Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective

Andy Bailey, CEO / Operations Director, ViruSure GmbH

Advanced therapy medicinal products (ATMPs) are medical products for human use, often used in regenerative medicine. They include gene therapy, somatic cell therapy, tissue engineered, and regenerative medicine products. In the EU, ATMPs are regulated under a consolidated framework for advanced therapies as pharmaceutical products.¹ Within the EU, control of safety, consistency, reproducibility, and uniformity are key aspects of compliance for ATMPs. Annex 2 of the EU guidelines for medicinal products for human veterinary use has been updated to include GMP regulations for ATMPs. In the U.S., cellular and gene therapy products are regulated by the Center for Biologics Evaluation and Research.² Yet, in all regulated countries, it is clear that if animal or human cells are being used to develop an ATMP, there must be measures in place to ensure minimum risk when it comes to virus contamination.

Companies in the commercial sector with experience developing biopharmaceuticals understand these virus safety issues and have experience preventing them. However, those in the non-commercial sector without that background, such as universities, medical centers, and government, where many of these products are being developed, often do not have the in-depth experience when it comes to GMP compliance.³ And because doctors face situations where they need to make real-time decisions during the preparation of materials for ATMPs, there is an increased risk of viral contamination in these settings. For these reasons, it is important to understand the contamination risks and the solutions available to control them.