July 1, 2016 (Vol. 36, No. 13)

KUBio Modular Manufacturing Solution Is Based on Single-Use Bioprocessing Technology

JHL Biotech, a biopharma based in Taiwan, recently opened the world’s first KUBio™ modular biopharmaceutical manufacturing facility with single-use bioprocessing technology. JHL will use the KUBio, which was delivered by GE Healthcare and sited in Wuhan, China, to manufacture biosimilars and monoclonal antibodies (mAbs) for late–stage clinical trials and commercial supply. The facility will also provide process development and manufacturing services for JHL’s global customer base.

To learn more about KUBio, GEN spoke to Jan Makela, general manager for bioprocess, GE Healthcare’s Life Sciences business.

JHL Biotech and GE Healthcare partnered to assemble a cGMP-compliant biomanufacturing facility in just 18 months. Speedy assembly was possible because JHL opted to use GE’s KUBio solution, which consists of prefabricated modules. The facility, which is located in China, incorporates single-use technology and is designed to produce biosimilars and monoclonal antibodies.

GEN: A modular factory is something new for GE’s bioprocess-related product line. What led the company to investigate this new concept, develop it, and now place it in China?

Mr. Makela: KUBio was launched in September 2012 to address the increasing worldwide demand for biopharmaceuticals.  Initial modules are configured for the manufacture of monoclonal antibodies. The speed and flexibility of single-use components is now well-recognized across the industry, and GE Healthcare’s know-how in the sector and global footprint makes us ideally placed to harness this potential and package it for rapid deployment wherever a customer requires.

This ease of global access and speed of installation led JHL to select KUBio for its site in Wuhan. Its reason for manufacturing in China is to produce quality, affordable biopharmaceuticals for the region to meet a currently unmet need.

GEN: What motivated JHL to purchase the KUBio factory?

Mr. Makela: According to JHL Biotech’s CEO, Racho Jordanov, JHL was looking to establish manufacturing capacity in Asia with a facility capable of producing biologics to a worldclass standard. As well as the speed of construction and single-use components of a KUBio, JHL selected GE’s modular solution due to its standardized quality, which is of a repeatable cGMP-compliant standard. KUBio is fitted with FlexFactory™ technology, which was of particular interest to JHL Biotech, to complement its FlexFactory in Taiwan. JHL is looking to work with GE again to add a second KUBio as well as fill-finish plant to the Wuhan site. The scalability of the technology and standardization of the facilities will provide seamless tech-transfer.

As an early-stage company, JHL Biotech also benefitted from GE’s complete project management, acting as a single point of contact for JHL. Jordanov appreciated GE Healthcare’s expertise in project management and delivery as being key in completing the factory in just 18 months, exceeding demanding timelines and enabling JHL to accelerate its plans to produce next-generation biotherapeutics locally.

JHL Biotech now has the largest volume of single-use cell culture capacity in Asia with the opening of the new facility.

GEN: What are the main advantages of having such a facility on site?

Mr. Makela: GE Healthcare’s KUBio is a prefabricated facility for monoclonal antibody production that is constructed, assembled and fully fitted-out in 14–18 months, which is an accelerated timeline that is significantly faster than traditional stick-built methods. KUBio also offers a suite of services in addition to the facility including: financial guidance, bioprocessing equipment, project coordination, and product development and qualification and repair services.

The use of GE’s FlexFactory platform means that many elements can be pre-qualified offsite, and that this can be done in parallel with the construction of the facility itself. Also, the manufacture of the modules that make up the facility can be done in parallel with preparation of the greenfield site.

FlexFactory biomanufacturing platform also uses disposable, single-use technologies, eliminating cleaning validation steps, and providing significant time and cost savings. It is also easier to switch production from one therapeutic to another quickly between batches.

The modular and standardized nature of KUBio also makes future expansion of the facility easy to implement, just by adding another KUBio, which can also be replicated at any number of sites in different locations, linked through a single automation platform to provide a global network of KUBios.

GEN: How will working in such a modular factory improve a company’s product development and biomanufacturing activities?

Mr. Makela: The GE FlexFactory installed in the KUBio brings together bioprocessing equipment from the early stages of cell expansion all the way through to the downstream chromatography steps. The FlexFactory comprises technologies such as mixers, bioreactors, filtration and chromatography systems which are integrated through a single automation platform (such as WonderWare or DeltaV).

FlexFactory provides the flexibility to scale-up from process development to commercial production, and is capable of significant production capacity within a small footprint. The KUBio just opened at JHL Biotech’s site in China will be used to manufacture up to 100 kg of monoclonal antibodies per year in 2,000 L single-use bioreactors. Initially, four 2,000 L bioreactors have been installed. The facility is a two-story building with a footprint of roughly 1,200m2, including manufacturing space as well as heating, ventilation, air conditioning, and storage. This output capacity is outstanding for the industry and exemplifies how manufacturers and equipment suppliers are working together to drive up the efficiency and productivity of the manufacture of biopharmaceuticals.

The process control system allows the user to monitor, control, and respond to the real-time performance of the manufacturing process from a number of positions throughout the facility, united with one user interface for simplicity.

GEN Are there any different and specific GMP guidelines that companies need to be aware of in working in this type of facility?

Mr. Makela: The facility is prequalified to a cGMP-compliant standard and the standardized nature of the facility also means that applications for drug approvals are simplified. GE Healthcare handles all approvals with authorities so that the only responsibilities of the customer are the acquisition of the site, getting the appropriate permissions, and preparing it for the KUBio, along with some supporting infrastructure required for the full site set up.

GEN: Are there other announcements coming soon about additional placement of the KuBio modular factory?

Mr. Makela: GE is now building another KUBio (the purchaser has not yet been publicly announced) and is discussing project opportunities in such countries as Brazil, Mexico, South Korea, and Saudi Arabia, among other places

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