The FDA defined the process analytical technologies (“PAT”) framework in 2004 to optimize the control and monitoring of bioprocessing technologies. The goal is to produce a predefined quality product at the end of the process. (These technologies are subject to 21 CFR 211 compliance guidelines.)
PAT’s key objective is to identify and manage process variability. A process should accurately and reliably predict quality attributes given materials, process parameters, manufacturing, environmental, and other conditions. This requires analytical tools that enable real-time monitoring, as opposed to retrospective analytical tools that only demonstrate past controls.
PAT tools include multivariate tools, data acquisition and analysis, process analyzers, among other tools. Manufacturers use multivariate tools, data acquisition, and analysis to optimize formulations and processes. They also employ process analyzers as sensing technologies in-line, on-line, and at-line to observe process or product attributes.
ASTM has developed several standards for process analyzers currently used by the industry. Process analyzers measure critical attributes and ensure consistent quality of outputs.
Biopharma customers use continuous improvement and knowledge management tools to assist with product life cycle management and to help justify proposals for post-approval changes.
PAT has demonstrated significant benefits for biologics manufacturers. It allows for real-time monitoring, enabling immediate detection and addressing of fluctuations. This leads to greater control over manufacturing, yielding higher quality products. PAT also reduces the burden of validating systems. By focusing on the process itself, PAT tools ensure that the manufacturing process is well understood. This eliminates the need for retrospective analytical tools to demonstrate control. PAT can optimize formulations and workflows, impacting cost savings and efficiency.
Despite these benefits, there are also some challenges associated with implementing PAT. Investing in new technologies, such as sensors, controllers, and software automation tools, can be a major financial hurdle, especially for smaller companies. Additionally, there is a need for specialized expertise in the use and interpretation of PAT data, which can be difficult to obtain.
That said, the benefits of PAT are clear, as evidenced by the framework’s widespread adoption within the biopharma industry.
What is the Process Analytical Technologies (“PAT”) Framework?
