Advanced therapies are the most innovative peak of biotech drugs and they are revolutionizing the manufacturing by laying the foundations for new production methods in the pharmaceutical sector and opening up a world of new and interesting professions for young people. We begin our journey by welcoming the direct experience of professionals dedicated to cell manufacturing for gene and cell therapies and also exploring the Quality Systems that oversee such processes.
WEBINAR 1 – May 19 at 2 pm
A JOURNEY THROUGH CELL FACTORIES FOR GENE AND CELL THERAPY
The manufacturing of cells for Advanced Therapies occurs in sites which are very different from the traditional pharmaceutical plants. These are the “cell factories”, manufacturing boutiques authorized by regulatory authorities for GMP productions, which use innovative systems and a new manufacturing concept to face the complexity of such drugs.
WEBINAR 2 –June 9 at 2 pm
THE QUALITY SYSTEM AS BACKBONE OF QUALITY OPERATIONS
Cells for Advanced therapy cannot be terminally sterilized and they are manufactured in aseptic conditions. In order to ensure the infusion of sterile products in patients, an excellent Quality System capable of overseeing all the manufacturing phases until the release of the finished product is critical. The leading principle of such drugs is the following “the quality of the product is the quality of the process”.
In collaboration with:
– Biology and Biotecnology Department “L. Spallanzani” Universita‘ Di Pavia
– Molecular Biotechnology Center (MBC) – University of Turin
– Italian Biotecnology Association (ABI)
– MEDIA PARTNER web magazine MakingLife