Theragent CDMO Facility
Theragent - CDMO Facility | Arcadia, CA
The Theragent project utilized an existing office and warehouse building to fit out a new contract development manufacturing organization (CDMO) facility, dedicated to manufacture cell and gene therapies for cancer patients around the world. The 26,000-sq.-ft. warehouse space was redesigned and constructed to include two unique manufacturing areas: GMP-certified modular cleanrooms and supporting lab space.
Client Theragent, Inc.
Design Team AES Clean Technologies
The construction of Theragent’s cleanrooms involved designing and installing an integrated cleanroom system, consisting of four pre-engineered, prefabricated modular “flex suites.” Each suite is equipped with 100% HEPA filtered air circulation units, integrated LED linear lighting, modular wall panels with uPVC finish, material and personnel airlocks, epoxy floors, and designated support space for disinfecting manufacturing products and purified water. All cleanrooms featured a walkable ceiling to help maintain the integrity of a cleanroom environment and to keep all mechanical and ventilation infrastructure accessible for inspection and maintenance.
The project included a 4-degree cold room, -80 degree and liquid nitrogen cryopreservation room, a gas utility room, a final release labeling room, and auxiliary storage space to store reagents, components, and kits. Three robust analytical labs for microbiological studies, quality control operations, and product development testing were also installed. The labs were designed to maximize natural light into the working environment and featured large exterior windows with floor-to-ceiling glass walls along the interior corridors.
The project also involved upgrading the exterior façade and site work for functionality and aesthetics to match the state-of-the-art ambience. Outside, in Theragent’s loading dock, notable additions to the exterior space include new boilers to support the mechanical systems, a standby generator, a liquid nitrogen tank, and storage facility for waste management. A new steel platform stands above the existing roof to support the new air handling units and equipment.
ENR California Best Projects!
The Theragent CDMO facility was named ENR California's Best Manufacturing Project - Southern California for 2022.
National Award of Merit from DBIA
The Theragent CDMO Facility won a National Award of Merit in the Industrial, Process and/or Research Facilities category from the Design-Build Institute of America (DBIA).
The early onboarding of overhead mechanical, electrical, and plumbing (MEP) subcontractors gave the team a platform to coordinate and create a detailed plan to guarantee that all trades had appropriate access to stage their equipment before and after the walkable ceiling was placed. Building information modeling (BIM) information was exchanged and maintained in one location, including models, estimates, and design notes. By the time the team received the permit packages, the model was nearly clash-free and accelerated project construction to successful completion.
To keep the project on schedule, DPR leveraged virtual design and construction tools like laser scanning, 4D visual planning, and aerial capture to build efficiently and ensure safety. DPR also utilized “Dusty Robotics,” a robotic field printer, to print full scale models on the construction surface, based on CAD files of floor and wall layouts. This technology reduced errors, removed ambiguity from any work done by hand, and only required two people to monitor field progress.
Speed-to-market is one of the biggest challenges in constructing certified Good Manufacturing Practice (cGMP) facilities. Theragent’s project mantra of “patients are waiting” was a stark reminder of the high stakes in meeting a tight construction schedule in the life science industry. The design-build delivery method was critical to overcoming permitting challenges, ensuring procurement of raw material was on time, and coordinating multiple construction subcontractors—all factors that significantly impact project timeline. The team successfully completed design, permitting, and construction in 18 months in light of the COVID-19 pandemic (with no stoppage of construction due to any on site COVID outbreaks) in conjunction with trade partners across the country.
DPR’s design-build arrangement kept all subcontractors under one entity, which was a huge timesaver when the team realized that the project had to be broken into three permitting phases – interior, exterior, and superstructure. To meet project timelines, the project team worked closely with City of Arcadia officials to release each phase as early as possible. The team also pushed through an accelerated permit track that separated underground and structural work from the exterior tenant improvement project so all trades could be released sooner. Ultimately, getting the different phases released as early as possible ensured construction deadlines were met and Theragent could begin manufacturing lifesaving immunotherapies for patients in need.
While Theragent’s existing warehouse height of 27’ allowed plenty of space for the walkable ceiling above the cleanrooms, the original roof was not strong enough to support utilities for the cleanrooms.
In conjunction with steel crane operators, the project team successfully installed thirty 220-ton steel beams to support new rooftop HVAC units. The new steel columns were reinforced by horizontal steel bracing that hung just below the interior roof to support the ductwork and above-ceiling MEPs. DPR also ran metal framing from beam to beam and hung drop rods that ran from top frames to flush beams in the walkable ceiling panels. The team also constructed a new mezzanine level with the second story that provided auxiliary storage space for Theragent staff and gave access to the walkable ceiling for Theragent’s facilities team to access the walkable ceiling for performance maintenance.
DPR Construction worked proactively to prevent re-work and re-design of the laboratory and cleanroom utilities. The project team managed and shared a 3D model to identify all in-wall utilities in each room. After labeling all individual plumbing, electrical, communication, control, and lighting utilities, the team put mock-ups of the in-walls in each laboratory and clean room so future users could walk the site, inspect the conditions, and give feedback. After the first walk with the end-users, the team fine-tuned the exact location of each in-wall item. By the second site walk with the users, DPR received sign-off from the client confirming that all utility locations and heights matched their specifications. Together, DPR and Theragent ensured the construction project met all safety, quality, and productivity standards to deliver a world class research and manufacturing facility designed and engineered to produce therapies for patients around the world.
A design-build approach helped navigate sequencing of work and supply chain challenges for more predictable outcomes on the Theragent CDMO Facility.