Work Item
ASTM WK92237
New Guide for PAT System Application and Lifecycle Management in Biopharmaceutical Industry
1. Scope
1.1 This standard provides guidelines and considerations for the implementation of Process Analytical Technology (PAT) systems in biopharmaceuticals (biologics, cell and gene therapy, etc.) from an end-to-end lifecycle perspective. The intrinsic differences between biopharmaceuticals (i.e., large molecule) and pharmaceuticals (i.e., small molecule) in terms of raw material, structure complexity, and process characteristics make the existing guidelines for PAT system development, implementation and application in the pharmaceutical industry lacking specific considerations for PAT system applications in the biopharmaceutical industry. 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 includes drug substance and drug product. In this standard, the term biopharmaceuticals and biologics are used interchangeably. The general biologics production process flow shown in Figure 1 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. Figure 1. A general flow diagram for biologics manufacturing process 1.4 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. 1.5 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).Keywords
Process Analytical Technology; biopharmaceuticals; pharmaceuticals; PATRationale
It intends to provide guidelines and considerations for the implementation of Process Analytical Technology (PAT) systems in biopharmaceuticals (biologics, cell and gene therapy, etc.) from an end-to-end lifecycle perspective. Given the intrinsic differences between biopharmaceuticals (i.e., large molecule) and pharmaceuticals (i.e., small molecule), the existing guidelines for PAT lack specific considerations for PAT system applications in the biopharmaceutical industry.
Work Item Status
Date Initiated: 09-10-2024
Technical Contact: zhenqi Shi
Item: 005
Ballot: E55 (24-06)
Status: Negative Votes Need Resolution