- Overview
- The issue of extractables and leachables
- Why do we care?
- History of extractables/leachables concern
- Pre-1990
- Post-1990
Paul Cummings | General Manager E&L, Smithers
The 2021 agenda has been announced! Featuring speakers from Intertek, Aspen Research, Becton Dickinson, PPD, AstraZeneca, and more, discussing industry-leading topics, such as materials contributions, analytical challenges, case studies, and much more.
Add the Masterclass Introduction to Extractables and Leachables to your agenda!
We are very excited to be presenting our introductory “Master Class” on E&L. While we will be focusing on the fundamentals, this workshop will also prove valuable to anyone who needs to know the latest trends in extractables and leachables. We look forward to seeing you there!
Cost: $249.00 USD
Register
As general manager, Paul is responsible for the Smithers Analytical Services lab located in Akron to support extractables and leachables studies for the medical device, pharmaceutical and food industries. The lab also provides chemistry support to Smithers Rapra’s existing analytical and physical testing laboratories.
Paul’s specialty areas of expertise include mass spectrometry with a significant background in small molecule structure elucidation. He also has extensive experience in extractables and leachables and other areas of packaging testing such as container closure integrity.
Paul brings over 35 years of experience in chemistry and leadership in the pharmaceutical industry. Most recently he was a Research Fellow and Manager of Trace Organic Analysis for Intertek Pharmaceutical Services. He has also worked at West Pharmaceutical Services, Drugscan, GlaxoSmithKline and Merck.
Paul holds a Bachelor of Science degree in Chemistry from Old Dominion University and a Master of Science Degree in Analytical Organic Chemistry from Villanova University. He also served his country in the United States Army.
Theodore (Ted) Heise has three decades of experience in regulatory and clinical affairs, and currently serves as Vice President Regulatory and Clinical Services at MED Institute. In this capacity, Dr. Heise leads efforts to develop scientifically robust regulatory and clinical study strategies for the company’s clients: entrepreneurs, consultants and developers bringing new medical products through the complex steps of the development process.
Graduating Magna Cum Laude with a B.S. in chemistry from the University of Nebraska at Omaha, Dr. Heise went on to earn a Ph.D. in analytical chemistry from Iowa State University. He has been a member of the Regulatory Affairs Professionals Society since 1993, and the American Chemical Society since 1988.
For the past 12 years Dr. Heise has been a U.S. delegate to ISO TC 194, the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices. He currently serves as convenor of TC 194/WG 14. As convenor, Dr. Heise led the process of re-writing ISO 10993-18 to reflect current best practices in chemical characterization, including evaluation of extractables and leachables.
Gyorgy Vas has over 20 years of experience in scientific research, product development, and laboratory management. Much of that time has been spent in a cGMP environment, where he has provided his expertise to solve problems related to finished pharmaceutical products and medical devices.
In his current position, he advises on regulatory filing strategies for multiple clients, and his group provides solutions for mitigating deficiency letters. Gyorgy led the implementation of state-of-the-art solventless sample preparation techniques into the cGMP laboratory processes, and is one of the few in this field with expertise in method development and validation for ultratrace (parts-per-trillion) level impurities in finished pharmaceutical products and medical devices.
Bio to be added shortly
Dr. Alan Hendricker has 15 years of experience in extractables and leachables analysis and 25 years of experience with mass spectrometry. He received his undergraduate degree from Ohio University and Ph.D. from the Colorado School of Mines in 1999. He was a co-author on the PQRI Working Group on Leachables and Extractables recommendation “Safety Thresholds and Best Practices for Leachables and Extractables in Orally Inhaled and Nasal Drug Products (OINDPs).” He has been an active member of the PQRI Leachables and Extractables Parenteral Ophthalmic Drug Product (PODP) working group. He has written and presented extensively on extractables and leachables issues. Alan was a member of the Structural Chemistry Group at Magellan Laboratories through its acquisitions by Cardinal Health and subsequent purchase by the Blackstone Group as Catalent Pharma Solutions. Since January of 2014, Alan works at Becton Dickinson (BD) as part of the corporate preclinical development group on extractables and leachables studies for BD devices and products.
Dr. Yu has been leading extractables and leachables study since 2003, providing scientific leadership, technical and regulatory guidance to the team members and many clients for the design and execution of extractables/leachables programs. His team have successfully completed hundreds of extractables and leachables studies for numerous drug products, including pMDI, DPI, parenteral, ophthalmic, transdermal and oral dosage forms as well as medical device and drug/device combination products etc.; in the past three years, there are at least 25 drug products approved with extractables and leachables studies completed by Dr. Yu's team.
Currently a Staff Scientist with AstraZeneca in the Research Triangle Park (RTP) working on extractables and leachables (E&L). I have been in the field since 2001. I began my E&L career extracting and analyzing flavor compounds from soy protein. In 2005 I began to work with pMDI container closure systems. Currently manage the E&L activities at RTP and support other R&D groups within AstraZeneca. A member of the Materials Working Group within ELSIE and Knowledge Base sub-team I have been supporting the development of an extractables knowledge base. A member of the IPAC-RS Materials working group and involved with defining medical grade plastics and bio-compatibility. I have a Ph.D. in Physics from the University of Wyoming.
Praneeth received his PhD in analytical chemistry from the University of Illinois at Chicago. He has been responsible for the design and execution of E/L studies and impurity identification with a focus on the use of mass spectrometry. Praneeth has more than two decades of experience in the area of analytical mass spectrometry both in the pharmaceutical and chemical industry. Praneeth has performed extensive research in the drug discovery field as a postdoctoral fellow as well as NIH fellow. He has several publications and patents.
Bio Coming Soon
Born: 10.09.1981 in Piekary Śląskie, Poland
Alicja is currently employed at the Octapharma where she is responsible for material qualification at corporate level including chemical safety assessment of polymerc processing, packaging, and administration materials and the planning and supervision of extractables and leachables studies.
Prior to joining Octapharma, Alicja had a tenured position as a researcher at the French National Institute for Agricultural Research (INRA) where she investigated various possibilities to increase sustainability in the food processing industry. Alicja has compelled broad experience in material and polymer science and technology at the Institute for Composite Materials (IVW) in Kaiserslautern as well as at the Centre for Neutron Science (JCNS) and at the Institute for Nuclear Waste Disposal and Nuclear Safety (IEK-6) at the Research Centre in Jülich, Germany.
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Mexico and Sweden. For more information visit www.octapharma.com.
Bio Coming Soon
Coming Soon
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.
Dr Andrew Feilden joined Hall Analytical in November 2019 as the European E&L Strategic Director. He is a technical expert in the field of E&L testing, having been involved in the field of E&L for over 20 years. At Hall he undertakes Commercial, Operational and technical thought leadership activities.
Andrew has presented on the field of extractables and leachables in over 16 countries worldwide. He has written a number of papers and publications and is the inventor of 2 patents.
He has a degree and D Phil from the university of York, is a Fellow of the Royal Society of Chemistry and was a Scientific Advisor to IPAC-RS and ex-co-chair of ELSIE.
Dr. Stanard is currently the Director, EHS Product Stewardship at Ultragenyx and previously lead Global Occupational & Quality Toxicology at AstraZeneca. Dr. Stanard has over 20 years of experience in the biopharmaceutical industry covering a broad spectrum of responsibilities in the drug development process within R&D, clinical and commercial manufacturing operations. During this time, his primary focus has been on hazard identification and hazard/risk assessment, including occupational exposure limits and derivation of daily exposure values for extractables and leachables, APIs, intermediates and impurities. Dr. Stanard received his PhD in toxicology from Colorado State University and an MPH in toxicology from San Diego State University. He is a Diplomat of the American Board of Toxicology. Dr. Stanard is an active member of the Extractables and Leachables Safety Information Exchange (ELSIE), serving as the co-chair of the Safety Working Group and member of the Executive Committee and Board of Directors.