4. Automation pyramid levels 0 to 2: What is process automation?
As its name suggests, process automation is a manufacturing strategy that leverages automated equipment and software to replace, improve, or accelerate manual operations.
Because of their small batch sizes, ATMP manufacturers face the challenge of repeating the same unit operations at a much higher frequency than other biologics manufacturers, with far more inputs and outputs in play and a greater demand on manufacturing equipment as a result. This can lead to bottlenecks across the manufacturing lifecycle and hamper manufacturers’ ability to scale or change their process as new opportunities emerge.
Establishing and automating a standard process platform that’s easy to maintain, designed for open connectivity, and flexible enough to evolve as your process changes will solve many of these challenges.
Benefits of process automation:
Recent developments in robotics and other automated technologies are helping ATMP manufacturers achieve process closure where it wasn’t possible before. That means eliminating or reducing both the bioburden risks and the risk of human error inherent in manual, open processes. The result is a stronger compliance strategy.
Real-time batch releases and reduced lab testing
Automation opens the door to accurate in-line data collection via PATs and smart instrumentation, giving you the ability to monitor certain critical quality attributes (CQAs) and critical process parameters (CPPs) in real-time.
If you have a clear understanding of the CQAs and CPPs that define your product and you have the right automation strategy in place, you may be able to register certain deviations and make adjustments before engaging the quality lab—an efficiency that could save you significant time and resources, and that may help you save whole batches that might otherwise have had to be discarded at a great cost to patients in critical need.
Next-level standardization
Every unit operation levies a cost in terms of the programming and validation effort involved. The more you’re able to standardize and automate those unit operations, the lower that effort will be, helping you to pivot between batches or products with more speed, flexibility, and cost control.
Improved scalability and modularity
Many ATMP manufacturers rely on modularity, and they need the ability to scale quickly by adding or moving equipment as their business matures, batch numbers increase, and product pipelines expand. That level of flexibility is much easier to accommodate in a manufacturing environment that’s highly automated.
An early commitment to process automation will pay off long into the future, in part because it positions you to rapidly adopt new technologies as they become available (such as a sensor capable of inline microbiological testing). In a manually-driven process made up of standalone, custom-designed unit operations, this type of opportunistic tech expansion is tricky and can elevate your costs.