Advanced Therapy Medicinal Products (ATMPs) define a broad category of complex and innovative biological products which encompasses tissue and cell-based products and gene therapy products. These revolutionary medicines offer groundbreaking new opportunities, addressing unmet medical needs for rare and complex diseases.
This field has grown at fast pace during the last years, nevertheless, manufacturers still need to face several challenges. Among these, high costs and resource demand, pose significant hurdles especially in the transition from bench to bedside, when the demand for validated assay and GMP requirements must be fulfilled.
The aim of the webinar is to provide an overview of platform methods and how to develop analytical platforms as a way to address sustainability and affordability of ATMPs. Real examples, focusing on some of the platform method developed at Eurofins BioPharma Product Testing Italy, will be showcased.