Plasmid DNA Manufacturing Facility
Plasmid DNA Manufacturing Facility | Carlsbad, California
In a world changed by the novel coronavirus (COVID-19), this confidential client had flexibility top of mind when expanding manufacturing capabilities on their Carlsbad, CA campus. The growing demand for mRNA vaccines, as well as cell and gene therapies, necessitated the need for the 67,000-sq.-ft. state-of-the-art facility which was specifically designed for the production of a COVID-19 drug.
The project consisted of a design-build fast-track manufacturing expansion in an existing facility. The space was built to be highly adaptable and include single-use cGMP manufacturing spaces for both vaccine production and plasmid DNA-based therapies. Additional spaces include drug warehousing, laboratories, and office space.
Given the need to get the facility online to meet vaccine production demands, the client selected a design-build delivery method which ultimately cut the schedule from a traditional 18-24 months to an astonishing nine months. The facility was not only delivered in record time for a project of this type but also was delivered under budget.
With a need to begin vaccine production as quickly as possible, the project operated under the guise of “warp speed execution without warp speed designation,” a reference to the U.S. government’s initiative to develop, manufacture, and distribute COVID-19 vaccines.
Selecting design-build as the delivery method expedited the design, permitting and construction process. Early trade partner selection and alignment between the client, architect and contractor secured qualified subcontractors at a time when the pandemic was causing a shortage of skilled workers. By onboarding key subcontractors early in the process, the team was able to optimize the design with installer input, lock-in manpower needs, and procure equipment early, which was especially critical as equipment lead times had been greatly affected by the pandemic.
Flexible and Adaptable
While the purpose of the facility was intended primarily to produce a COVID-19 drug, the client had a goal for the facility to be adaptable for other processes. Aware that approvals for the vaccine coming to market could be delayed or even cancelled, they wanted the facility to be adaptable for production of the many other lifesaving medicines, including plasmid DNA-based therapies.
To make the facility adaptable to current and future needs, the team on-boarded key trade partners, such as design consultants and MEP subcontractors, as early as possible. With input from all trade partners, the team organized clear paths of travel to cleanrooms so that equipment could be switched out with ease. Future planning meant building in excess capacity for HVAC and electrical utilities to allow for increased equipment load. If needed, an abundance of outlets, process gases, purified water systems, and data connections are accessible in the facility without requiring additional upfitting.