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2020 E&L Poster Session

The Poster Session at Extractables and Leachables USA gives the opportunity for industry and academic experts to share their technical research, testing results, and latest case studies with an audience of E&L professionals from across the supply chain.

The posters are a prominent part of the exhibition hall to ensure that delegates have plenty of opportunity to visit. The posters are on display throughout the event, with a dedicated Poster Session wherein we ask authors to stand by their posters to allow attendees to answer questions and give comments on the information presented.

If you're interested in displaying your brand in the poster sessions, contact Shannon Siegferth by email at SSiegferth@smithers.com, or by phone at +1 (330) 762-7441 x1156.


Companies Presenting Posters

2020 Poster Sessions Agenda

  1. Efficient Management of Extractable & Leachable Data in Process Development

    Joe DiMartino | Luminata Solution Manager of ACD/Labs

    Analytical and numerical data collected and compiled for Extractable and Leachable (E&L) studies is often scattered among a variety of systems including email, Microsoft applications (e.g. Excel) and electronic notebooks, to name a few. While scientists have developed practices and processes to compile E&L data to help make decisions, it remains a tedious manual process where simple questions such as “what extractables have been found from material x?” are not easy to answer. In this poster, we introduce Luminata®—a CMC decision support application that helps project teams address the challenge of effective data management across product development. Luminata enables scientists investigating drug products and enclosure systems to create E&L study maps from data processed in the software of their choice. E&L study data may be assembled from various systems, connecting analytical data with study conditions and observations, in a single software for easy sharing, streamlined access, and effective decision-support. The ability to store E&L study data in one searchable location facilitates risk-assessment of product enclosure materials in drug product development.

  2. Response Factor Variation Study of Internal Standard for Semi-Quantitation of Extractables and Leachables Using LC-MS

    Eric Hill | Director, Extractables & Leachables Services of Boston Analytical

    Substances leached from pharmaceutical manufacturing components, package systems, and medical devices under laboratory conditions have been increasingly emphasized by regulatory bodies such as the US Food and Drug Administration (FDA) and The European Medicines Agency (EMA). The safety impact of the leached substances on patients depends on the discovery, identity and amount. Currently, the concentration of the leached substances above the Analytical Evaluation Threshold (AET) is frequently quantitated using an internal standard assuming equivalent response factors. Such an approach is accurate only if the responses of the internal standard and the leached compound are similar. However, the extractables profile always results in a wide variety of compounds. Therefore, not all internal standards are suited for concentration estimation. Herein, to establish accuracy of the internal standard approach, a comprehensive response factor variation study for semi-quantitation of extractables and leachables is reported. The results will be given for selecting the suitable non-volatile internal standards to semi-quantitate the extractables and leachables to its greatest possible value.

    Bullet Points: Internal Standard Selection Non-volatiles Extract Analysis LC-MS Q-TOF Compound Analysis and Quantitation Mass Spec Response Factor Comparisons Extractables Compound Identification and Quantitation

  3. In silico methods to assess the toxicity of extractables, leachables and degradants

    Candice Johnson, Ph.D. | Research Scientist of Leadscope, Inc.

    Candice Johnson, Dave Bower, Kevin Cross, Scott Miller, Glenn Myatt

    Leadscope, Inc. 1393 Dublin Rd, Columbus, OH 43215, USA

    (Q)SAR modeling can be used in the absence of empirical data to assess the genotoxic potential of extractables, leachables and degradants. In this poster we demonstrate how in silico tools are used to make predictions of genetic toxicity using principles that are in line with ICH M7 guidelines. Several case studies will highlight the implementation of in silico tools with focus on the transparency and interpretation of the results. Additional models and databases to support hazard assessment for endpoints such as skin sensitization and irritation/corrosion will also be discussed.

  4. Evaluation and Comparison of Sample Preparation Techniques and Analytical Instrumentation for Extractable Testing

    Anna Michelson, Ph.D. | Scientist in Trace Organic Labs of Intertek

    Anna Michelson Ph.D., Gyorgy Vas Ph.D., Louis Fleck, John Duett, Nan Zhang, Jacquelyn Cali

    Intertek Pharmaceutical Services, Whitehouse NJ

    Choice of extraction technique is often critical for the outcome of an extractable study. Chromatographic profiles for various extraction techniques (closed pressurized vessel (CPV), temperature controlled orbital shaker, accelerated solvent extraction (ASE), reflux) are compared.

    In addition, importance of high resolution instrumentation for proper identification is highlighted for GC-MS and LC-MS data.

  5. Sources of Interlab Variation in Medical Device Extraction Studies

    Dr. Matthew Jorgensen | Senior Extractables and Leachables Expert of Nelson Laboratories

    Co-author: Michael R Groendyk, Quality, Biocompatibility & Sterilization Management, Arthrex 

    The top several potential causes of iterlab and intralab variation have been identified and will be discussed. The single most significant causes relate to details of the extraction of the medical device and handling of extract liquids prior to instrumental analysis. This presentation will discuss these causes of variation and their potential consequences on toxicological risk assessment.

    Bullet Points: Sources of Interlab Variation for Medical Device Extractables Critical Extraction and Sampling Parameters Toxicological Risk Assessment of Medical Devices

  6. Effect of Mobile Phase Composition on Relative Quantitation of E &L Compounds using ELSD, Mass Spectrometry and UV Detection

    Dr. David Weil | Senior Application Scientist of Agilent Technologies

    David A. Weil and Michael Woodman; Agilent Technologies, Wood Dale, IL 60191

    The objective of E/L analysis is to accurately identify E/L compounds above the analytical evaluation threshold (AET) and safety concern threshold (SCT). It is well documented that changes in mobile phase composition (buffers, organic solvent, pH) can dramatically effect response of E/L compounds.  The use of Universal detectors such as Evaporative Light Scattering Detection (ELSD) and Corona Discharge Detection (CAD) are commonly used in series with MS Detection. Certain classes of compounds such as Parabens and Phthalates, due to volatile nature of the compounds don’t work as well using ELSD/CAD.  The poster will explore the impact organic solvent composition has on the relative responses and baselines of the various system then using standard reverse phase gradients versus using a make-up flow pump to keep mobile phase composition constant at 50/50 Water/Organic solvent.