NEW WEBINAR
Adoption of New Technologies in CGT Manufacturing: Challenges and Drivers
Wednesday 20 May
08:00 AM PT, 11:00 AM ET, 4:00 PM CET
The rapid evolution of cell and gene therapy (CGT) is transforming the biopharmaceutical landscape, bringing unprecedented innovation in manufacturing approaches and therapeutic potential. However, the adoption of advanced analytical and process technologies has not kept pace with scientific progress. Developers must continuously balance speed, robustness, and regulatory compliance while navigating increasingly complex modalities and highly variable products. This creates a critical need for clearer strategies to integrate innovation without compromising quality or approval pathways.
In this expert-led roundtable, moderated by Dr. Natalia Markova, Business Development Director, Refeyn, leaders from across development, regulatory, and manufacturing functions come together to examine the key drivers shaping technology adoption within CGT workflows. The discussion will explore how emerging analytical tools and process innovations can be successfully introduced alongside established methods, and what is required to build confidence among regulators, manufacturers, and other stakeholders.
Panelists will share insights into evolving regulatory expectations, highlighting important distinctions between upstream characterization and GMP release testing, as well as the level of evidence required to support new approaches. The conversation will also consider how increasing flexibility in chemistry, manufacturing, and controls (CMC) frameworks is influencing adoption decisions, enabling innovation while maintaining rigorous standards.
Attendees will gain practical perspectives on modernizing CGT manufacturing strategies, with a focus on managing risk, ensuring scalability, and sustaining regulatory confidence. Key themes will include overcoming barriers to adoption, integrating novel and traditional technologies, and applying lessons learned from past successes and challenges across the industry.