June 28 - July 1, 2021
Arlington, VA
Dr. Dennis Jenke is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. In this role, he works with a team of analytical chemistry professionals whose primary responsibility includes the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples.
Dr. Dujuan Lu has been leading the extractables and leachables (E&L) team at SGS Fairfield New Jersey site since 2015. She has extensive pharmaceutical industry experience with more than 200 E&L studies on a broad range of container closure systems, including pharmaceutical finished packaging, process equipment (SUS, MUS, etc) and medical devices. Before joining SGS, she was working at Fresenius Kabi, leading E&L projects to support transfusion and infusion medical device and parenteral products. She has more than 10 years of experience on trace analysis by LC/MS and GC/MS.
Dr. Dujuan Lu obtained her PhD in analytical chemistry from the University of Pittsburgh. She has authored more than 10 peer-reviewed journal publications with more than 300 citations. She has more than 20 international conference presentations as invited speakers and technical session chairs. She is serving as an expert reviewer for more than 10 prestigious journals in the field of analytical chemistry and pharmaceutical science.
Doug obtained his BS and MS in Biology from St. John’s University, Jamaica, NY in 1977 and 1980, respectively and became board certified in general toxicology (DABT) in 2003. Doug is a full member of the American College of Toxicology (ACT), Society of Toxicology (SOT) and has served as President, VP and Secretary/Treasurer for the Northeast Chapter of SOT (NESOT). Doug was employed as a toxicologist at Sandoz (now Novartis) and Boehringer Ingelheim. Doug has assumed various project and regulatory strategy roles and is currently a Research Fellow in Regulatory Strategy and Compliance at Pfizer. Doug has been the Nonclinical Drug Safety Team Lead for 5 drug product approvals, the most recent being Xeljanz (tofacitinib citrate) for the treatment of rheumatoid arthritis.
A recognized expert in the evaluation and qualification of E&L in drug products. He co-chaired a PQRI L&E work group and co-authored the PQRI Best Practices Recommendations for Evaluation of L&E in Orally Inhaled and Nasal Drug Products (OINDP, 2006). Doug serves as a co-chair for the PQRI work team for L&E evaluation in parenteral and ophthalmic drug products (PODP), the Co-Topic Lead for the International Conference on Harmonisation (ICH) Expert Working Group (EWG) and Implementation. Working Group (IWG) for Elemental Impurities (Q3D), an Expert Panel member for USP <381> Elastomeric Closures for Injection and Biocompatibility <87> and <88>, and is past Chair and current Board member of ELSIE.
Benton Cartledge is a senior scientist with the extractable and leachables group at PPD® Laboratories. He received a bachelor’s degree in chemistry from the University of Indianapolis (Indiana, USA) and Ph.D. in analytical chemistry from the University of Denver (Denver, CO).
Pharmacist and doctor in toxicology with emphasis on degradation products. 10 years of experience in degradation chemistry, including stress testing, development of stability-indicating methods, identification and qualification of degradation products. She worked at Aché Laboratórios Farmacêuticos as senior researcher and, nowadays, is a consultant in the area impurities assessment that includes degradation products, mutagenic impurities, elemental impurities and extractable and leachable, offering both analytical and toxicological support at Spektra Consultoria, at which is founder.
Dr. Sahotra got his BSc in Chemistry from the University of Central Lancashire, followed by MSc in Drug Chemistry from Newcastle University. In 2018 he completed his PhD in organic chemistry. Since then he has been working for Markes International, specialist in thermal desorption technology. His current job involves the sampling and analysis of air borne chemical from products and materials.
At every stage—disease research, drug discovery/development, quality control, manufacturing—you need the right answers to make the best business decisions for your lab. Speed to decision is critical in any business. All pharmaceuticals must undergo rigorous testing to ensure that they are safe and effective, and products derived from biotechnology require even more sophisticated analytical procedures. Agilent can help meet your needs with high throughput automated systems for compound identification in early discovery and with sophisticated, highly sensitive analytical systems that can provide quick answers to routine questions—for both expert users and trained technicians.
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The U.S. Food and Drug Administration and European Medicines Evaluation Agency (EMEA) have expressed concerns over potential toxicity and efficacy effects of chemicals released into drug products through exposure to components used in manufacturing and packaging. These chemicals are referred to as Extractables and Leachables (E&L). Accurate and definitive E&L studies should be performed in compliance with USP, ICH, PQRI, and ISO 10993. All E&L studies by Daicel Pharma Services are conducted in their US-FDA audited analytical facility and fully support regulatory compliance. Daicel Pharma Services offers GMP Analytical Services with comprehensive Extractable and Leachables Studies and GMP Stability Studies. Daicel’s Extractable and Leachables studies test a large number of packing materials, manufacturing systems, and drug products, as well as offer Glass Delamination studies to meet the demanding testing specifications of regulatory authorities. Learn more at www.daicelpharmaservices.com
Performing an E&L study is an important part of verifying the safety of a medical, pharmaceutical or packaging product.
Design of an E&L study requires an understanding of the materials used in the construct of the product and the expected use conditions. E&L studies are best conducted using an analytical strategy which is formed by expectations of potential extractables, and which has sufficient breadth for discovery of unexpected components. The laboratory which conducts the study must have sufficient expertise in unknown identification to properly leverage information from multiple techniques, databases and control experiments to allow for positive unknown identification. They must also have the breadth of instrumentation which allows for analysis of a wide range of potential analytes. Finally, they must also be experts at analytical method development utilizing this knowledge to develop quantitative methods for the components identified.
Jordi Labs specializes in the analysis of plastics and has the experience and knowledge to make your E&L study a success. Jordi partners with our customers to develop and execute E&L studies empowered by over 30 years of analytical experience and state of the art instrumentation.
