E&L China has well gathered E&L experts from home and abroad to discuss E&L regulations and technical issues, which can effectively improve the knowledge of domestic biopharma company on E&L and improve the technical level of relevant research institutions. - Sartorius
The Fifth Extractables & Leachables China 2022 will return to Shanghai, China on 3-4 November 2022 and explore the latest technological advancements, regulatory updates, progress in analysis of new materials for pharmaceutical packaging, new developments in medical & drug device combination products and much more! This event will deliver high level insight into the market and global regulatory landscape, while allowing extensive time for debate and networking.
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.
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.
Weipu biomedical R&D and laboratory services Technical expert of compatibility research
Ms. Chang graduated from Tongji University, focus on analysis and detection, with 8 years of experience in compatibility research of drug packaging materials, components and appliances, and elemental impurities. Ms. Chang is familiar with the guiding principles and regulatory requirements related to compatibility research at home and abroad, such as USP1663/1664、665/1665、PQRI、BPOG、ICHM7、ICHQ3、Four domestic compatibility guidelines and so on.
Ms. Chang participated in and was responsible for more than 2000 compatibility research projects, participated in and took charge of nearly 200 projects successfully declared at home and abroad, familiar with the technical requirements for review and approval at home and abroad, combining rich research strategy experience with advanced LCMSMS, GCMS, ICPMS and other technical platforms, service customers include Beisheng Research, Qilu Pharmaceutical, Yangzijiang Pharmaceutical, Changchun Biotech, Yichang Humanwell, Guilin Nanyao, etc
Mr. Hovery Yin holds master’s degree of analytical chemistry from East China University of Science and Technology, has nearly 10 years of analytical R&D experience in biopharma industry. Familiar with the global regulations and technical guidance of E&L study, has rich practical experience in E&L study which has completed hundreds of drug packaging, process plastic components and medical device E&L projects. He has participated in several times of NMPA on-site audit, familiar with the quality requirements of the laboratory management system.
He is currently the E&L Project Manager in Sartorius Confidence® Validation Services. 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 as Scientist to develop analytical methods for pharmacopoeia standards and then had role as Technical Manager of Extractables & Leachables in NSF International.
Master of Analytical Chemistry, He has worked for a long time in the Provincial Institute of drug control and authoritative international third-party testing institutions; and deeply engaged in the field of pharmacy, materials and consumer goods testing for over 20 years, with experienced chromatography, mass spectrometry and spectral detection technologies. he is familiar with pharmaceuticals R&D, registration regulations and application requirements. At present, he is responsible for the compatibility research of drugs, packaging materials, production components, SUS and medical devices.
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.
Weipu biomedical R&D and laboratory services Technical expert of compatibility research
Ms. Chang graduated from Tongji University, focus on analysis and detection, with 8 years of experience in compatibility research of drug packaging materials, components and appliances, and elemental impurities. Ms. Chang is familiar with the guiding principles and regulatory requirements related to compatibility research at home and abroad, such as USP1663/1664、665/1665、PQRI、BPOG、ICHM7、ICHQ3、Four domestic compatibility guidelines and so on.
Ms. Chang participated in and was responsible for more than 2000 compatibility research projects, participated in and took charge of nearly 200 projects successfully declared at home and abroad, familiar with the technical requirements for review and approval at home and abroad, combining rich research strategy experience with advanced LCMSMS, GCMS, ICPMS and other technical platforms, service customers include Beisheng Research, Qilu Pharmaceutical, Yangzijiang Pharmaceutical, Changchun Biotech, Yichang Humanwell, Guilin Nanyao, etc
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.
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.
Xie YangGuo majored in medicinal chemistry and received his medical Ph.D dgree from Shanghai Jiaotong University in 2019. In the same period, he joined Shanghai Henlius Biotechnology Co., Ltd. as the Senior Supervisor E&L Formulation Analysis, mainly engaged in E & L study of container closure system and single use system in biopharmaceutics. He was familiar with analytical techniques including LC-QTOF, LC-QQQ, GC-MS, HPLC and ICP-MS. In addition, he was in charge of E&L method development of several projects and published 2 related papers.
Fu Peilin, R&D center director, Shenyang Sinqi Pharmaceutical Co.,Ltd., Ph.D of pharmaceutical analysis, Shenyang Pharmaceutical University; Master’s supervisor, China Medical University; Pharmaceutical analysis expert, China Medicine Education Association; China youth May 4th Medal; Person in charge of public platform for science and technology services of "compatibility of pharmaceutical products and packaging research", Shenyang Bureau of Science and Technology; Specializing in the compatibility of pharmaceutical products and packaging materials; Co-edited the first book in China — “Theory and Practice of Compatibility of Pharmaceutical Products and Packaging”.
• Senior Scientist 2013 - present, Baxter Healthcare Cor. (Suzhou R&D)
• 15+ years experiences in analytical chemistry including using chromatography with mass spectrometry, structure elucidation, method development and validation, etc.
• Deeply involved in E&L assessment, structure elucidation for unknowns, analytical method development and validation for targeted compounds, etc.
Weipu is a large research-based testing agency in China dedicated to laboratory technology services.
Weipu is founded in 2008, and the headquarter is located in Shanghai. Weipu has established (subsidiary) branch companies and offices in Guangzhou, Suzhou, Hangzhou, Qingdao, Chengdu, Jiaxing, Shenzhen, Beijing, Nanjing, Ningbo, Wuhan, Jinan and Changsha, and has set up specialized laboratories of various fields including chemistry,mate rials, mechanical physic, reliability, food, environment, medicine, biochemistry, and cosmetic efficiacy evaluation.
Weipu have qualifications (CMA and CNAS) approved and authorized by the state, and is recognized as national exemplary public service platform for small and medium-sized enterprises, academician expert workstation and high-tech enterprise.
Bio-pharmaceutical area:
Compatibility research of medicine contact materials and drug with packaging, packaging and sealing integrity research;
Genetic toxicity, residual solvents and medicine impurities analysis and testing;
Chemical medicine characterization, structure confirmation, excipients inspection, microorganism testing;
Original drug reverse engineering research;
Biological macromolecular structure confirmation and analysis;
Medical devices: Research and development of material testing, chemical characterization, leachate research, toxicology risk assessment, in vitro degradation experiments, animal experiments.
