Olivier Loeillot, General Manager - GE Asia, describing the KUBio concept.
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KUBio is a prefabricated, cGMP-compliant facility and process solution for scalable and cost- efficient monoclonal antibody (MAb) production. Pre-validated modular units and processing equipment are delivered to your chosen site where they are assembled, qualified, and ready-to-run within 14 to 18 months. This short timeline is achievable because the KUBio solution includes end- to-end support designed to simplify the process.
KUBio utilizes the FlexFactory biomanufacturing platform to reduce operational costs through faster deployment, accelerated production turnaround, multiproduct processing, and scalable production. FlexFactory is comprised of single-use technologies and process hardware integrated through automation. It provides flexible manufacturing capacity and strict manufacturing controls that can be replicated for added process quality and consistency.
KUBio is a turnkey solution for a rapid response to local healthcare requirements. All KUBio modules are produced in accordance with Chinese, European, and American regulatory standards. The resulting cGMP-compliant facility with optimized footprint design is capable of producing 100 kg of MAbs per year.
KUBio facilities are supported by a suite of services that provide comprehensive collaborative assistance.
From the start, GE is the single point of contact. GE project managers coordinate the entire process, engaging GE global reach as needed to facilitate importation, regulatory compliance, and in-country assistance. GE can also provide financial assistance through established lending partners.
Our experienced process engineers can optimize your process development and support analytical development. In addition, cGMP pilot batches can be produced at a GE facility while your KUBio is under construction. Your support continues after commissioning with process transfer, training, and repair services provided on location.
Olivier Loeillot, General Manager - GE Asia and Racho Jordanov, CEO JHL Biotech, explaining the benefits of parallel processes.
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While the 62 modules needed for the facility construction of the KUBio are constructed in Germany JHL was preparing the ground and infrastructure at its site in Wuhan, China and the components of the Single use FlexFactory, were manufactured in Westborough, USA, and in Uppsala, Sweden.
Planning ahead is a critical element for cutting time. Because the conceptual design and most of the basic design is already completed at the time of the investment decision months are gained already at the early start of the project.
More time is gained when the production of the modules is completed while the ground is being prepared at the future facility site.
Delivery of the JHL project
How to build a biopharmaceutical factory in 550 days
Biopharmaceutical organizations like JHL Biotech must quickly attain scalable and cost-efficient manufacturing. To achieve their vision of making high-quality biopharmaceuticals affordable and accessible in China, JHL sought an innovative solution for their new manufacturing facility.
62 prefabricated modules plus one clever innovation from GE Healthcare equals the ideal solution that JHL was looking for.
Value
Manufacturing investment is required 3–4 years prior to building a traditional biopharma manufacturing facility. The drug may only be in Phase II at this stage, so the financial risks are high. Because a KUBio can be constructed in about half the time of a stick-built facility, capital investments are delayed and the risks of Phase I failure mitigated.
Plan
Constructing a new facility can be time consuming and more expensive than originally estimated. GE’s engineers had an idea that would significantly reduce the costs and timing compared to stick- built facilities. This idea is called KUBio.
Build
The modules are produced in a controlled environment for additional quality control. Each module’s design includes the specific materials needed for that room in the KUBio. Electrical, water, and ventilation equipment was installed in JHL’s modules, and factory acceptance testing was performed prior to transport. Process equipment was manufactured and tested at GE before shipping. Simultaneously, JHL prepared the Wuhan site for arrival of their modules.
Transport
GE Healthcare transports the KUBio modules and FlexFactory equipment wherever they are needed, worldwide. For JHL, 62 KUBio modules and 250 FlexFactory components traveled to China from 3 manufacturing facilities in Germany, Sweden, and the US. This journey required coordination of trucks and barges in multiple geographies and was carefully planned with site readiness in Wuhan, China.
Shipping
Trucks transported the modules to a barge for their trip up the Rhine. When they arrived at port, the modules were loaded onto a large ocean vessel for the voyage to Shanghai, China. Upon their arrival in Shanghai, they were loaded onto river barges and traveled up the Yangtze to their final destination.
Assembly
When they arrived in Wuhan, GE assembled the 62 modules into the full facility. In just 8 days, the building was watertight and ready for the installation of 250 pieces of FlexFactory equipment.
Installation
While the modules were en route to China, 250 pieces of FlexFactory processing equipment were manufactured, tested, and shipped. Simultaneously, the on-site team completed the facility’s exterior and certified the KUBio’s readiness for FlexFactory installation.
Validation
In the last weeks GE Healthcare’s Life Sciences has conducted the required commissioning activities ahead of the final validation. GE’s experienced Fast Trak team has validated equipment at the site and trained local JHL Biotech staff on maximizing production.
Ongoing
The JHL Biotech, Inc. Wuhan, China facility is now operational and producing cGMP biologics for global markets. GE KUBio enabled JHL to achieve their vision to make high quality biopharmaceuticals affordable and accessible in China. For an interactive tour of this facility click on the link below.
