Project Profile: The Ritedose Corporation
The Ritedose Corporation is investing over $17 million to expand its cGMP laboratory capabilities in Columbia, SC, with a two-phase project that will add 10,000 sf of analytical chemistry space and convert existing labs into a 6,000-sf microbiology facility by spring 2026. The expansion—tripling Ritedose’s lab footprint—will create more efficient, purpose-built environments that separate office and wet lab areas, streamline workflows, and enable the company to manage all analytical and microbiological functions in-house.
Designed to support advanced analytical testing and regulatory compliance, the new labs will bolster Ritedose’s expertise in method development, validation, and stability studies, while providing turnkey analytical services such as extractables and leachables, nitrosamine detection, and elemental analysis. This investment strengthens Ritedose’s position as a leading resource for cGMP analytical services, supporting next-generation therapies and expanding its capacity to 2.6 billion doses per year as part of a broader growth strategy that includes new logistics facilities and increased sterile production capacity.
The project team includes CRB (lab planning, design, and construction management), as well as construction trade partners Precision Walls (architectural), Gamewell Mechanical (HVAC, lab utilities, plumbing), Gregory Electric (electrical), Nycom (casework), Loveless Commercial Contracting (concrete), MSS Solutions (miscellaneous steel), and Connecting Elements (furniture).
Lab Design News spoke to Jody Chastain, CEO, and Mohammad Sadeghi, EVP of development and analytical services, about this project.
Q: What key factors influenced Ritedose’s decision to expand its existing cGMP laboratories rather than pursue a completely new build?
A: Since 2024, Ritedose has made substantial investments to expand our internal capabilities and better serve both our clients and the patients who rely on the medications we manufacture. In June, we opened a new logistics and distribution facility that also provides the space to grow our analytical chemistry laboratory into a 10,000-sf, state-of-the-art environment. This expansion creates defined separation between in process wet lab operations and raw materials testing, improving efficiency and workflow.
Our microbiology laboratory will also expand, utilizing the space previously shared with analytical chemistry to strengthen our in-house sterility, compliance, and quality assurance capabilities. Together, these upgrades will triple our laboratory footprint and streamline operations, allowing Ritedose to manage all laboratory functions in-house and deliver fully integrated, turnkey solutions for our customers.
With this expansion, we will no longer need to outsource certain services. We will be able to perform a wide range of analytical services including Leachable and Extractable services, nitrosamine and elemental analyses, as well as drug product de-formulation. The additional space and capabilities strengthen our ability to support complex CMC programs, bioequivalence studies, and regulatory submissions, ensuring that every result aligns with FDA and ICH guidelines. By combining advanced technology with world-class expertise, Ritedose continues to build on its reputation for excellence in cGMP analytical services.
By expanding within our existing infrastructure, we maintain full regulatory compliance while avoiding the potential delays that can accompany new construction and FDA oversight.
Q: How were scientists, lab managers, and other end users involved in shaping the design of the new lab spaces, and what input had the most impact?
A: Lab scientists and management were engaged throughout the design process, which began with ensuring proper placement of safety equipment, quantifying current and projected sample volumes, and designating secure sample storage areas. The team also evaluated the type and number of analytical instruments needed for efficient cGMP operations, assessed supporting utilities and services, and optimized material and personnel flow within the lab.
Q: What is the process for moving personnel, research activities, and ongoing projects into the new laboratory areas while minimizing disruptions?
A: Throughout the process, we do not expect any interruption of services. Ritedose will continue to meet the needs of our clients and the patients we serve. We will qualify the new lab space and put into operation, while we maintain our existing lab at full capacity. Our plan will include installing and qualifying the required laboratory instruments. We may strategically purchase and install some duplicate instruments in the new lab space while our existing facility remains in operation.
Q: How do you approach integrating new laboratory equipment, furniture, and casework into both the new and existing lab spaces to ensure workflow efficiency and safety?
A: From the start, Ritedose approached this expansion with careful planning and integration at every level, ensuring that equipment, casework, and workflow were considered in each decision. To minimize disruption and maintain full operational capacity, the project is being executed in multiple phases.
We will begin by relocating the microbiology laboratory to an existing site equipped with cleanrooms. Doing so will allow us to complete construction of the new analytical chemistry laboratory, followed by the addition of redundant instruments. (This allows us to qualify the new lab while the current lab remains active). Once that's complete, we will vacate the existing analytical lab, allowing us to renovate that space to create a new, expanded home for the microbiology lab. When that's done, the microbiology lab will move into its newly renovated space.
The expanded laboratory will feature cutting-edge instrumentation and is designed to support a full spectrum of analytical testing, from raw material qualification to finished product release. The new configuration will also include dedicated office areas, providing scientists with their own workspace, and establishing a clear separation between lab operations and office environments to enhance efficiency and workflow.
Q: When working with external architects, contractors, or project teams on an expansion of a facility they weren’t originally involved in, what kind of documentation, plans, or background information did Ritedose need to provide to help them understand the existing lab layout and operations?
A: From the start, Ritedose approached this expansion with careful planning and integration at every level to ensure that equipment, casework and workflow were considered in each decision. We provided the external designers and contractors with detailed information to guide the design and layout of the new laboratories. This included the projected volume of samples for both current operations and future growth, the types of instrumentation currently in use and those planned for future integration, and the number of personnel who will occupy and operate within the space.
We also outlined the necessary material, personnel, and water flow streams to ensure efficient and compliant operations. Additionally, we specified requirements for separating testing activities from office areas, as well as for secure sample storage, dedicated glassware storage, and proper waste material handling.
Q: What design strategies were used to enhance adjacencies, workflow, and productivity in the expanded analytical chemistry and microbiology laboratories?
A: The strategy was to promote a clear and open testing space free of ancillary items such as glassware and dishwashing, sample storage, and waste storage, as well as reagent or supplies storage. This approach will allow us to declutter the working space.
Q: How does this expansion position Ritedose to adapt to emerging technologies, evolving regulatory requirements, and future growth in pharmaceutical development?
A: The additional space allows Ritedose to expand its analytical capabilities beyond its current capacity due to space constraints. The new capabilities include in-house E&L studies, material and impurities identification, and characterization.
The expansion will provide our customers with a more turnkey solution from beginning to end, without having any third-party organizations involved. This will make Ritedose a full-service manufacturing facility with its own testing services. Expanding the labs allows us to meet our growth of 2.6 billion+ units, increasing our capacity by about 40 percent.
Staffing this expansion are highly skilled scientists, analytical chemists and industry veterans who bring deep expertise in method development, validation, stability studies, and regulatory compliance. Their collective knowledge and dedication will enable us to deliver even greater value to our clients while ensuring the highest levels of quality, safety, and efficiency and support the full manufacturing capacity at Ritedose.
When the expansions are complete, Ritedose would like to extend these services to the South Carolina ecosystem and provide fully qualified FDA approved lab for analytical purposes.
