Director, Scientific Affairs West Pharmaceutical Services, Inc. Exton, Pennsylvania
Early Phase Control Strategies for Extractables and Leachables: Extractables and leachables are an essential part of qualifying materials used to manufacture, store and deliver drug and biologic products. The regulatory requirements for extractables and leachables will be based on the type of therapeutic product with its delivery system and the intended use. Information on the delivery system, including its individual components and materials of construction is necessary and can be evaluated throughout the drug/biologic development cycle. Even when changes are inevitable during pre-formulation, formulation and dose finding studies, risks can be identified and mitigated based on knowledge acquired in early development phases. In order to implement a Quality by Design (QbD) process, the target product profile (TPP) must be defined so that holistic design inputs can be determined and investigated to confirm quality and safety of final product. Extractables from drug product container closure and deliver systems could affect final product and should be assessed early to identify potential migration into the drug product and impact to patient safety. A risk and science-based approach can be applied to identify and mitigate potential leachables through evaluation and correlation of extractable data. This presentation will provide background on the evolving regulatory and therapeutic landscape to allow for proper planning of extractables and leachables studies, with considerations for drug- device combination products. An analytical framework for understanding risks to drug/biologic quality and patient safety will be discussed with respect to acquiring and leveraging extractables data with subsequent leachable studies. The end goal is to progressively advance knowledge from early phase development for clinical readiness and prepare for leachables to be validated in time for late phase registration batches.
Discuss the Evolving Regulatory and Therapeutic Landscape
Construct an Analytical Framework for Extractables and Leachables
Examine Leachables and Extractables Approaches Relative to Drug- Device Combination Products
Manage Extractable and Leachables Data and Application of Analytical Evaluation Thresholds