Associate Principal Scientist Veranova Westford, Massachusetts
Extractables and leachables (E&L) testing is a cornerstone of pharmaceutical and biopharmaceutical development, ensuring that materials used in manufacturing, packaging, and delivery systems do not compromise product quality or more importantly patient safety. This session, “Extractables and Leachables: Ensuring Safety Through Science and Strategy,” offers an in-depth examination of contemporary E&L strategies that align with evolving global regulatory expectations and scientific best practices.
We will explore the principles of risk-based E&L evaluations, from controlled extraction studies to toxicological risk assessment, emphasizing the criticality of materials selection, method development, and compound identification. The session will also cover threshold concepts such as the Analytical Evaluation Threshold (AET) and Safety Concern Threshold (SCT), along with the application of the Threshold of Toxicological Concern (TTC) in regulatory submissions.
Attendees will gain actionable insights on how to:
Design robust E&L studies based on product risk and intended use.
Navigate regulatory guidance from agencies like the FDA, EMA, USP, and ISO.
Apply advanced analytical techniques to detect and identify leachables.
Translate analytical findings into meaningful toxicological risk assessments.
Whether you are developing parenterals, inhalation products, or combination devices, this session will provide the scientific rationale and strategic framework to guide successful E&L evaluations and ensure product quality and patient safety from development through commercialization.
Learning Objectives:
Upon completion, participants will be able to describe the role of extractables and leachables (E&L) testing in safeguarding patient safety and product quality throughout the drug development lifecycle.
Upon completion, participants will be able to design risk-based E&L studies tailored to the specific dosage form, route of administration, and material composition.
Upon completion, participants will be able to identify and apply key regulatory concepts such as Analytical Evaluation Threshold (AET), Safety Concern Threshold (SCT), and Threshold of Toxicological Concern (TTC).
Upon completion, participants will be able to demonstrate familiarity with advanced analytical techniques (e.g., LC-MS, GC-MS, ICP-MS) for detecting and characterizing extractables and leachables.
Upon completion, participants will be able to integrate analytical data with toxicological risk assessments to support regulatory submissions and ensure patient-safe product release.
