Using new and existing technologies to improve aseptic processing manufacturing may provide the need and opportunity for new approaches to process control and monitoring.
This is the second in a three-part series exploring the need to achieve improvement in aseptic processing of sterile biopharma products. Part 1 presented the current state and opportunity for improvement using innovative technology. Part 2 discusses changes in strategy that might be needed as a result of technology implementations.
This article is the first in a three-part series exploring the need and means to achieve improvement in aseptic processing of sterile biopharmaceutical products. Part 1 presents the current state and opportunity for improvement using innovative technology. Part 2 further discusses some of the changes in strategy that might be needed for and result from the use and improvement of technology. Part 3 presents the impact of technology changes.
In recent years, we’ve seen a rise in regulatory concern over adequately determining the risk factors that challenge aseptic and sterile products processing. There needs to be a renewed emphasis on assurance and controls, including leveraging the best available technologies and conducting thorough, science-based risk assessments of processes.
Once a process is identified as “risky,” we tend to accept that risk and do little to try to uncover ways to reduce that risk and improve the process.