ALC - BioAgil

Strategies to overcome bioanalytical challenges in Cell & Gene Therapies development

With advancements in molecular and cellular engineering techniques, the number of cell and gene therapy (C&GTs) drug development programs has increased significantly in the last 5 years. Following the first gene therapy gaining FDA approval in 2017, the biopharma industry quickly expanded within the C&GT space, leading to a further 21 C&GTs being approved by 2022. As drug developers begin to realize the potential of these new modalities, it is no surprise that the number of C&GT approvals is predicted to rise, with over 1,000 C&GT clinical trials currently ongoing.¹ The FDA has predicted it will be approving between 10 and 20 C&GT products per year by 2025.¹