Biologics and sterile drug manufacturing facility
Thermo Fisher Scientific (Thermo Fisher) will establish a new pharmaceutical services facility for integrated biologics and sterile drug development and manufacturing in Hangzhou, China.
The new good manufacturing practices (GMP)-compliant facility will be a part of Thermo Fisher’s extensive global pharmaceutical services network. It will expand the company’s existing network and enable it to provide drug development and manufacturing services to clients in China and beyond, who require the services in the region.
Thermo Fisher signed a joint venture (JV) agreement with China-based bio-innovation firm Innoforce P-harmaceuticals to establish the new facility in Hangzhou in November 2020. Innoforce will support Thermo Fisher to meet the high biologics demand in China.
The collaboration will support the bio-economy development in Xiaoshan district and Hangzhou. The drug manufacturing facility is scheduled to be completed by 2022.
The new state-of-the-art facility will include strict quality management procedures that either meet or exceed the regulatory guidelines defined by the China National Medical Products Administration (NMPA), the US Food and Drug Administration (FDA), and European Medicines Agency (EMEA).
Thermo Fisher’s new and existing clients can utilise the company’s global network of biologics and steriles in the US, Europe, and Asia-Pacific, until the completion of the new Hangzhou facility. The clients will be smoothly transitioned to the new facility after its completion.
Thermo Fisher Scientific offers more than 1,000 small and large-molecule pharmaceuticals for marketing in more than 70 countries with a full range of development, manufacturing, and clinical trial services.
The services include the development of an appropriate formulation and manufacturing method for active pharmaceutical ingredient (API) or biologics, technology transfer to scale-up clinical trial manufacturing, labelling, packaging, delivery and logistics, and manufacturing and packaging on a commercial scale.
Other key services include drug substances, drug products, viral vector, and clinical trial services.
The company provides a wide variety of specialised formulation, manufacturing, and technical services, as well as scientific expertise and solutions from early stages of product development to regulatory authorisation and commercial-scale production.
The scope of the vector network encompasses the five most frequently used types of viruses, offering broad coverage across the landscape of gene and cell therapy.
Based in the US, Thermo Fisher Scientific serves more than 400,000 clients in the pharmaceutical and biotechnology industry, hospitals, clinical diagnostic centres, institutions, research institutes, and government departments, as well as in environmental, manufacturing safety, and process management settings.
The company deals in four segments broadly, including life sciences solutions, analytical instruments, speciality diagnostics, and laboratory products and services. It has a global workforce of more than 75,000 employees.
The company’s leading brands are Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, and Patheon that offer a unique amalgamation of innovative technologies, accessibility, and pharmaceutical services.
Thermo Fisher made two strategic acquisitions to expand its global services network in 2019. One of them was that of a GlaxoSmithKline’s API manufacturing facility in Cork, Ireland, while the other was that of Brammer Bio, a US-based viral vector manufacturing company.
The objective of Thermo Fisher Scientific is to make consumers more efficient in an intensely challenging business environment and help them overcome their problems.
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