ATMP Comparability and Characterization Strategy in 2023 – Playbook 8 ATMP Comparability and Characterization Strategy in 2023 – Playbook 8 Advanced Therapy Medicinal Products (ATMPs) represent a unique class of innovative therapeutics, encompassing gene therapies, somatic cell therapies, and tissue-engineered products. Given the complex nature of ATMPs, the regulatory environment requires comprehensive comparability and characterization strategies to ensure their safety, efficacy, and quality. This article serves as a structured step-by-step tutorial guide specifically targeting regulatory affairs professionals engaged in developing ATMPs. We will explore the fundamental aspects of comparability protocols, critical quality attributes (CQAs), potency assays, and reference standards. Step…