Good Practice Guide: ATMPs – Equipment Design & Qualification for Cellular Products

Published: October 2025
Pages: 122

• Table of Contents
• Special Pricing for Emerging Economies

The rapid expansion of cellular therapies has created a pressing need for practical guidance on selecting, designing, and qualifying the manufacturing process for cellular products and in-process testing equipment. Unlike traditional biopharmaceuticals, cellular products pose distinct challenges in aseptic processing, automation, scalability, and technology selection, and scalability.

This Guide addresses these challenges by offering expert analysis, actionable recommendations, and real-world insights into current and emerging technologies. It focuses on equipment used in the GMP manufacture of autologous and allogeneic therapies, including gene-modified and unmodified cell products. Engineered tissues, in vivo gene therapies, and exosome products are not covered due to their unique requirements.

The Guide defines equipment applicability, functional ranges, and opportunities to reduce manual steps through automation and digital tools. It presents broad best practices on better understood topics, with detailed technical guidance on specific equipment types.

Aligned with international regulatory frameworks and industry guidance—including FDA, EMA, PIC/S, and ISPE Baseline® Guides—it supports manufacturers evaluating new equipment and vendors developing solutions for the cell therapy sector.

Developed by ISPE’s ATMP Community of Practice, this Guide aims to advance industry practices and foster innovation in closed, automated, scalable, and cost-effective cell therapy manufacturing systems.

A list of regulatory and industry guidance references for ATMPs is included in the E-Reader (under Materials/Supplements) as a downloadable Microsoft® Word® file to purchasers of the Guide. See the FAQ for access instructions.

The first of its kind, this reference list provides a comprehensive index of regulatory, international organizations, and industry guidance covering the ATMPs in clinical, GMP, and hospital environments.

Guide Core Team

Charles Heffernan

Director of Advanced Therapies and Biologics

PM Group

Anthony Thatcher

Senior Director Manufacturing Operations

Sumitomo Pharma America, Inc.

Erich Bozenhardt

Associate Director Process Engineering, Regenerative Medicine

United Therapeutics

Jose Caraballo

VP Quality Systems, Compliance, and Quality Engineering

Kite Pharma, Inc.

Stephen Judd

European Director of Process Technology

Arcadis

Judith Koliwer, PhD

Senior Industry Advisor and Principal Consultant for Advanced Therapies

Koerber Pharma Software Inc

Zoe Reilly

Sr Technical Expert - Sterility Assurance

Skan US

George Todorov

Sr. Process Specialist, GST

IPS - Integrated Project Services LLC

Avril Vermunt

VP, Biologics CMC Development, Global Manufacturing

Telix Pharma

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