Designing, Building & Operating Manufacturing Facilities for Novel Therapeutics

Design of manufacturing facilities for the production of novel therapeutics requires careful planning and consideration of a myriad of factors, such as throughput, biosafety level, product segregation and contamination control, regulatory environment, time to market, and tech transfer challenges. It is a complex mix of elements and requires a project team that can move quickly and effectively to de-risk the investment and meet market demand.

Recently, many firms have embarked on ambitious programs to bring manufacturing capacity for gene and cell therapies online to meet demand for novel therapeutics. An excellent example is Moderna’s Norwood manufacturing facility for mRNA therapeutics and vaccines completed in July 2018 where DPS and TRIA partnered to provide full architectural, engineering design, and project management services.  The new facility provides the capacity to develop materials for pre-clinical toxicology studies, as well as Phase 1 and Phase 2 clinical development programs, and also has the capability to support new medicines enabled by Moderna’s mRNA platform.

As project architect and engineer of record, DPS provided full engineering design and architecture services for all areas of the facility, including cGMP clinical manufacturing, drug substance suites, formulation, aseptic filling, plasmid production, quality control laboratories, pre-clinical laboratories, toxicology laboratories, and clinical and pre-clinical warehouses. Lab architect and interior designer TRIA was responsible for the office and lab areas for the new facility, including three clinical labs, a glass-walled tour experience showcasing Moderna’s discovery and manufacturing process and an open office environment with flexible seating, collaboration areas and transparency to create visual connections between the office and lab/manufacturing spaces.

Interested in hearing more about this design story in person? Click here to register for a panel discussion sponsored by the ISPE Boston Area Chapter on Thursday, December 6 at Novartis in Cambridge and learn from experts who have recently delivered or are developing facilities and programs for scale up and manufacturing of these novel new therapies. Panelists include:

John Dougherty, Principal Process Engineer, DPS Group

Bankim Patel, Senior Director, Facilities & Engineering, Moderna Therapeutics

Stacy Price, Vice President, Technical Operations, Ziopharm Oncology

Lance Weed, Principal Consultant

Moderated by Jeff Kent, Process Engineer, DPS Group

For more information about Moderna’s new manufacturing facility, click here.