1. Scope

Keywords

Rationale

Cellular and gene therapy products present unique particulate control challenges not addressed by existing pharmacopeial standards, which were developed for conventional biologics and small-molecule drugs. These products cannot be terminally filtered, often have small batch sizes and limited sample volumes, and contain inherent biological particulates that complicate detection and classification. No current standard provides a risk-based framework specifically tailored to the particulate control needs of this product class. This standard will be used by manufacturers of cellular therapeutic products to establish and implement particulate control strategies across the product lifecycle, from development through commercial manufacturing. It provides guidance on risk assessment, detection and characterization methods, supplier qualification, investigation of particulate findings, and the establishment of internal alert and action limits. It also introduces the Particulate Characterization Library as a structured tool for trending, investigation support, and institutional knowledge management. Primary users include quality, manufacturing, and analytical scientists at cell and gene therapy companies, contract development and manufacturing organizations (CDMOs), and suppliers of ancillary materials and single-use systems. Regulatory agencies, industry working groups, and standard-setting bodies will also reference this document when developing or evaluating particulate control expectations for advanced therapy medicinal products.