GMP Principles in iPS Cell Line Development: A Key Foundation for Advancing Therapeutic Applications

Introduction

The manufacture of Advanced Therapy Medicinal Products (ATMPs) requires the generation of high-quality starting materials, specifically cell lines, to ensure the safety and efficacy of the final product. One of the key advantages of iPSC allogeneic cell therapies is the creation of a master cell bank for the lifetime of the commercial product. The creation of this cell bank is performed once and relies on lengthy small-scale reprogramming and gene editing processes. The GMP principles, as defined by the European Medicines Agency (EMA) in the guideline EMA/246400/2021, provide a framework for manufacturing starting materials from biological origin, particularly for products involving gene transfer. These guidelines form the foundation of the Quality Management System (QMS) implemented by Cellistic for Cell Line Development,aligning with the International Council for Harmonisation (ICH) Q7 guideline regarding starting materials for biological manufacturing.