1.1 This standard provides guidelines and considerations for implementation of Process Analytical Technology (PAT) systems in the biopharmaceutical industry from an end-to-end lifecycle perspective.
1.2 The scope of the PAT systems in this guide aligns with the definitions in the FDA and EMA guidelines: PAT is a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality. It is important to note that the term ‘analytical in PAT’ is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner.
1.3 The scope of PAT system applications in biopharmaceuticals (biologics) production include drug substance and drug product. The generic biologics production process flow represents the commonly used biologics processes and can also be adapted for cell and gene therapy (CGT) processes. The CGT processes may have different unit operations.
1.4 The considerations and guidelines in this standard for PAT system applications in biologics manufacturing (e.g., therapeutic proteins) can be applied to CGT manufacturing.
1.5 The considerations and guidelines in this standard may be applied regardless of the complexity of the PAT system applications and could be applied to batch or continuous processing.
1.6 This guide supports the principles of the ASTM standard guides (Section 2) and extends these principles to the PAT system applications in biologics production (e.g., this guide can be used in conjunction with ASTM E2629 if the PAT system is a part of a process control system).
Process Analytical Technology, PAT,; biopharmaceuticals; biologics
no existing standards
The title and scope are in draft form and are under development within this