Andrew Teasdale PhD has over 25 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role he chairs AstraZeneca’s Impurity Advisory Group. Dr Teasdale has published a number of papers relating to extractables and leachables, mutagenic impurities and other impurity related matters. He is currently the chair of the Extractables and Leachables safety Information exchange (ELSIE) and also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI) . Andrew has also represented EFPIA in both ICH Q3C and Q3D Expert working groups and the newly established ICH Q3E EWG relating to Extractables and Leachables. He has also advanced a number of key scientific advancements in the control of impurities as the inventor of the purge factor concept and the instigator of the development of Elemental Impurities database for excipients. With over 50 scientific papers, he has also written 2 books:
Genotoxic Impurities – Strategies for Identification and control. Editor A Teasdale. Publisher Wiley. ISBN 978-0-470-49919-1
ICH Quality Guidelines – An Implementation Guide. Editors A Teasdale, D Elder, R W Nims. Publisher Wiley. ISBN 978-1-118-97111-6.
Queenie Gai received her M.S. in Analytical Chemistry from East China University of Science and Technology. With more than 7 years E&L experience, she now serves as global E&L Senior Consultant of Merck BioReliance Validation Services (BVS) Laboratory. BioReliance Validation Services supports Merck’s overall strategy and execution of E&L studies for the development and application of Single Use System. Her experiences include method validation, designing of custom testing and interpreting industry and regulatory guidance.
Xiaoxia Ye is the manager of trace impurity investigation lab at Huadong Medicine. She is responsible for E/L and trace-impurity-related studies for pharmaceutical products. Xiaoxia Ye obtained Ph.D. degree from University of Alberta and has more than 15 years’ experience in chemical characterization using mass spectrometry.
Dr Guangming Wu graduated from department of Polymer Chemistry and Physicals in Zhejiang University in 2009, with extensive research area of rare-metal catalyst synthesis, characterization and application in polymerization. In 2009, he joined Shanghai Institute of Organic Chemistry as post-doc researcher to focus on the scale up and industrialization of first patented alpha-olefin catalysis with higher purity. After that in 2011, He joined SABIC as Scientist to develop high transparency Lexan product, PP and PE product, from lab formulation, compounding to application in customer side, several grades are developed and applied in LED application, medical packaging etc.; in 2014, he worked as Technical Leader to lead the peritoneal dialysis product development in China and Malaysia, pharma packaging is the major focus; In 2019, he joined SCHOTT P as Technical Customer Manager, responsible for glass packaging technology training to internal and external customers, customer service etc. 14 publications and 2 patents are published.
Mr. Yang Xiaojun joined Shanghai WEIPU Chemical Technology Service Co., Ltd. in 2018 as the technical director of compatibility study, responsible for the operation of the compatibility study team. He has been in the field of compatibility research since the first guideline for compatibility of plastic packaging materials were issued in 2012. In the past ten years, he wasdedicated to the compatibility study of various in-process components, packaging materials and drug delivery devices in the whole life cycle of drugs, with more than 1000 compatibility project application experience. In addition, he has participated in the drafting of guiding principles for compatibility study of chemicals drugs and elastomers. He has unique experience and skills in the field of compatibility and can provide customized compatibility study solutions for customers.
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.
Carsten Worsøe is a research scientist in an analytical development department at Novo Nordisk. In over 18 years at Novo Nordisk, his main responsibility has been to develop analytical methods for L&E test procedures of new packaging/container closure systems under development. Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in packaging materials, toxicology, formulation, regulatory and analytical together to perform risk assessments and strategies for L&E testing in development projects.
Dr. Lei Zhang, the analysis director of Shanghai Henlius Biotech, Inc., has 14 years of experience in analytical and biopharmaceutical quality research. He has successively worked in the mass spectrometry center of Shanghai Institute of organic medicine, Agilent (GC/LC-FTMS Department), GE (Shanghai R & D center, AIMS Department) and Sunshine Guojian (Shanghai) Co., Ltd. His work focuses on the analysis of chromatography, mass spectrometry and electrophoresis, as well as the quality research on therapeutic proteins and application support at different stages of the process development and production of biological drugs, especially the research on the structure, purity & impurities and E & L studies.
Xiaoxiang Li, Manager, Scientific Laboratory Service Validation, Pall Corporation. Xiaoxiang is responsible for advanced Extractable and Leachable validation for Single-Use System and sterile filter. Since she joined Pall in 2015, Xiaoxiang has been responsible for implementation of BPOG / USP <665> standardized protocol on extraction testing for polymeric materials, components and systems in biomanufacturing and created Pall in-house E/L library collaborated with Pall global teams.
Dr. Norwood is an internationally recognized expert in the field of leachables and extractables assessment in pharmaceutical development and manufacturing. He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on leachables and extractables in inhalation drug products. He is also a member of the PQRI Working Group on leachables and extractables in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). Since 2010, he has served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on extractables and leachables. Dr. Norwood has received several industry awards, including the CEO’s Award from Glaxo (1994), the President’s Award from Boehringer Ingelheim (2007), the Excellence in Research Award from PQRI (2009), and the Award for an Innovative Response to Public Health Challenges from USP (2013). Dr. Norwood completed his bachelor’s degree in Biochemistry at Virginia Tech and his doctorate degree in Environmental Chemistry at the University of North Carolina at Chapel Hill, School of Public Health.
Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.
Mr. Hovery Yin got his master degree from East China University of Science and Technology with major in Analytical Chemistry, had 8 years of analytical R&D experiences in biopharma industry. He is currently the Extractables/Leachables Project Specialist in Sartorius Validation Services department. He is responsible for technical support of validation and project management for Single-Use System (SUS) .Prior to Sartorius, he worked for United States Pharmacopeia Convention as Analytical Scientist to develop analytical methods for Pharmacopoeia monograph and then had role as Technical Manager of Extractables & Leachables in NSF International.
He is the Director of Chemistry department at Shandong Quality Inspection Center For Medical Devices . He has 12 years research experience in medical device and drug packaging evaluation. He is Committee member of National Standardization Technical Committee on Infusion equipmen. He also sits in ISO/TC194 (Medical Device Biological Evaluation) and ISO/TC76 (Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use) working group.
Wenjing Zhao is the chemistry scientist of Medtronic Technology Center in Greater China. She is responsible for the Chemical Characterization work for the whole MTC medical devices. She graduated from Soochow University and had been engaged in the research and development of Pharmaceutical Chemistry and medical device for 10 years. She is good at chemical synthesis, chemical analysis and chemical characterization, and she is also familiar with Macromolecular chemistry.
Dongdi Sun is the director of chemistry lab which mainly provides customized chemistry testing services, including chemical characterization of medical devices materials, drug packaging materials compatibility study, target compounds method development & validation and testing. Dongdi Sun obtained Ph.D. in chemistry from Mississippi State University in the United States. He has 11 years’ research experience in analytical chemistry including 5 years of research experience in chemical characterization of medical devices and drug packaging material compatibility study. In 2019, he won the honorary titles of "doctor of entrepreneurship and innovation of Jiangsu Province" and "high level talents of science and technology innovation and entrepreneurship of Soochow".
Lin Chunxin has over 8 years of E&L project operation experience, handling more than 1000 varieties of E&L projects. He is familiar with domestic and overseas regulations, and has accumulated extractables and leachables research skills.
Fangfang has nearly 17 years experiences in the compatibility of food and pharmaceutical packaging material and work as senior engineer and deputy director of Analysis department in Shanghai Food and Drug Packaging Material Control Center.
She has been engaged in the research of quality standards and method development of food and pharmaceutical packaging materials, and is good at the design of experimental scheme. Familiar with the quality standards, guidance and regulations of container closure system, she participated in quality standards development and published and participated in more than 10 professional papers, with one invention patent and one utility model patent. In 2016, she went to Extractable and Leachable laboratory in Illinois for advanced study.
Lynn currently serves as Scientific Affairs Manager (China) in West Pharmaceutical Packaging (China) Co., Ltd., in her role, Lynn helps to review and analyze the industry development as well as the regulatory changes in China for injectable and offer scientific advice.
Lynn joined West as a Technical Support Engineer, providing technical support in mainland China. Before joining West, Lynn worked in a technical support supervisor role with a company dealing with biochemical and microbiological reagents after she graduated from University with a Master degree in Biochemical Engineering.