Researchers, scientists and engineers encounter plenty of obstacles on the journey to bringing a new therapies or medicines to the market. Understanding key product characterization details such as stability, primary packaging and determining optimal process conditions for manufacturing are necessary elements of the drug development process. Having the right development tools available minimizes obstacles to gaining this product and process knowledge. To aid the drug development process AST’s GENiSYS® and semi-automated systems allow scientists and engineers to characterize their drug product and develop data driven manufacturing processes in more meaningful and scalable ways.
GENiSYS® was specifically designed with drug development in mind. This innovative, feature rich platform provides all of the automated manufacturing processes necessary to aseptically fill and close vials, syringes and cartridges on an extremely compact machine. The system’s design replicates the conventional filling and closing actions for vials, syringes and cartridges. By using these conventional filling and closing activities the developed production processes can be scaled to higher volume production lines for clinical or commercial manufacturing.
AST’s Syringe Vacuum Stoppering machine allows engineers and scientist to develop and characterize the syringe closing process using a simple benchtop machine. The machine’s intelligent servo control system tightly controls the recipe driven process to ensure a repeatable and consistent syringe closing. The multi-stage vacuum process is one of the most versatile processes for closing syringes, allows for processing glass and plastic syringes and can provide a syringe that is bubble-free.
In order to facilitate a streamlined technology transfer process, GENiSYS® and the Syringe Vacuum Stoppering Machine can be provided with a 21 CFR Part 11 compliant, batch reporting system with a data repository. The process data generated and recorded during batch production can be exported to an Excel readable file that can be analyzed to gain further process insight to optimize the manufacturing process. By having abundant process information at your fingertips both these systems are ideal tools that can be leveraged to improve the drug development process within any pharmaceutical or biotechnology organization.