Southwest Research Institute Expands Bioengineering Capacity with New Clinical Supply Facility

SwRI recently broke ground on a new Clinical Supply Facility that will add an additional 21,000 square feet of lab and cleanroom space to its existing 28,000 sf dedicated to pharmaceutical and bioengineering research and development. SwRI assists with drug development from the initial concept phase of discovery through the design and development process up through scale-up for clinical trials and the FDA approval process. Image: Courtesy of Alamo Architects

Southwest Research Institute (SwRI) has officially broken ground on a cutting-edge 21,000 sf Clinical Supply Facility designed to enhance its pharmaceutical and bioengineering research and development capabilities. This new facility, located in San Antonio, Texas, will expand SwRI's lab space and introduce advanced bioengineering production suites featuring cleanroom environments with filtered air and controlled particulate levels. The Clinical Supply Facility will allow SwRI to support clinical trials by producing in vitro stem cells, select vaccines, and small-molecule therapeutics at larger scales. This project bolsters SwRI’s role in San Antonio’s biomedical ecosystem, furthering its contributions to pharmaceutical innovation and bioengineering solutions.

Lab Design News spoke to Darrel Johnston, director of Pharmaceutical and Bioengineering at the Southwest Research Institute, regarding the vision behind the Clinical Supply Facility, SwRI’s latest advancements, and the impact of these initiatives on clients and the broader bioengineering community.

Q: How does the design of this new facility enhance SwRI’s ability to support clients in developing small-batch therapeutics for rare diseases?

A: The new Clinical Supply Facility will give us “walk up access” to an available Good Manufacturing Practices (GMP) suite, allowing us to be very nimble and responsive to production runs with short timelines. Developing pharmaceuticals with chemistry challenges (e.g., low yield, those that require chiral chemistry or the development of new chemistry), is our niche. Finally, we will continue to lead and innovate in formulation.

Q: What role does the facility's design play in adhering to Current Good Manufacturing Practices (CGMP) for both FDA and DEA regulations?

A: Southwest Research Institute is currently an FDA-inspected CGMP manufacturer, licensed by the DEA for controlled substance work. But we currently execute work in up to four separate buildings, with some building-to-building transport of materials or samples. The new facility puts all operations under one roof for a more efficient and controlled workflow.  

SwRI Pharmaceutical and Bioengineering R&D. Video: Courtesy of SwRI

Q: How does the layout of the pilot plant suites and quality control labs promote both efficiency and compliance with regulatory requirements?

A: SwRI has manufacturing areas that have served us well for the last 20 years. The new facility will allow us to segregate activities in a more effective manner. Also, the new, large facility, with receiving, production, quality control analysis, storage, and stability under one roof will minimize transport and handling.

Q: Can you cite some of the lessons learned from this lab project?

A: In our current manufacturing area, we have separate laboratory areas or building for storage, sampling, analysis, and production, which can complicate processes. The layout and flow of any manufacturing facility is of utmost importance with regards to efficiency and optimization, having all operations under one roof improves both. FDA industry standards require adequate space for operations and an orderly placement to prevent mix-ups and contamination of components, raw materials, labeling, and drug substance / drug product. In addition to the expanded space, having separate flow of personnel and materials are an added benefit in the new building layout.

Q: Could you share how the facility will be adaptable for future technologies or advancements in bioengineering and pharmaceutical research?

A: The CSF will include four ISO 7 cleanrooms for bioengineering and bio-related production (biologicals and medical devices). This will allow us to do cell-expansion therapy development, biological reactor development, and medical device manufacture for human-use testing. For pharmaceutical research, the new CGMP suites with 16-foot ceilings all will accommodate taller equipment, which means larger reactors, distillations, and filtrations. This will allow us to reach larger batch sizes for larger clinical trials, or trials requiring higher doses of the active pharmaceutical ingredient. We also will be able to handle flammable solvents and potent materials.