Moderna Therapeutics Clinical Manufacturing Facility, Norwood, Massachusetts, United States of America

Moderna Therapeutics Clinical Manufacturing Facility

Moderna Therapeutics announced its plans to construct a state-of-the-art good manufacturing practices (GMP) clinical manufacturing facility in Norwood, Massachusetts, US, on 21 September 2016.

The facility will be developed in a 200,000ft² building leased at UPLAND, a Class A office and research and development (R&D) building at 100 Tech Drive. The space was leased from Campanelli, a real estate company, and its partner TriGate Capital, a venture capital firm, for 15 years with options for renewal.

Construction of the $110m facility is expected to be completed in early-2018. The facility will manufacture a range of messenger RNA (mRNA)-based drugs and vaccines for good laboratory practices (GLP) toxicology studies, as well as phase one and phase two studies.

"Construction of the $110m facility is expected to be completed in early-2018."

Moderna plans to move approximately 100 of its existing employees from its facilities in Cambridge, Massachusetts, to the new facility. The project is also expected to create 120 new jobs, bringing the total number of employees at the facility to approximately 220.

Details of Moderna's Norwood facility

The new 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 will help 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 phase 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 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.

Details of the new GMP mRNA clinical manufacturing facility

Moderna's new facility in Norwood will offer state-of-the-art integrated end-to-end process facilities in a total floor space of 200,000ft². It will include facilities for GMP manufacturing, pre-clinical operations and testing, a cancer vaccines unit, and administrative offices.

The facility will carry out all manufacturing activities, from raw material production to active pharmaceutical ingredients (APIs), formulation, filling and finish, at one location.

Once operational, the facility is expected to produce 40 GMP mRNA lots a year, which can be scaled up to more than 100 GMP mRNA lots in the future.

Contractors involved

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.

Marketing commentary

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 the patient cells to treat diseases caused by the lack of a key protein.

Moderna is developing its mRNA therapeutics drug pipeline through its own 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.