Biopharmaceutical manufacture in South Korea
Emerson will automate the first large-scale biopharmaceutical manufacturing facility in South Korea for Celltrion providing engineering services and PlantWeb digital plant architecture
Emerson Process Management will automate the first large-scale biopharmaceutical manufacturing facility in South Korea for Celltrion.
Emerson will provide engineering services and PlantWeb digital plant architecture to help streamline the manufacturing process, increasing output and reducing costs.
In addition to benefiting from leading edge technology to improve operations, Celltrion officials said they selected Emerson for its life sciences experience.
"We are confident and pleased to use Emerson automation expertise and advanced technology to enable us to streamline our manufacturing process, increase reliability and availability, and improve our consistency, quality and service," Celltrion senior vice president Dr Hyun-Soo Lee, said.
Emerson Asia Pacific Life Sciences Engineering Centre in Singapore and a system integrator in Korea will provide engineering design, configuration, documentation, site testing, commissioning and validation support.
Emerson PlantWeb architecture provided for Celltrion will include the DeltaV digital automation system, and the AMS Suite of predictive maintenance software.
The Emerson DeltaV automation system will deliver advanced batch automation.
The AMS Suite software will communicate with smart field instruments including Rosemount pressure, temperature, and flow transmitters; Micro Motion Coriolis flowmeters; and Fisher and Baumann valves with Fisher Fieldvue digital valve controllers.
These smart instruments will use the HART protocol, to enable easy configuration and quick access to process and device diagnostics to aid in faster start-up and operations efficiency.
Audit Trail Software within DeltaV and AMS provides automated documentation to help meet the FDA regulatory requirements of 21 CFR Part 11.
"Celltrion will benefit from high quality, throughput and better plant uptime like that achieved by other life sciences customers," said John Berra, president of Emerson Process Management.
"We are proud to be selected as a partner to provide automation and validation services for what will be one of the largest and most technologically advanced biologic manufacturing facilities in Asia".
The 215,000-square-foot plant will house four 12,500-litre bioreactor systems for clinical to commercial-scale production of protein-based pharmaceuticals that require mammalian cell fermentation.
It will be located on a 23-acre site in the rapidly developing technology park of Songdo New City in Inchon, South Korea.
It will be initially equipped with a total bioreactor capacity of 50,000 litre and is designed to allow expansion to 150,000 litre.
The facility will be ready for commercial operations in mid-2005, subject to regulatory approval.
Celltrion was founded in February 2002.
It is a joint venture between VaxGen and a group of Korean partners, including Nexol Corp, Nexol Biotech Corp, KT and G Corp, and J Stephen and Co Ventures.
The major Celltrion biologics manufacturing facility, a 23-acre site in Inchon, South Korea, will be used to manufacture the VaxGen AIDS vaccine candidates, if licensed, and other biopharmaceutical products.
The facility includes cGMP suites occupying 215,000 square feet for the production of vaccines, monoclonal antibodies and therapeutic proteins.
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