Clinical manufacturing facility
US-based biopharmaceutical company Moderna Therapeutics opened a state-of-the-art good manufacturing practices (GMP) clinical manufacturing facility in Norwood, Massachusetts, in July 2018.
Moderna Therapeutics announced plans to build the facility in September 2016. The construction of the $110m facility was 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 real estate company Campanelli and its partner, venture capital firm TriGate Capital, for 15 years with options for renewal.
Moderna’s cGMP clinical manufacturing facility also won the International Society for Pharmacoepidemiology’s (ISPE) Facility of the Year award in 2019.
The facility 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 by the manufacturing plant.
The GMP mRNA clinical facility is part of Moderna’s early development engine programme intended to advance its innovative class of mRNA drug pipeline. Apart from the facility’s construction, 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 preparing investigative new drug (IND) filings to be submitted to global regulatory authorities. The collaboration with Pharmaceutical Product Development will help design and execute clinical trials to allow 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 several regulatory authorities across the world to advance its programmes through the regulatory processes.
Covering a 200,000ft² total floor space, Moderna’s facility in Norwood offers state-of-the-art integrated end-to-end process facilities. 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. It produces 40 batches of GMP mRNA 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.
Engineering and project management company DPS was awarded a contract to provide architectural, engineering and design services for the facility in October 2016. The contractual scope also includes construction management, commissioning, qualification and validation.
Boston-based architecture and interior design firm 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.
Based in Cambridge, Massachusetts, 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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