The WCBP Symposium series has established a reputation as the most highly-regarded annual conference addressing the role of current and emerging CMC analytical technology among evolving US and international regulatory perspectives. Biopharmaceutical manufacturers and academics along with regulatory agency representatives have used the WCBP Symposium to describe and discuss successful approaches in plenary sessions and informal workshop discussions. The interactive format of the Symposium has proven to be an effective means of benchmarking strategies and clarifying expectations among the regulatory and technical experts.