Moderna Therapeutics, Clinical Manufacturing Facility

DPS and TRIA (a DPS Group company) were engaged by Moderna to provide full EPCMV and architectural design services to complete its new 200,000 sf cGMP clinical manufacturing facility in Norwood, MA.

Location: Massachusetts
Sector: mRNA Vaccines

About This Project

Moderna is pioneering a new class of drugs, messenger RNA Therapeutics, with the vast potential to treat many diseases across a range of drug modalities and therapeutic areas. This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.

Key Attributes

The scope of the project involved the renovation of an existing building and providing facilities for clinical and pre-clinical mRNA manufacturing technology to meet FDA and EMEA standards. DPS completed schematic design, design development, construction documents, construction administration, and early CQV documents. DPS also supported the CM firm with process piping walkdowns as part of their QA. The project includes the following key program areas:

  • mRNA clinical manufacturing
  • Plasmid manufacturing
  • PVU manufacturing
  • Aseptic Fill/Finish manufacturing
  • Pre-clinical labs
  • QC labs
  • Development labs
  • Warehouse/logistics
  • Maintenance

The facility houses three functionalities to support phase I/II clinical trials as well as pre-clinical operations: Plasmid production, mRNA drug substance product, mRNA drug product from fill finish, Personal Vaccine Unit (PVU) and Pre-clinical laboratory. The project adheres to Good Manufacturing Practices (GMP) for medicinal products, devices, and combination products for sale and use in the U.S. and Europe.

Facility of the Year information:

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