Extractables & Leachables for Pharma Summit 2021

CONFERENCE OVERVIEW

Extractables and leachables (E&L) studies has now become a key component of product launch. Regulatory agencies are very concerned about the interaction between the final drug product and container closure systems, drug delivery devices, as well manufacturing components. Hence, the migration of mobile chemicals from components and ingredients used in drug production and storage demands careful evaluation.

Our dedicated online meeting brings together managers, scientists and toxicologists in the E&L field to share the latest in analytical methods for E&L, regulatory updates and compliance, risk based E&L programs, chemical characterization, toxicological risk assessment, E&L studies validation, E&L assessment in biomanufacturing and processing equipment, E&L data for selection and qualification of single use systems, material selection/screening/qualification, custom approaches for the specific type of product.

Be present at our virtual meeting to equip yourself with new tools and vital knowledge to analyse and test for extractables and leachables in biopharmaceutical development to effectively minimize E&L associated risks and assure patients’ safety and product quality.

WE WILL TALK ABOUT

• E&L programs to balance costs and turnaround time.
• Effective E&L study designs.
• Toxicological assessment for E&L.
• From knowns and known unknowns: managing uncertainties in the risk assessment of leachables & extractables.
• From extractables to leachables – how to deal with complicated formulations.
• Analytical challenges in E&L assessment.
• How to write a toxicological risk assessment to support extractables and/or leachables profiles: a step-by-step process.
• How to create and deploy an extractables/leachables testing program for a multi-modal company/facility.
• Chemical characterization in biocompatibility testing of medical devices.
• Extractables and leachables in biologics – lessons learned and hands-on solutions.
• Predictive modeling in support of chemical safety risk assessments.
• Extractables and leachables analysis using a quadrupole time-of-flight (QTOF) mass spectrometer and swath acquisition.
• Single-use bioreactor material characterisation as critical issue for cho cells performance: new approaches.

WHO IS IT FOR?

CxO, VP, Directors, Heads, Managers of

• Extractables and Leachables/ E&L
• Analytical Chemistry/ Analytical Development/ Analytical Science
• Product Characterisation/ Risk Assessment
• Drug Development/ Drug Substance
• Drug Safety/ Compound Safety/ Toxicology
• Device Development/ Device Engineering/ Container Development
• Good Laboratory Practice (GLP)/ Good Manufacturing Practice (GMP)
• Manufacturing Science & Technology/ Single Use Systems
• Bioprocessing/ Bioproduction
• Regulatory Affairs & Compliance
• Materials Science/ Materials Selection/ Biocompatibility
• Packaging & Labelling
• LC-MS/ Mass Spectrometry

[Agenda] Extractables & Leachables for Pharma Summit 2021

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.

INTERTEK WHITE PAPERS

White Paper | Extractables and Leachables Strategies for Pharmaceutical Production Tubing

White Paper | Extractables and Leachables Strategies for Transdermal Delivery Patch Products

Case Study | Extractables Study of Bioprocessing Single-Use System

White Paper | Extractables and Leachables Strategies for Prefilled Syringes