ISPE Guide: Advanced Therapy Medicinal Products - Validation Methods and Controls Throughout the Cell and Gene Therapy Product Lifecycle

Published: September 2025
Pages: 102

• Table of Contents
• Special Pricing for Emerging Economies

Advanced Therapy Medicinal Products (ATMPs) represent a revolutionary frontier in medicine, offering life-changing treatments for conditions previously deemed incurable. However, the intricate nature of these therapies, from their unique raw materials to complex manufacturing and logistics, presents significant challenges and inherent risks.

This Guide offers practical guidance on applying validation methods and control throughout the cell and gene therapy product lifecycle. It outlines risk-based strategies tailored to the unique nature of these products, addressing key areas such as analytical methods, equipment, processes, cleaning, and supply chain. It also includes essential insights into regulatory expectations and phase-appropriate considerations that support timely development and commercialization. 

Developed for professionals in cell and gene therapy, this ISPE Guide: ATMPs – Validation Methods and Controls Throughout the Cell and Gene Therapy Product Lifecycle provides actionable insights to help navigate the complex ATMP landscape. It promotes flexible, science-driven development approaches that support informed decision-making and help accelerate patient access to these transformative therapies.

Guide Core Team

Biana Torres

Senior Director, Quality Assurance

Encoded Therapeutics

Jean François Duliere

Regulatory Advisor

ISPE

Maria Amaya, PhD

Lead External Advocacy North America (Quality Policy)

Genentech, A Member of the Roche Group

Jose Caraballo-Oramas

Vice President, Quality

Kite, a Gilead Company

Pinar Cicalese

Senior Director, Global Patient Supply Operations

Immatics

Ryan Murray

Senior Consultant

Valsource Inc

Nessiem Samuel

Partner, VP of Compliance & Validation

GxP Impact Consulting LLC.

Peter Walters

Fellow, Advanced Therapies

CRB

For the full list of contributors to this Guide see Guidance Document Teams