Extractables and Leachables of Biopharmaceutical Container Closure Systems

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.

Topics covered:

• 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:

Hannah Tims, PhD.
Principal Chemist
Pace Labs

Daniel Abate, PhD.
Principal Chemist
Pace Labs