Cell and gene therapies are critical emerging treatment modalities with the potential to tackle and cure conditions from life-limiting genetic disorders to cancers. The GCT track will enable to exchange scientific ideas and dialogue with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products.
Meanwhile at the Aseptic Processing Technology track we will overview regulatory updates and their implementation, main challenges and overcome consideration, new technologies and innovations to avoid mistakes and ensure safe highly potent aseptic production for both sides – manufacturer and patient. This track (APT) will help you improve your aseptic processes and address contamination control issues that you may encounter.
On the APT track you will learn about environmental monitoring systems, facility cleaning and disinfectant qualification, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation, and regulatory requirements. Further discussions at the GCT Track we will focussing on vector improvement for both ex vivo and in vivo approaches, dedicated sessions on CMC strategy, analytical development and qualification, product-related impurities and their link to quality, bioassays, comparability, stability, formulation, and the emergence of non-viral gene therapies.
I would like to express my sincere thanks to all the dedicated colleagues who are working very hard to ensure the success of the GENAP Summit. I wish the event a great success, and all guests and participants a most rewarding and enjoyable time in Milan. Thank you.