Biologics manufacturing facility
BeiGene Biologics is developing a new biologics manufacturing facility in Guangzhou in the Guangdong province of China.
BeiGene Biologics is a joint venture under an agreement signed in March 2017 between BeiGene Hong Kong (95%), a subsidiary of BeiGene, and Guangzhou GET Technology Development (5%), which is an affiliate of Guangzhou Development District (GDD). The company will develop the facility through its subsidiary BeiGene Guangzhou Manufacturing.
The JV will provide financing for the research and development (R&D) of biologics in China in addition to developing the new facility. The total investment in the new facility and R&D is expected to be RMB2.2bn ($330m).
Construction of the facility was initiated in October 2017 and the first phase is expected to be completed and operational in 2019. The new facility will promote high-quality, large-scale manufacturing to increase biologics production and meet the growing demand for BeiGene’s products in the Chinese and global markets.
BeiGene’s biologics manufacturing facility will be located in Sino-Singapore Guangzhou Knowledge City (SSGKC) in GDD in Guangzhou. GDD is one of the initial 14 national economic and technological development zones that were approved by the state council in 1984.
The SSGKC is located roughly 35km away from the Guangzhou city centre and 25km from Guangzhou Baiyun International Airport. It covers 123km² of land, with a start-up area of 6.27km². The SSGKC is aimed at attracting knowledge-based industries, including artificial intelligence, biotechnology and clean technology.
The new facility is expected to enhance the development of the biotechnology industry in the region while promoting its economic growth.
The new biologics facility will be a 24,000l commercial-scale facility developed on a 100,000m² site. It will use GE’s KuBio™ FlexFactory pre-fabricated manufacturing line to manufacture biologics.
The KuBio™ is a single-use configurable modular factory, which bolsters upstream and downstream bioprocessing efficiency at reduced costs. It delivers a prefabricated facility with a ready-to-use production line within 18 months, which is less than the traditional time period of approximately 24 to 36 months. The prefabricated modules can be easily assembled at the site into a functional bioprocessing facility.
The new facility will use genetically modified cell line co-developed and licensed from Boehringer Ingelheim as the core raw material for manufacturing biologics.
BeiGene Biologics will contribute RMB200m ($30m) and GET will contribute RMB1bn ($150m) for the development of the biologics manufacturing facility. GET’s contribution includes cash in equity investment of BeiGene Biologics and a shareholder loan, which may be converted into equity of the JV.
The company has also borrowed RMB1bn ($150m) from a commercial bank for the construction and operation of the facility.
In addition, the Guangzhou government will provide support in the form of funding and providing the right business environment for the development and operation of the facility.
BeiGene awarded the procurement and construction contract to Cockram, while PM Group is responsible for providing site master planning and engineering design services.
PM Group is collaborating with EDRI, a local design institute, to complete the project.
General Electric was contracted to supply its state-of-the-art KuBio™ bio-manufacturing equipment for the new facility.
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