CAACB Fall Workshop
The Fall 2024 CAACB Workshop will be conducted as a hybrid event, featuring discussions on:
Topic 1: Experience Implementing Guidance of ICH Q5A(R2)
The new ICH Q5A(R2) guidelines, released earlier this year, mark the first update since 1998 and address significant advances in viral safety evaluation for biological products. These guidelines emphasize the inclusion of new molecular methods, like Next-Generation Sequencing (NGS), and considerations for continuous manufacturing and prior knowledge use.
Topic 2: The Continuation of Company Experience with NGS, Including Challenges in Bioinformatics
Next-Generation Sequencing (NGS) offers advanced detection of viral nucleic acids, yet many companies face difficulties in adopting it for GMP use despite regulatory encouragement. This topic explores the benefits and challenges of implementing and validating NGS assays for viral safety, with a focus on bioinformatics.