is a great solution for quickly establishing operations in emerging markets, just ensure the local interfaces are managed appropriately Design and construction of a KUBio facility can be accelerated through local sourcing and communications with local authorities Thank you! 10