Clinical manufacturing facility
Moderna Therapeutics opened its state-of-the-art good manufacturing practices (GMP) clinical manufacturing facility in Norwood, Massachusetts, US, in July 2018.
Moderna Therapeutics announced plans to build the facility in September 2016. Construction of the $110m facility completed in early-2018.
The facility is located in a 200,000ft² building leased at UPLAND, a Class A office and research and development (R&D) building at 100 Tech Drive. The area was rented from Campanelli, a real estate company and its partner TriGate Capital, a venture capital firm, for 15 years with options for renewal.
The cGMP clinical manufacturing facility of Moderna also won the facility of the year (FOYA) award 2019.
It manufactures a range of messenger RNA (mRNA)-based drugs and vaccines for good laboratory practices (GLP) toxicology studies, as well as phase one and two studies.
More than 200 jobs have been created as a result of the manufacturing plant.
GMP mRNA clinical facility is part of Moderna’s early development engine programme aimed at advancing its innovative class of mRNA drug pipeline. Apart from the construction of the new facility, the programme includes collaborations with Charles River Laboratories and Pharmaceutical Product Development.
The collaboration with Charles River Laboratories helps in carrying out GLP toxicology studies and prepare investigative new drug (IND) filings to be submitted to global regulatory authorities. The collaboration with Pharmaceutical Product Development will help to design and execute clinical trials that enable phase one and two clinical studies to be carried out.
Moderna is also developing an automated and digital enterprise by adopting cloud-based applications, which will help in the planning and execution of its mRNA pipeline. The company has also gained knowledge on the requirements of various regulatory authorities across the world to advance its programmes through the regulatory processes.
Moderna’s facility in Norwood offers state-of-the-art integrated end-to-end process facilities in a total floor space of 200,000ft². It includes facilities for GMP manufacturing, pre-clinical operations and testing, a cancer vaccines unit and administrative offices.
The facility performs all manufacturing activities, from raw material production to active pharmaceutical ingredients (APIs), formulation, filling and finish, at one location and produces 40 GMP mRNA lots a year, which can be scaled up to more than 100 GMP mRNA lots in the future.
The site also has the company’s personalised cancer vaccine (PCV) unit for individual supply batches of mRNA for cancer vaccines.
DPS was awarded a contract to provide architectural, engineering and design services for the facility in October 2016. Its contractual scope also includes construction management, commissioning, qualification and validation.
TRIA was awarded a contract to design clinical labs, offices, employee amenities and a conference room for the facility.
The subcontract for piping, heating, ventilation and air conditioning (HVAC ) and plumbing were awarded to Kinetics and Harold Brothers.
Instrumentation and control system infrastructure was provided by Hallam-ICS, while automation and control systems were produced by Siemens.
Moderna selected Hereva Consultants to supervise the design, construction and commissioning.
Headquartered in Cambridge, US, Moderna Therapeutics is one of the world’s leading biotechnological companies.
Founded by Flagship Ventures in 2011, the company offers a range of therapies based on the mRNA drug technology platform targeted at areas such as oncology, immuno-oncology, cardio-metabolic, rare diseases and infectious diseases. A new class of drugs, mRNA therapeutics, generate human proteins and antibodies within patient cells to treat diseases caused by the lack of a fundamental protein.
Moderna is developing its mRNA therapeutics drug pipeline through its ventures focussed on a specific set of areas, namely Onkaido (oncology), Valera (infectious diseases), Elpidera (rare diseases) and Caperna (specific cancer vaccines).
The company has also formed strategic alliances with pharmaceutical and biotech companies such as AstraZeneca, Alexion Pharmaceuticals, Merck, Catalent and Vertex Pharmaceuticals to commercialise its drugs pipeline.
Moderna currently has 21 mRNA pipeline programmes including treatments for multiple forms of cancer, rare diseases, infectious diseases and heart failure.
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