TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company
Transcenta, Biologics, Antibody, Claudin 18.2
2017 - 03 - 14
Hangzhou, China | March 14, 2017 – HJB and G-CON Manufacturing today announced that the companies are working together on HJB’s state of the art biologics facility in the Hangzhou Economic & Technology Development Area (HEDA) in China. Currently under construction, the cGMP facility is expected to be completed and operational in early 2018.
This will be the first commercial facility for HJB, a company formed to significantly reduce the cost of biologics to make them more accessible to a global population. In support of that goal, the HJB plant employs a flexible, rapidly deployable and efficient design that creates a new standard for bioprocessing industry facilities. A key feature in the plant will be the use of G-CON prefabricated cleanroom Pod®. In this application G-CON Pod will be referred to as Pod™, representing the fully equipped processing units capable of running highly intensified bioprocesses. G-CON will simultaneously build multiple Pod® in the U.S. in parallel with construction of the host facility in Hangzhou, to significantly reduce the overall project timeline and facility readiness. Off-site pre-qualification will help abbreviate on-site qualification work once the Pod™ arrive in Hangzhou. Additional Pod® can be quickly deployed, redeployed or repurposed to meet increasing product demand or flexibility requirements. Finally, the facility model will be the foundation for future HJB facilities, reducing the costs and timeline for each subsequent biomanufacturing plant.
The Pod will also feature AES’s Pharma Wall System, an aluminum framed, non-combustible composite panel, featuring a uPVC finish. Such panels will provide a well-known interior finish that will absorb no moisture and is impact resistant. This project will be the first time that G-CON and AES have provided a joint solution since the announcement of their collaboration in April 2016. The facility will be in the Hangzhou Economic & Technology Development Area, an area founded in 1993 as one of China’s first state level development zones. The HEDA is a international industrial, scientific and manufacturing zone producing a number of high value products including biologic drugs, microelectronics, mobile telecommunications, optical equipment products, automobile products, chemicals and computers.
“Pod™ represents the next-generation smart manufacturing platform, providing unique advantages in fast-growing markets like China. Our aspiration is to become an innovation leader and by working with G-CON, we are confident that we will deliver high quality and affordable biologics to more patients worldwide,”
said Yining Zhao, CEO of Just China. “Utilizing G-CON’s Pod technology enables our mission of increasing access to important biologics worldwide. By creating Pod™ we focus our molecular and process technologies into an efficient, integrated design that enables low cost, flexible manufacturing,” said Jim Thomas, President and CEO of Just Biotherapeutics.
Maik Jornitz, CEO and President of G-CON Manufacturing, stated “We are seeing that our flexible, compact Podular cleanroom systems are becoming an attractive and cost efficient alternative for the industry, compared to traditional brick and mortar or stick built systems. Just Biotherapeutics has recognized that those traditional approaches are too inflexible and a principal driver to the higher manufacturing costs. We very much appreciate the teamwork together pursuing our facility innovation for their inaugural commercial scale facility. And we look very much forward continuing the team work to help change the drug manufacturing paradigm.”
G-CON Manufacturing founded in 2009 designs, produces and installs prefabricated, autonomous cleanroom Pod®. G-CON’s cleanroom Pod® portfolio encompasses a variety of different dimensions and purposes, from laboratory environments to personalized medicine and production process platforms. The Pod® cleanroom units are unique from traditional cleanroom structures due to the ease of scalability, mobility and the ability to repurpose the Pod® once the production process reaches the end of its lifecycle. For more information, please visit the Company’s website at www.gconbio.com.
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