Key Moments from the 2024 Extractables & Leachables Asia Event:
Dr. Ravi Kiran Kaja is a distinguished researcher and dedicated scientist with a Ph.D. in Analytical Chemistry and over 20 years of experience in Pharmaceutical Analytical Research (FAR&D). His career is fuelled by a steadfast commitment to enhancing patient outcomes through innovative pharmaceutical solutions.
Dr. Kaja's expertise spans Complex formulation characterization, Extractable & Leachable (E&L) studies, Pharmaceutical Manufacturing, and Science and Technology (MS&T) as well as Technology Transfer. He believes that collaboration and knowledge sharing are key to advancing the industry.
Beyond his professional endeavours, Dr. Kaja is passionate about mentoring young scientists and engaging in community outreach to inspire the next generation of researchers. His unwavering dedication to both his work and the broader scientific community has earned him respect and admiration in the field.
Dr. Dujuan Lu serves as the manager for the extractables and leachables (E&L) team at the SGS Fairfield New Jersey facility as well as the global leader amongst the three centers of excellence for E&L testing. Before joining SGS, she worked at Fresenius Kabi as a research scientist, leading E&L projects to support transfusion and infusion medical device and parenteral products. She has extensive CRO and pharmaceutical/medical device industry experience with more than 500 E&L projects on a broad range of packaging systems, including process materials, pharmaceutical finished packaging, and medical devices. As a subject matter expert in the E&L field, she is frequently presenting at various conferences as invited speakers and technical session chairs. She was named one of the top 60 most influential people working in the pharmaceutical industry in the Medicine Maker’s 2020 power list.
Dr. Lu obtained her PhD in analytical chemistry from the University of Pittsburgh and BS in chemistry from Nanjing University. She has authored more than 15 high-impart journal publications with more than 300 citations. She is serving as an expert reviewer for more than 10 prestigious journals in the field of analytical chemistry and pharmaceutical science.
Jia Min, Boo is the Technology Manager for Asia Pacific from West Pharmaceutical Services. She is based in the Singapore office. She joined West as a Technical Account Specialist in Technical Customer Services (TCS) and later progressed to the role of Senior Technical Account Specialist. In her TCS role, she provides technical support to pharmaceutical companies in the AP region through product recommendations, technical trainings and consultations to ensure smooth and easy uptake of West’s wide product portfolio for customers' drug product applications. As Technology Manager, in addition to providing TCS support to customers in Australia, she works closely with relevant stakeholders to develop in-depth knowledge of industry and technology. By understanding the technical regulatory requirements, she transforms these into scientific insights for customers and the industry. Additionally, she is also managing the AP Technical Services Lab, which mainly supports West internal projects. Jia Min holds a Bachelor degree in Material Science Engineering from Nanyang Technological University in Singapore.
Wenjing Zhao is a biological technical manager in Fresenius Medical Care and has the responsibility for biocompatibility and chemical characterization of medical device, as well as the compatibility of drug-packaging materials. She worked in Medtronic as senior scientist in charge of medical devices of Chemical Characterization and Materials of Concern for 7 years. Wenjing graduated from Soochow University and had been engaged in the research and development of Pharmaceutical Chemistry and Medical Device for over 12 years. She is good at Medical Device Chemical Characterization, Materials of Concern, and Polymer science.
Jiang Yan, the Director of Packaging Materials and Pharmaceutical Excipients Testing and Research Department at Sichuan Institute for Drug Control. A visiting scholar at the University of Massachusetts College of Pharmacy and Health Sciences (MCPHS), a CNAS assessor, and an authorized signatory in the field of pharmaceutical packaging materials. With 20 years of experience in the testing and quality research of pharmaceutical excipients and packaging materials, I have led over a hundred research projects related to compatibility for drug and packaging material and containers, integrity test for container closure system. I have been involved in drafting the standard methods for the guidance of rubber closures, plastics, metals for the Chinese Pharmacopoeia. I have won one second-class prize for technological progress from Sichuan Province, hold six national invention patents, and have published more than 20 professional papers.
Prabhakar has joined USP in January of 2020 and he is currently the Director of Pharmaceutical Sciences, General Chapters, and works with Microbiology, Dosage Forms and Packaging & Distribution Expert Committee related activities. He is also the scientific lead for the Complex Generics initiatives at USP, including developing standards for Extractables & Leachables, as well as other complex products such as Complex Injectables, Ophthalmics, Topical & Transdermal, Nasal & Inhalation products.
Prior to joining USP, Prabhakar worked in the pharmaceutical industry for more than 27 years at various small and large pharmaceutical companies in the field of analytical and bio-analytical chemistry. His expertise includes analytical and bioanalytical method development and validations, use of modern analytical technologies such as HPLC/UPLC and LC-MS/MS for characterization of both small and large molecules, use of automated instrumentation (TPW, and Sotax AT MD) for assay and dissolution testing, ICH stability testing, and preparation of regulatory documentation for IND/ANDA/NDA submissions.
Prabhakar has BS and MS degrees in chemistry and PhD degree in bioanalytical chemistry.
Dennis Jenke is the Chief Executive Scientist for Triad Scientific Solutions, a provider of science-based solutions to plastic/product compatibility challenges associated with packaging, manufacturing equipment and delivery devices in the pharmaceutical, cosmetic, food and related industries. He was a Distinguished Scientist at Baxter Healthcare Corporation where for more than four decades he lead a team whose primary responsibility includes the assessment of material/product compatibility, specifically with respect to establishing the suitability for use of packaging systems, manufacturing systems and administration devices for pharmaceutical products (for example, extractables/leachables and product ingredient binding)
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.
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.
Wenjing Zhao is a biological technical manager in Fresenius Medical Care and has the responsibility for biocompatibility and chemical characterization of medical device, as well as the compatibility of drug-packaging materials. She worked in Medtronic as senior scientist in charge of medical devices of Chemical Characterization and Materials of Concern for 7 years. Wenjing graduated from Soochow University and had been engaged in the research and development of Pharmaceutical Chemistry and Medical Device for over 12 years. She is good at Medical Device Chemical Characterization, Materials of Concern, and Polymer science.
Kok Li Kwang is the Director of Scientific Affairs and Technical Services for Asia Pacific at West Pharmaceutical Services. She leads a team of technical professionals to support pharmaceutical manufacturers in the Asia Pacific region in their injectable drug packaging needs, including material characterization of packaging and analytical solutions. She works closely with her team to identify changing industry dynamics and offer efficient and holistic packaging solutions to enable customers to meet the increasingly stringent drug product requirements. Driving customer satisfaction and contributing towards patient safety are her key focus areas. Kok Li holds a Bachelor’s degree in Chemical Engineering from the National University of Singapore and has more than 18 years of experience in the pharmaceutical and medical diagnostic industry.
Yang Chao, the Biological Evaluation Senior Engineer at the Product Safety Department in Mindray, is responsible for the biocompatibility evaluation of the company's Endoscope Instruments and the verification research of reusable instruments' reprocessing. He is also responsible for the test and verification of the ISO18562 series(PM、VOCs and E&L) for the gas monitoring module of the monitor. With 15 years of experience in testing and verification in the medical device industry, Yang is a Reviewer in the biomedical field of Shenzhen Science and Technology Innovation Comm as well. Prior to Mindray, he worked at the Beijing Institute of Medical Device Testing, with the title of senior engineer.
