This session aims to provide a diverse set of perspectives on quality/regulatory topics as it pertains to late stage/commercial ATMPs (primarily autologous cell therapy). The goal is to bring industry and regulators together to discuss shared challenges and highlight learning opportunities for both as this field evolves. In particular, the presenters will provide a good view of what areas of opportunity exist - focus areas on capacity expansions/needs, aseptic processing challenges, raw material challenges, and inspection aspects are examples of the topics that would be mutually beneficial as well as of great interest to attendees. While technical challenges are at the forefront of this complex manufacturing environment, the regulatory and quality considerations associated with these need to be factored in so that health authority expectations can continue to be met. Further industry-regulator collaboration will aid in this effort.
Senior Director, Manufacturing Science and Technology,