The Spring 2025 CAACB Workshop will be conducted as a hybrid event, featuring discussions on:
Adventitious Agent Control in Continuous Manufacturing
This topic covers the challenges and solutions in controlling adventitious agents in continuous manufacturing, focusing on the new ICH Q5A(R2) guidelines. It includes case studies on viral clearance, risk evaluations for unit operations, and the role of technologies like NGS in continuous monitoring, as well as strategies for managing the risk of viral contamination and process disturbances.
Experience with Mycoplasma Contamination and Prevention
This topic focuses on the challenges of mycoplasma contamination in biomanufacturing due to its small size, lack of cell wall, and ability to evade detection. It includes case studies on detection, decontamination strategies, and corrective actions, as well as discussions on new technologies like NGS and their potential to replace traditional methods such as qPCR.