Meet Moderna, Inc. - 2019 Facility of the Future Category Winner
Moderna, Inc. is the 2019 Facility of the Year Category Winner for Facility of the Future for their New cGMP Clinical Manufacturing Facility in Norwood, MA.
Projects selected in this category are recognized for their application and/or implementation of innovative design concepts, new technologies and unique solutions that exemplify the next generation of agile, flexible, efficient and effective new and existing Life Sciences facilities.
Moderna, headquartered in Cambridge, MA, USA is a leader in the discovery and development of messenger RNA (mRNA) therapeutics and vaccines, which are medicines designed to direct the body’s cells to produce intracellular or secreted proteins that can have a therapeutic or preventive benefit for both patients and healthy individuals and have the potential to be an entirely new class of medicines.
Moderna believes that mRNA possesses inherent characteristics could serve as the foundation for a new category of medicines with significant potential to improve the lives of patients and have the potential to help patients in ways that could equal or exceed the impact of recombinant protein-based drugs. With this in mind, Moderna opened its state-of-the-art, early development manufacturing facility in Norwood, MA, in July 2018.
In October 2016, Moderna began the demolition phase of construction for its dedicated in-house manufacturing facility in Norwood. Moderna’s approach was to proactively build capacity in anticipation of the opportunity presented by the power of its discovery platform, from internal research and development, as well as from its strategic collaborators. The site was developed to give Moderna additional control of its supply chain giving the company the ability to provide materials for clinical trials—a key challenge for the company as it scales up to meet the potential of its pipeline and commitment to patients. By fully leveraging the Norwood facility, Moderna expects to be able to supply the materials to support its many clinical trials and its pre-clinical development efforts.
The facility was designed to be highly-flexible, adaptable and capable of manufacturing 100 GMP lots per year for the clinic and 1,000 mRNA orders per month for research. The digital production environment is designed to enable high throughput with a robust and diverse set of products. The enterprise and process control systems are integrated in a manner that enables flexibility and rapid new product introduction in a highly-automated landscape.
Digital technology is integrated throughout the site and includes integration of the enterprise resource planning system with electronic production records, process control systems, the data historian, and laboratory information management system. This digital platform streamlines product manufacturing, testing, and release. It also enables robust data management to support development activities and process characterization.
Moderna is recognized for their design of a facility to provide the capability to support the scale and potential of their pipeline, the design and digital elements which help to reduce the time it takes for the medicines produced at the facility to reach patients for a wide range of diseases that currently cannot be adequately addressed by traditional medicines and the potential impact on patients through rapid deployment of what may become a new category of medicines.
ISPE congratulates the Moderna, Inc. team for their achievements and their FOYA award winning entry for Facility of the Future. Learn more about the 2019 FOYA Facility of the Future Category winner.
Has your company recently designed, built or renovated a state-of-the-art pharmaceutical or biotechnology facility that is best in its class? ISPE is now accepting entries into the 2020 ISPE Facility of the Year Awards (FOYA) Program, and your facility may be eligible to apply. Learn more about the Facility of the Year Awards submission process and your company could be the next Facility of the Year Awards Category winner.
Facility of the Year Awards Banquet
Join ISPE and prominent industry leaders as we recognize the 2019 Facility of the Year Awards (FOYA) Category Winners for their innovation and creativity in pharmaceutical and biotechnology facility design, construction, and operation, at the FOYA Banquet on the evening of Sunday, 27 October 2019 in Las Vegas, NV during the 2019 ISPE Annual Meeting and Expo.