Extractable and Leachable Analysis: Impact of E/L in Biologics Manufacturing and Processing

Biologics manufacturing processes have the potential of multiple sources of process-derived impurities, including those from host organisms, process additives and impurities derived from contact surfaces of process equipment, in particular the materials of single use disposables. These impurities may pose potential risk to safety and efficacy of biologics and controlling their level is regulatory requirements. Typically, these impurities are present in trace levels in final product and their identification and quantification can be challenging.

Key Learning Objectives:

• Discuss the Impact of Reactive Leachables have on Biotherapeutics
• (BPOG) protocols will impact E/L data required for submissions
• Discover how impurities in excipients in Drug Formulations can impact long term stability.

Presenter: David A. Weil, PhD (Senior Applications Scientist and Extractable Leachable Analysis Expert, Agilent Technologies, Inc.)

Dr. David A Weil, is a senior application scientist working for Agilent technologies since 2004, located in Wood Dale, IL. David Is married to his amazing wife Naomi and has three older sons.

David’s research is focused on the application of high resolution mass spectrometry coupled with multidimensional separations techniques (GC, LC, and 2DLC, SFC, Ion Mobility) and advanced data mining software tools for multi-omics applications, in particular untargeted metabolomics linked back to changes in biochemical pathways. David is also the global technical leader for Agilent’s Extractable and Leachable analysis project, having developed an accurate mass database and MS/MS library for common E/L compounds. He is active in many collaborations with experts in the Ion Mobility Field (Erin Baker, PNL; Nicole Reisdorph, University of Colorado School of Pharmacy; John McLean, Vanderbilt) and in the E/L field (e.g. Eli Lilly, BD, West Pharma, 3M, Jordi Labs, GE Healthcare, Eurofins, PPD) investigating how new technologies, software and workflows can advance the E/L. Prior to joining Agilent, Dr. Weil was the group leader of the 3M’s Corporate Research Analytical mass spectrometry group (1990-2004) responsible for characterization of extractable/leachable impurities present from a wide variety of drug delivery products including Meter Dose Inhalers, Transdermal Patches, Injectable products and Nasal/oral Sprays packaging

David received his Ph.D. from the University of Minnesota (1984) and Post Doc with Professor Charles Wilkins developing the precursor to MALDI.