Extractables and Leachables of Biopharmaceutical Container Closure Systems
Learn how to navigate the regulatory requirements for extractables and leachables testing for new biologic drug products. Review the essential steps to for study design, extraction, analysis, and reporting of extractables and leachables data in this webcast. Live: Thursday, Sept. 24, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until Sept. 24, 2021
Register free: https://www.pharmtech.com/pt_w/container_closure
Event Overview:
As biopharmaceutical drug product development continues to grow, so do new regulations on packaging and container closure components associated with delivery of the drug product to the patient. This webcast will present a brief introduction to extractables and leachables (E&L), followed by a discussion of relevant United States Pharmacopeia and ISO guidelines and practical considerations when planning an extractables and leachables project. A case study demonstrating a typical extractables and leachables project, including the design, extraction, analysis, and reporting of extractables and leachables data for single-use IV bags used for bioprocessing purposes will be presented. Learn best practices for an extractables and leachables program and how to analyzing materials for biologics drug projects.
Key Learning Objectives:
- Review results and analysis of an E&L case study of biopharmaceutical single-use bag systems
- Gain an overview of the process, procedures, and approaches for biopharma E&L studies
- Understand analytical capabilities and expertise needed to conduct effective studies
Speakers: Daniel Abate, Ph.D., Principal Chemist, Pace Labs
Hannah Tims, PhD, Principal Chemist, Pace Labs
Time and Date: Thursday, Sept. 24, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
On demand available after final airing until Sept. 24, 2021
Sponsor: Pace Analytical
Register free: https://www.pharmtech.com/pt_w/container_closure
