European Pharmacopoeia Commision (EPC) introduces framework for cell-based preparations – Quality Assistance, your strategic analytical guide

In March 2025, the European Pharmacopoeia Commision (EPC) announced the adoption of the new general chapter 5.32 of the European Pharmacopoeia (Ph. Eur.), titled "Cell-based preparations for human use". This new chapter provides a scientific and technical foundation for the quality assessment of cell-based therapeutic products – a significant regulatory milestone for developers of these innovative and complex therapies.

At Quality Assistance, we welcome this advancement and reaffirm our role as a strategic analytical partner, offering expert guidance and tailored support throughout the development of cell-based medicinal products.

“Quality is critical to the success of cell-based therapeutic products. For over a decade, Quality Assistance has been developing expertise in this class of both innovative and challenging products, offering a wide portfolio of technical solutions and competencies.” – Pedro Alves, Scientific Manager Cells & ATMPs

A trusted partner for your cell-based product development

With over 14 years of experience supporting the development of Advanced Therapy Medicinal Products (ATMPs), Quality Assistance offers a comprehensive analytical platform designed to meet the latest Ph. Eur. expectations:

• Safety, Identity, purity, and potency testing of cell-based products
• Detection of impurities and contaminants (residual DNA, endotoxins, microbial contamination)
• Method validation in line with ICH Q2(R2)
• Stability studies

Beyond technical capabilities, we provide our clients with scientific and regulatory guidance tailored to the unique challenges of each product. We build reliable and collaborative relationships, enabling faster, safer, and more compliant product development.

Understanding chapter 5.32

Scheduled for publication in October 2025 (12.2 edition of the Ph. Eur.) and entry into force on 01 April 2026, chapter 5.32 introduces a comprehensive framework for the production and quality control of cell-based preparations, while offering the flexibility required to address the rapidly evolving nature of the field. While not legally binding, the chapter provides an extensive set of general requirements common to all cell-based preparations, together with four detailed sections outlining specific requirements for human haematopoietic stem cells, human chondrocytes, human limbal stem cells, and human mesenchymal stromal cells.

Developing a cell or gene therapy?

Work with a partner who not only delivers analytical results, but also guides your strategy – from early development to regulatory submission.

Contact our experts for a scientific and strategic discussion: