Southwest Research Institute (SwRI; San Antonio, Tex.) broke ground on a new 21,000-square-foot Clinical Supply Facility to support government and industry clients with integrated pharmaceutical and bioengineering research and development.
“The new facility expands our bioengineering laboratory footprint and adds dedicated bioengineering production suites with filtered air and low airborne particulate counts,” said Darrel Johnston, director of SwRI’s Pharmaceutical and Bioengineering Department. “The Clinical Supply Facility will allow us to produce in vitro stem cells, certain types of vaccines and small molecule therapeutics in a clean environment at scales able to facilitate clinical trials for our clients.”
SwRI plays an important role in San Antonio’s highly collaborative biomedical ecosystem. As a pioneer in microencapsulation, bioengineering and pharmaceutical development, the Institute can assist clients with important research and development projects of all sizes, including small batches of therapeutics for rare diseases involving fewer than 200 units.
“We help develop clinical supplies both for active pharmaceutical ingredients as well as the formulated products needed for clinical studies,” said Dr. Joe McDonough, vice president of SwRI’s Chemistry and Chemical Engineering Division. “SwRI can guide clients step-by-step from the initial concept phase through drug discovery and the FDA approvals process. Using our expansive facilities, we support our clients with the development of their clinical supplies.”
SwRI’s Rhodium™ docking platform accelerates the drug discovery process by screening millions of compounds to identify the best potential candidates. Developed over a decade ago, Rhodium identified potential treatments during the COVID-19 pandemic. Institute researchers are now using Rhodium in the drug discovery process for other viruses and for DNA-targeting therapeutics to advance cancer research. Also, an SwRI-developed bioreactor can assist clients with the development of novel biotherapeutics.
“The new pilot plant facility will provide three new Current Good Manufacturing Practices pilot plant suites and quality control labs all under one roof. This will improve workplace and regulatory efficiency to provide the space needed to serve more clients locally, nationally and internationally,” said Johnston.
The Institute adheres to Current Good Manufacturing Practices in FDA- and DEA-inspected facilities.