Solvias Expands into Cell and Gene Therapy with HQ in North Carolina
Analytical chemistry lab dedicated to compendial testing and biophysical characterization. It was designed with 12 laboratory benches and three individual bays to house the latest instrument technology. All images: Courtesy of Solvias
Swiss contract research organization Solvias is establishing a cell- and gene-therapy (CGT) testing center in Morrisville, NC, with plans to employ over 170 people by the end of 2025. The company has leased a 50,000 sf facility at Discovery at Perimeter Park, near Research Triangle Park, expanding its reach into CGT and biologics to support advanced cancer and rare disease treatments. The new facility, which will serve as Solvias's North American headquarters, will provide critical analytical services, including cell-based potency assays and next-generation sequencing. Solvias ultimately chose North Carolina over other potential locations due to its strong life sciences ecosystem, research universities, skilled workforce, and business-friendly environment.
The Morrisville site will complement Solvias's existing biologics and CGT facilities in Europe, enhancing its global testing capabilities. CEO Archie Cullen highlighted the site's role in supporting the growing CGT and biologics market, which is projected to experience double-digit growth in the coming years. The company, which has 500 employees at its Swiss headquarters and additional teams in Massachusetts, France, and the Netherlands, provides analytical solutions to over 800 companies worldwide.
The project team consists of JLL (project management, furniture, sustainability), Interior Elements (furniture), SCB (architect), RFD (lab design), WB Engineers (MEP engineer), McAdams (civil engineer), and Barringer Construction (general contractor).
Lab Design News spoke to Solvias’s Steven Smith, general manager US, and Christopher Hepler, site head, about the phased approach to building out the lab facility, unique design features for CGT and biologics testing, and integrating regulatory compliance and sustainability into the facility layout for collaboration.
Q: Can you elaborate on the phased approach to building out the lab facility and how each phase aligns with the company’s goals?
A: While the facility design was conceived as a single 50,000 sf BSL-2 facility holistically, the program team, which included internal Solvias stakeholders and design and construction partners, made the early decision to split the design and build in two overlapping phases. By focusing the initial design and planning on the phase I, 20,000 sf expansion space, the team could learn to work together and build the operating model for overall project management and technical design, and construction of the first phase could proceed in parallel with design of the phase 2, 30,000 sf space. This concept not only facilitated team management and design development, but it also aligned with the overall goal of launching a commercial operation and hiring critical early staff to accelerate the program and commercial go-live.
The decision to phase the program included the following considerations (among many):
Accelerated launch and commercial go-live with core services: Focusing the design, construction, and fit-out of an initial phase of the lab enabled the team to accelerate the timeline from start to commercial operations for certain core services while allowing time to design and build the second phase of the facility in a parallel effort. Moreover, while the business case had clearly defined lab services and capabilities based on customer and commercial input, the two-phased approach provided the team with the ability to incorporate customer and market feedback into the phase 2 design.
Leverage Phase 1 to build the operating and system backbone: Solvias had a very small project team initially in the U.S., and thus had to build not only an organization structure but deploy the quality system, information systems (LIMS, ERP), as well as recruit and hire the lab management and operations team in parallel. The two-phased approach allowed management to focus on building the infrastructure to support the early stages of project execution as well as design and deploy critical systems such as a laboratory information management system (LIMS) which would be critical for long-term operations and quality across the entire site.
Focus on building the initial laboratory management and operating team: As mentioned above, the initial team consisted of a few U.S.-based staff and team members from our home base in Kaiseraugst, Switzerland working with the architect, engineering team, and general contractor. Ultimately, a two-phased design would provide a real-world operating space in the first phase which accelerated recruiting and hiring for key lab personnel who would fit-out, validate, and operate the lab during construction.
Balancing the design and buildout with commercial considerations: The Solvias lab is a complex operation with capabilities which will support a wide range of large molecule and cell and gene therapy modalities. A project split into two phases simplified the marketing and commercial aspects of the project by focusing on the initial service areas.
Phase 2 design flexibility: Created options for flexibility related to the design and fit-out of capabilities for the phase 2 fit-out based on customer feedback and market conditions.
Permitting simplicity and complexity reduction: We went with smaller permit packages for the two-facility construction permits which simplified the permitting process.
Part of the cell-based bioassay lab: two of the six individual bioassay suites and the open area of the lab dedicated to ELISA and other work not requiring a biosafety cabinet (BSC).
Q: What unique design features are being implemented to accommodate the specific needs of CGT and biologics testing?
A:
All the laboratory space is BSL-2 with access to the lab via an airlock
HVAC and air control, with differential pressure
Environmental monitoring and temperature control
Room containment based on lab type and flows
Designed for overall material, people, and waste flow considerations and to maintain lean movement
Q: How is the facility addressing regulatory requirements for CGT and biologics testing within its design and construction?
A: [It was] designed for BSL-2 requirements based on guidance from the CDC:
BSL-2 labs must be designed to be easily cleaned, with negative pressure from adjacent rooms, and have adequate lighting.
Two autoclaves to decontaminate laboratory waste
Limited access to workspace
Seventeen Class 2 biosafety cabinets in six individual cell suites to segregate work
Q: What sustainability practices or technologies are being incorporated into the facility's construction?
A:
Energy reduction: 38 percent reduction in energy usage over typical lab/office building
Water reduction: 37 percent reduction in water usage over typical lab/office building
Healthy materials: Low VOCs, environmental, and material health transparency
Reduced construction waste by 75 percent (four different material waste streams)
Installed air quality monitors
HVAC refrigerant is CFC-free
Q: How has the collaboration with Longfellow Real Estate Partners influenced the design or construction timeline?
A: The collaboration with Longfellow has allowed Solvias to accelerate our move in timelines, aided permitting, and to quickly address any issues that arise. It has been a good partnership that has allowed Solvias to grow into the new facility quickly and efficiently.
Part of the cell-based bioassay lab: An individual bioassay suite and the open area of the lab dedicated to ELISA and other work not requiring a biosafety cabinet. The suite was designed to be fully self-contained with cell counters, incubators, chambers, centrifuges, and microscopes.
Q: What role did proximity to Research Triangle Park and North Carolina’s life sciences ecosystem play in site selection for the facility?
A: Selection was based on an exhaustive review of potential sites in multiple states and locations. The RTP life sciences hub provided not only access to the right technically trained talent with experience in C>, biologics, and cGMP, but great access to vendors, support processes, community support, and good business environment.
Q: How are the design and layout of the facility optimized to support collaboration among scientists and accommodate advanced analytical equipment?
A: The new RTP facility was specifically designed for collaboration with open offices and designated collaboration spaces strategically placed throughout the facility. These spaces have curved writeable walls.
The laboratory space was also designed with advanced analytical equipment in mind. Examples would be a dedicated room designed for transmission electron microscopy (TEM) with separate utility room, and a dedicated Mass Spectrometry room designed to share the utility room with the TEM system.
Q: What strategies are being implemented to attract and retain talent in the local area, and how does the facility design support these efforts?
Facility design was key to attract and retain key talent. Examples of facility design include the following:
Biophillic design to include natural lighting and ventilation and Biomorphic forms and patterns
Diffuse light and shading studies
Lean laboratory design to reduce wasted effort and create efficiencies
Digitization: We adapted our processes to be fully digital, incorporating Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN).
Q: What advanced capabilities, such as next-generation sequencing and cell-based potency assays, will this facility offer, and how were these capabilities considered during the design process?
The new RTP site for Solvias will house advanced and cutting-edge technologies such as next generation sequencing, Transmission Electron Microscopy (TEM), and automated liquid handling, as well as cell-based potency assays with multiple advanced technologies, such as electrochemiluminescence, ultra-sensitive luminescence, and Alpha, HTRF®, LANCE®, and DELFIA® assay technologies.
The design process considered these cutting-edge technologies with one-way directional pass of staff, integrated sample pass-through windows, and strategically placed sample receiving and freezer room locations. Specific rooms were also designed and built for the TEM and mass spectrometry equipment.
Q: How does the new facility complement Solvias’ existing European operations, and what future expansions or innovations are planned to support the company’s growth in CGT and biologics?
A: The new RTP facility complements current European operations with like for like equipment and instruments, shared validated methods, and a shared quality management system (QMS).
