Dr. Samuel Kikandi, PhD
Deputy Director – Principal Engineer
Dr. Samuel Kikandi holds a PhD in Chemistry from the State University of New York at Binghamton, NY, specializing in electrochemistry and degradation of endocrine disrupting chemicals (EDCs). Upon entering the pharmaceutical industry, he identified the critical link between EDCs and extractables/leachables (E/L) in single-use systems. With 15 years of pharmaceutical experience, Dr. Kikandi serves as Deputy Director-Principal Engineer at Sanofi Inc., leading Material Science and E/L programs. His expertise is widely sought across Sanofi’s global business units and by external organizations for consultation on complex E&L challenges. Dr. Kikandi enjoys active contributions to industry advancement through ELSIE and BioPhorum expert teams, addressing critical topics including USP665, USP661.1, 661.2 standards and more.
DAY 2: March 6th, 2026
SESSION: Swift Extractables and Leachables Qualification of Pharmaceutical Product
Contact Single Use Systems
Summary: This presentation addresses critical industry challenges in conducting swift Extractables and Leachables (E&L) Qualification of Pharmaceutical Product Contact Single Use Systems (SUS) in pharmaceutical manufacturing. As SUS adoption accelerates, the session demonstrates how manufacturers and end users can achieve rapid qualifications while maintaining rigorous safety standards and full regulatory compliance with FDA, EMA, and other global health authorities. The presentation provides practical implementation strategies centered on industry-standard risk assessment models, particularly navigating key regulatory chapters USP <665>, ICH Q3E, and ISO standards guidelines while tapping related BPOG protocol strategies. By emphasizing a seamless qualification process that balances speed with scientific rigor, attendees will gain tools to optimize E&L workflows, reduce time-to-market, and maintain the highest standards of patient safety and product quality. The content is particularly relevant for quality assurance professionals, regulatory affairs specialists, and manufacturing engineers and scientists working with single-use systems in pharmaceutical and biopharmaceutical production.
