Adoption of new technologies in CGT manufacturing: challenges and drivers
Presenters:
The rapid evolution of cell and gene therapy (CGT) is unlocking unprecedented innovation in manufacturing. However, the adoption of new analytical and process technologies continues to lag behind – creating a critical gap between innovation and implementation.
As developers navigate increasingly complex modalities and heterogeneous products, balancing speed, robustness, and regulatory compliance remains a central challenge.
In this expert-led roundtable, industry leaders from iON BIO Enterprises LLC, Pharmaron, UK, Coriolis Pharma, United States Pharmacopeia and Dark Horse Consulting Group come together to explore what is driving – and delaying – the adoption of new technologies in CGT workflows. Moderated by Dr. Natalia Markova (Refeyn) the discussion offers valuable perspectives on how to integrate emerging tools alongside established methods while building confidence across stakeholders.
What You’ll Learn
- The key drivers and barriers to adopting new technologies in CGT manufacturing
- How to effectively bridge novel analytical tools with established methods
- Insights into regulatory expectations – from upstream characterization through to GMP release testing
- The level of evidence required to support implementation of new technologies
- How evolving flexibility in CMC (Chemistry, Manufacturing, and Controls) frameworks is shaping adoption
- Practical considerations for innovation, scalability, and risk management