GMP-like Drug Product Testbed Laboratory

Impact on the development of the principal discipline(s) of the project. A fully functional aseptic filling line and visual inspection robot were designed, installed, and commissioned. The semi-automatic Bausch and Strobel Variosys line supports the filling of three container types—vials, cartridges, and syringes—at a rate of 60 containers per minute. To enable future GMP-compliant operations, the system includes a SKAN Isolator capable of Vaporized Hydrogen Peroxide (VHP) sterilization.

Impact on other disciplines. This project provided opportunities for the NIIMBL researchers to fill non-commercial products in containers for further research. The filling line can support the GMP test bed continuous processing effort. In addition, the line can be used by partnering pharmaceutical companies to train their technicians, do drug product development, and/or present to end users to better understand the physical size, features, documentation and capabilities of the equipment firsthand.

Impact on teaching and educational experiences: Establishing drug product capabilities presents numerous educational opportunities. The filling line is intended to be used for workforce training of drug product filling and inspection by technicians. In addition, the filling lien may be used in biopharmaceutical curricula to educate or train technicians of drug product equipment and operations.

Impact on society beyond science and technology. The need for a stronger pharmaceutical-trained workforce became apparent during the COVID-19 pandemic. Providing opportunities for companies to further research drug product development and train their current or future staff without impacting their production lines could have significant societal benefits.