Cell and gene therapy manufacturing facility
The Center for Breakthrough Medicines, a contract development and manufacturing organisation (CDMO), is developing the world’s largest and most advanced single-point facility for cell and gene therapy manufacturing in King of Prussia, Pennsylvania, US.
The Center for Breakthrough Medicines was formed by current good manufacturing practice (cGMP) manufacturing services provider The Discovery Labs and healthcare investment management firm Deerfield Management Company in January 2020.
A lease agreement was signed to occupy 680,000ft² of area, which represents more than 40% of the 1.6 million ft² biotech, life sciences, and healthcare campus owned by The Discovery Labs in King of Prussia.
The CDMO supports the development of therapies from the pre-clinical stage through clinical and commercialisation within a single facility.
More than 2,000 manufacturing experts, scientists and technicians are expected to be hired in the next 30 months through Nucleus Careers, a cloud-based company specialising in recruiting and retention management.
The facility, being developed with an estimated investment of $1.1bn, is anticipated to be operational by the end of 2020.
Center for Breakthrough Medicines’ facility is located within The Discovery Labs’ campus in King of Prussia near Philadelphia. The campus is designed to support companies involved in healthcare and life sciences.
The Discovery Labs committed an investment of $500m to redevelop the campus by combining the one million ft² former GlaxoSmithKline Upper Merion West Campus and the 640,000ft² Innovation at Renaissance Campus.
The new cell and gene therapy manufacturing facility is located in the heart of the Cellicon Valley.
Discovery Labs’ site is located near interstates and highways such as Route 202, I-76, I-476, I-276 and Route 422. It is also accessible by five major local train stations within a radius of 8.04km.
The manufacturing facility will offer suites for analytical and process development (20), cell banking (two), universal cell bioprocessing (30), viral vector production (ten), plasmids manufacturing (ten) and cGMP testing capabilities (20).
Cell therapy processing and viral vector suites will comply with the standards of regulatory agencies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). All production suites are being designed to cater to the workflows as per the needs of the customers.
The facility will offer cGMP-compliant development and manufacturing of new cell and gene therapies and component raw materials through multi-point technology transfer from early or discovery stage to commercialisation on a single campus.
Custom calibrated equipment will allow the company to meet the quality and compliance needs of clients.
The facility will reduce the time, complexity and cost of developing viral vectors, as well as gene and cell therapies from pre-clinical through commercial-scale production.
The company focuses on providing innovative offerings through partnerships with researchers from academia and industry, while the site will contribute towards making therapies for genetic disorders scalable and affordable.
Cleanrooms at the centre will meet different workflows and configurations of the equipment. The centre will provide both contract research organisation (CRO) and CDMO services. The services covered under the CRO will include the entire scope of clinical trial management needs.
The Colony at the campus will collaborate with scientists from the pharmaceutical industry and academia to advance the development of path-breaking therapies.
It will serve as a platform for researchers to cooperate in custom-built discovery labs. The Colony will support the efforts of the cell and gene therapy experts by providing breakthrough funding, sponsored research deals, as well as cohabitation facilities.
The King of Prussia campus houses a biotech incubator, known as Unite IQ. The incubator, in collaboration with the Pennsylvania Biotechnology Center (PABC), nurtures the development of life sciences start-ups into enterprise companies by providing all the resources required to start operations.
Scientists and companies working at the facility will be able to leverage the capabilities of the Center for Breakthrough Medicines. The existing Innovation Renaissance facility within the campus houses life science organisations. An expansion, Innovation 411, connects to the facility by internal glass corridors.
Innovation 411 is expected to provide additional space of four million ft².
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