Drug development and manufacturing facility
On 2 November 2009, Novartis officially opened its new global technical centre Suzhou Novartis Pharma Technology Co in Riverside Industry Park in the Changshu Economic Development Zone, China.
The facility is located 80km northwest of Shanghai near Yangze River in Jiangsu Province. Novartis started construction of the facility for drug development and production on 24 February 2006.
The company invested $250m in total in a facility for technical R&D as well as active pharmaceutical ingredients (APIs) and intermediates manufacturing.
The decision to invest in the facility was taken to provide additional capacity for the development and manufacturing of intermediates and active pharmaceutical ingredients (APIs) by complementing the existing global network of pharmaceutical technical R&D and production sites.
Novartis expects the facility to become a global strategic supply point for APIs and intermediates by 2010. About 340 associates are employed at the facility.
Novartis acquired the land use right for a 229,000m² site from the Changshu Economic Development Zone for constructing the facility.
The facility includes three production buildings, one R&D facility and other auxiliary facilities. The three production buildings are built on an area of 9,682m² each, covering a total area of 29,046m².
The R&D facility is 10,801m² in size and consists of a pilot plant which is 4,815m² in area and labs, kilo labs and a safety lab spread over 5,986m².
Other auxiliary facilities including offices, warehouses, substation, utilities building, maintenance building, external piperack and tank farm are spread over an area of 27,400m². The site also has modern facilities installed for solvent recovery, waste gas treatment and wastewater treatment.
Novartis plant construction
Construction of the lab building was completed in May 2007. The pilot plant was completed towards the end 2008. The first production building for manufacturing Rasilez/Tekturna was completed in October 2008. The multipurpose production building was completed in June 2009. The second production building for Rasilez/Tekturna intermediates was completed in November 2009.
Installation engineering work carried out during construction included equipment installation, process pipe fabrication and installation. It also included HVAC installation, electrical installation and commissioning, and instrument installation and commissioning. Equipment and pipe antisepsis and insulation, pipes pressure test and flushing/blowing, and system commissioning were also part of the construction activities.
The site has capabilities for process and analytical development. The site will primarily manufacture intermediates and APIs to launch products and in-source selected third-party products.
It will mainly concentrate on Novartis drugs addressing patient needs in the therapeutic areas of hypertension (Rasilez/Tekturna, Esidrex), hepatitis B (Sebivo) and oncology (Glivec), which have a high incidence in China. It will also examine and manufacture chemicals for drugs for leukaemia, epilepsy and other diseases.
The facility will synthesise small amounts of different Novartis developmental APIs in its laboratories to support early-phase pre-clinical development activities (toxicology and formulation development work) in other Novartis sites in Europe and US. It will optimise the manufacturing technology of the products to increase the production quality and quantity. It will also develop safe, cost-effective and environmentally friendly chemical processes that can be used in large-scale manufacture.
The new pharmaceutical development centre was designed by SINOPEC Shanghai Engineering (SSEC), a Chinese company specialising in pharmaceutical, petrochemical and chemical engineering design. Construction of the facility was supervised by Jiangsu Saihua Construction Supervise.
Construction management of the facility was handled by Foster Wheeler. The main contractors for the facility were Nantong Construction Group, building contractors in the Jiangsu province and Shanghai Mechanical & Electrical Installation (SMEIC), a Chinese construction company specialising in the petrochemical, pharmaceutical and infrastructure fields.
State-of-the-art equipment provided by suppliers from China and overseas was installed at the facility. This included high-performance liquid chromatography, nuclear magnetic resonance spectrometers and other equipment for safety testing, production of intermediates and APIs under GMP conditions. The facility also contains reactors, centrifuges, dryers, purified water and a clean room.
Novartis chose to locate the facility in Changshu as the site provided excellent support from the local government and a good talent pool. The location is in close proximity to the Yangtze River, which enables transportation of bulk raw material and also the export of finished products worldwide. Another reason was the emergence of China as a strong chemistry industrial base for chemical development and manufacturing.
Aphena Pharma Solutions announced the expansion of its solid dose division in Cookeville, Tennessee, in September 2020. The project is…
US-based healthcare company Nexus Pharmaceuticals has opened a sterile injectable manufacturing facility in Pleasant Prairie, Kenosha County, Wisconsin. Also known…
In August 2021, California-based biopharmaceutical company Amgen announced plans to build a multi-product drug substance manufacturing plant in Wake County,…
Metrics Contract Services (Metrics), a division of Australian speciality pharmaceutical company Mayne Pharma Group, has expanded its oral solid-dose commercial…