Biologics introduce unique challenges that can complicate extractables and leachables (E&L) study design, analytical testing, risk assessment, and regulatory submissions. At the same time, the regulatory landscape is evolving, with new guidance documents such as the draft ICH Q3E guideline and emerging USP chapters shaping industry expectations for lifecycle-based E&L assessments. Recent FDA Complete Response Letters (CRLs) provide valuable insight into common E&L deficiencies and evolving regulatory priorities. In this webinar, we will explore the factors that make E&L studies particularly challenging for biologics and examine real FDA CRLs to uncover practical lessons that can help sponsors strengthen their E&L strategies, reduce regulatory risk, and support successful submissions. What You Will Learn The factors that make E&L studies more complex for biologics Lessons from real FDA CRLs to help strengthen your E&L strategy What to look for in an E&L testing partner
