Scaling up: overcoming challenges in ATMP bioprocessing

This activity explores the main challenges involved in scaling up ATMP biomanufacturing processes, with a particular focus on raw materials, equipment and logistical constraints.

This activity presents a case study on the industrialization of in vivo viral vectors, focused on the analysis of a non-conformity in an engineering batch, progressing step by step from its identification to the conclusion of the investigation, including root cause analysis.

This activity explores the main challenges involved in scaling up mRNA vector biomanufacturing processes. Case studies focusing on the in vitro transcription step and on optimizing the size of lipid nanoparticles enable practical application in an industrial context.