PDA Webinar: Extractables and Leachables for Parenteral Applications Series

When making parenteral drug products, pharmaceutical companies are faced with the regulatory requirements to further investigate the materials that will be in contact with the drug product either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations; recently, quality issues, i.e. for biopharmaceuticals, have become an additional concern.

This pre-recorded webinar series will look at Extractables and Leachables (E/L) from many different angles:

• Regulatory Requirements and Guidelines
• Materials and Polymer Science
• Mechanisms of Leaching and Material-Drug Product Interaction
• Analytical E/L Methodologies
• E/L Study Design for Different Packaging Systems
• Large Volume Parenterals
• Lyophilization Applications

Several interesting case studies on the above topics will also be presented.

The following sessions will take place in this pre-recorded webinar series:

Week 1

10AUG2021 (09:00 – 11:00 UTC -5)
Session 1: Introduction, Helicopter View, and Setting the Stage
Dennis Jenke

11AUG2021 (09:00 – 11:00 UTC -5)
Session 2: Polymers 101 and Mechanism of Leaching
Piet Christiaens

12AUG2021 (09:00 – 11:00 UTC -5)
Session 3: Analytical and Toxicology 101
Dries Cardoen and Kevin Breesch

Week 2

17AUG2021 (09:00 – 11:00 UTC -5)
Session 4: Extractables and Leachables Do’s and Don’ts
Dries Cardoen

18AUG2021 (09:00 – 11:00 UTC -5)
Session 5: Single Use Systems – Biodisposables and Simulation Studies LVP
Karen Pieters and Dennis Jenke

19AUG2021 (09:00 – 11:00 UTC -5)
Session 6: Small Volume Parenterals – Rubbers, Lyo Applications, Combination Products
Piet Christiaens