To address these complexities, ISPE and its ATMP Community of Practice have developed a comprehensive ISPE Guide: ATMPs – Equipment Design and Qualification for Cellular Products.
Why This Guide Matters
Cell therapies—both autologous (patient-derived) and allogeneic (donor- or cell-line-derived)—require highly specialized equipment to ensure safety, consistency, and compliance with GMP standards. “This is the first guide of its kind to outline how to select, design, and qualify cell therapy equipment and ATMP equipment in general,” said Guide Co-Lead Charles Hefferman, Director of Advanced Therapies and Biologics, PM Group.
This Guide provides practical recommendations and expert insights into selecting, qualifying, and using equipment for these processes, including in-process testing and contamination control. Equipment qualification is a regulatory requirement for commercial therapies and is critical for ensuring consistency in biopharmaceuticals manufacturing, including cell and gene therapies. It ensures that equipment used in producing batches operates consistently and reliably, yielding products that meet all quality standards.
“Having a guide that addresses the equipment specifically for cellular therapy will be beneficial for readers,” added Guide Co-Lead, Anthony Thatcher, Senior Director, Manufacturing Operations, Sumitomo Pharma America Inc.
“Cellular therapy products have unique challenges. One challenge is that the equipment used is usually built for laboratory scale and not commercial scale. The key is to start early in determining the required equipment and how to design and qualify, which includes validation of the process for data collection from the manufacturing and laboratory equipment. This early thought process also helps with defining the GMP and regulatory framework for product licensing and creating a road map for a successful therapy launch,” said Hefferman.
Key Highlights
- Focus on GMP manufacturing: Covers equipment for gene-modified and unmodified cell products
- Automation and digital tools: Identifies opportunities to reduce manual steps and improve process control
- Real-world applications: Offers best practices and technical details for both autologous and allogeneic workflows
- Alignment with global standards: US Food and Drug Administration, European Medicines Agency, Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme frameworks, and ISPE Baseline® Guides
Who Should Read It?
- Manufacturers who can gain a roadmap for adopting new equipment for one or more stages of their process
- Equipment developers and suppliers who can gain an understanding of the unique challenges and unmet needs in cell therapy production
This Guide outlines the applicability of equipment in manufacturing environments, defines functional ranges, and highlights opportunities to reduce or eliminate manual steps through the implementation of automation and digital tools.
“When cell therapy products first emerged, there was not enou-gh demand for the specialized equipment that would lead to vendor support and automation,” Thatcher and Hefferman said. “Now, as new cell therapies with larger indications have been approved in the last decade, the demand is there and more automated systems are coming available; however, the level of adoption is still slow.”
This Guide is more than a reference—it’s a call to action for innovation. By embracing closed, automated, and scalable solutions, the industry can deliver cost-effective therapies and better outcomes for patients worldwide.
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