Pathogen safety is a crucial but sometimes overlooked aspect of the development of advanced therapy medicinal products
Over the past few decades, many lessons have been learnt by the wider biological medicinal product community when it comes to preventing transmission of viral infections. The World Federation of Haemophilia’s mantra of ‘never again’ is still very valid and relevant for the industry and is, in Dr Thomas R. Kreil’s own words, a good reason for getting to work in the morning.
We spoke to Dr Kreil recently to explore the importance and advancements of pathogen safety for advanced therapy medicinal products (ATMPs), as well as what the community can learn from earlier experiences with plasma and recombinant protein medicinal products. Even beyond pathogen safety, these lessons are never more important than when applied to therapies that have an extremely restricted supply chain. For example, in the case of autologous therapies, where one dose may be a patient’s only chance for treatment, it cannot possibly be compromised by any pathogen safety concerns.
Dr Kreil is not only a leading world expert in pathogen safety but also a passionate advocate of patient safety. We put to him the questions you need to know answers to, but may not have the opportunity to ask.
In part one of this interview Dr Kreil provides his expert opinion on:
- Lessons and methods learnt from the biologics industry: the safety tripod
- Risk mitigation when you have a single manufacturing source
- The regulatory landscape