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Agenda

Registration and Welcome
Registration Onsite
Chair’s Opening Remarks
KEYNOTE: Trace Impurities and Extractables: Are We Going Too Far for Safety Assessment?
Session 1: Global Regulatory Landscape and Updates on E&L
Updates on ICH Q3E Development And The Challenges Faced
This session will provide an update on the development of ICH Q3E and challenges ahead. The decision of developing a new chapter ICH Q3E Guideline Impurity is made and what the new chapter will look like, what and when it might be delivered.
Andrew Teasdale | Senior Principal Scientist – Impurity Management and External Advocacy, AstraZeneca
Interpretation of USP665 Latest Revision: How Standardized Extractables Data Support E&L Risk Assessment of Manufacturing Process
Plastic components used in pharmaceutical and biopharmaceutical manufacturing must be assessed for safety through an evaluation of extractables and potential leachables. The single-use system (SUS) suppliers started to generate datasets to support the drug manufacturer’s risk assessment.
This presentation will cover: 
•    Current industry guidelines established by USP <665> draft
•    End user’s process materials risk management
•    The use of standard extractables data from SUS supplier for risk mitigation
Queenie Gai | Global E&L Senior Consultant, Merck
Networking Break (sponsored by WEIPU)
Session 2: Insights and Perspectives from Pharma and Biotech Companies
How to Properly Design And Execute E/L Studies for Drug Delivery Systems of Parenteral Drug Products - from The Perspective of A Drug Products Manufacturer
The compatibility of parenteral drug products and their drug delivery systems has received increasing attention from regulatory agencies and pharmaceutical companies are required to perform compatibility studies while submitting drug applications. However, in most circumstances, for drug products manufacturers that do not produce drug delivery systems (e.g. base IV or infusion devices), it is difficult to control which brand/material of drug delivery systems the hospitals use. Therefore, it is important to properly design the compatibility test with limited lab resources. This presentation will illustrate general considerations for the design of E/L studies of drug delivery systems. And from the perspective of a pharmaceutical company, we will discuss whether it is always necessary to carry out extractable profiling experiments by presenting several case studies.
Xiaoxia Ye | Senior Analytical Researcher, Huadong Medicine
Panel: Challenges and The Future Trend of E&L Studies and Global Requirements
  • Comparison among different requirements globally 
  • The possibility of one biocompatibility evaluation report meeting multinational regulatory requirements
  • What’s the future trend of E&L 
Moderator:​ Xiaojun Yang, Technical Director of Biomedical Technology Center, Shanghai WEIPU
Panelists: Dongdi Sun, Director of Chemistry Laboratory, Medical Device Testing Center, WuXi AppTec
Xiaoxia Ye, Senior Analytical Researcher, Huadong Medicine
Weixing Yang, CTO, Qingdao Sci-Tech Innovation
Lei Zhang, Biology Analysis Development, Physicochemical Analysis Director, Henlius
Networking Lunch
Session 3: E&L in Pharmaceutical Packaging and Drug Delivery Systems
How to Select Glass Pharma Packaging: E&L Perspective
Challenges of E&L Study on Chemical Drugs (parenteral) And Drug Delivery Systems
Drug delivery system is a special device used in treatment of disease. Because the drug delivery system is normally composed of polymer with high level of additives, so it is necessary to design a scientific and reasonable E&L study on drug delivery system and related drug product.
This presentation will give a brief introduction on the challenges of such E&L study:
1: Which type of drug delivery system should to be considered?
2: Which material of drug delivery system should be chosen for E&L study?
3: How to design a scientific E&L study on drug delivery system and related drug product.
 
Xiaojun Yang | Technical Director of Biomedical Technology Center, Shanghai WEIPU Chemical Technology Service Co., Ltd.
Extractable And Leachable Testing for Transdermal Drug Delivery Systems
Transdermal drug delivery systems are relatively complex pharmaceutical products. The formulation contains multiple excipients and in addition a dermal contact adhesive. The performance of the delivery systems depends on the quality of the dermal adhesive and the formulation, which delivers the drug on a pre-determined rate. 
The dermal delivery route is getting more and more popular, since the effect of the delivered drug can be localized, which may reduce or even eliminate the systemic side effects. However, since the formulation has extended contact time, besides the drug is being delivered excipients, degradation products and packaging related components can also be non-intentionally “delivered” with the same route of administration.
The extractable testing of transdermal systems is straightforward, does not requires “out of box” thinking. In contrary the leachables testing requires more complex approaches, as the regulatory expectation is to test the finished products with biologically relevant extraction media. 
The presentation will focus on different test approaches, to present options for leachable testing, how to evaluate the actual leachables and validate analytical methods what are requires non-routine extraction methods and as well detection capability down to ppb level. Few examples also will be provided for mitigating FDA deficiency letters related to transdermal delivery systems. 
The complex formulation combined with the low level testing requirement are very challenging analytical task. Component identification, analytical method development and validation are not as simple as for the components present at a ppm level or above.
 
Gyorgy Vas | Technical Scientific Liaison, Intertek
Networking Break (sponsored by WEIPU)
Session 4: E&L in Single Use Systems
BPOG E&L SUS – The Final Chapter
•   Supplier and end-user collaboration
•   Extractables ecosystem
•   Data review process
•   Extractables protocol update 
•   Community of practice
Haiyan Hong, R&D manager, Saint-Gobain Research Shanghai
Carsten Worsøe | Principal Scientist Extractables and Leachables, Novo Nordisk
Introduction on E&L Study of Single Use System Used in Monoclonal Antibody Manufacturing Process
Single use systems (SUS) have been widely used in biopharmaceutical industries in recent years. SUS or SUS components have many advantageous application either in clinical or in commercial manufacturing. Accordingly, the general requirements for extractables and leachables (E&L) are enacted by regulation in USA, EU, and China. For the specific regulatory requirements on E&L, China has only issued the guidelines as to the primary packaging systems (i.e. plastics, elastomer and glass) of chemical drug products. Henlius uses SUS in all stages of antibody drug manufacturing processes, and the submitted E&L study, in accordance with BPOG & USP guidance, had been accepted by NMPA and EMA for NDA/MAA application. The presenter will give a brief introduction on the domestic and international regulatory expectations as well as industrial approach on E&L study. Additionally, some case studies will be shared and discussed during process development and post approval changes.
Lei Zhang | Physicochemical Analysis Director, Shanghai Henlius Biotech , Inc.
Study of Extractable And Leachable Produced in Single-Use System Based on The Best Practice
Determination of extractable and leachable (E&L) from polymeric materials, components and systems used for manufacturing pharmaceutical products and biopharmaceutical substances and products is important. Extractables generated in reasonable worst conditions can be used to evaluate potential leachables, which can adversely alter a key quality of DP and pose a risk for patient safety. Analytical Instruments such as LC/MS, GC/MS and ICP/MS are often used to identify and quantify organic E&L compounds and elemental impurities. In this presentation, we will share our experiences of identifying organic E&L compounds based on executing standardized protocols (BPOG and USP <665>). The increasing availability of extractable datasets aligned to standardized protocols has led to a deeper understanding of extractable profiles in different solvents. The aim of these studies is to drive further industry alignment among suppliers, end users and regulators that improves the evaluation on extractable and leachable compounds and its risk based on the best practice.
Xiaoxiang Li | Manager - Scientific Laboratory Service Validation, Pall (China) Co., Ltd.
Registration and Welcome
Registration Onsite
Chair’s Opening Remarks
Session 5: Challenges in E&L Profiling: Identification
Challenges in E&L Profiling: Identification
This session will share a case study on the identification challenges in E&L study.
Daniel L. Norwood | Executive Partner, Feinberg Norwood & Associates Pharma Consulting
Session 6: Safety Assessment and Toxicology
Best Practices for Deriving Health Based Exposure Limits for E&L Compounds
Health Based Exposure Limit (HBEL) values, like Permissible Daily Exposure Limits (PDE) for compounds released from pharmaceutical packaging and Tolerable Intake (TI) values for compounds released from medical device materials, are toxicity-based limits used for the safety assessment of E&L compounds.  Although the specific approaches to derive PDE and TI values differ slightly, the general principles for establishing these HBELs are fundamentally consistent.  This presentation will provide practical guidance for the derivation of HBEL values (both PDE and TI) that are likely to be accepted by regulatory agencies.  Best practices will be reviewed for selecting key toxicity studies that can serve as the basis of the HBEL, including tools to evaluate data quality, and methods for deriving HBEL values for data-poor compounds.  The presentation will also briefly describe useful online sources of toxicity data.
Ronald Brown | Toxicologist, former U.S. FDA (retired)
Safety Assessment of Extractables & Leachables for Single Use System
  • How to evaluate/use the Extractables/Leachables data from supplier or the CRO
  • How to obtain Toxicological/ Safety assessment data.
  • Tools for the Toxicological/Safety Assessment

Hovery Yin | Validation Services, Extractables/Leachables Project Specialist, Sartorius
Networking Break (sponsored by Milestone)
Session 7: E&L in Medical Devices
Application of E&L Studies in The Field of Medical Devices
This session will provide an overview and interpretation of the revised ISO 10993 Part 18.
Yong Shen | Senior Engineer, Shandong Quality Inspection Center For Medical Devices
Design and Case Sharing of E&L for Medical Devices/Materials - Based on NMPA and FDA Regulatory Requirements
Unknown E&L Screening Method Establishment and Its Application in The Biological Evaluation
As the publication and implementation of the new version of ISO 10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process in January 2020 as well as the notice of draft for comments of technical review guidelines for medical device unknown E&L evaluation method establishment and characterization from CMDE in June, the evaluation of chemical characterization and toxicological risk assessment combined with biocompatibility test results becomes a new trend in the biological safety evaluation of medical devices. How to treat the role of chemical characterization in the whole biological evaluation? What is the difference between known and unknown E&L study? All these questions are raised from medical device companies for product registration and launch. 
In order to have better understanding of the lasted trends of the regulations, the difference between known and unknown E&L study, the establishment unknown screening method and database as well as the application of unknown screening and toxicological risk assessment in the biological evaluation will be discussed according to the new CMDE guideline in this presentation.
Dongdi Sun | Director of Chemistry Laboratory, Medical Device Testing Center, WuXi AppTec (Suzhou) Co., Ltd
Networking Lunch
Utilization of Chemical Characterization to Support Issues on Standard Compliance
E&L Study for PFS (pre-filled syringe) System
Networking Break (sponsored by Milestone)
Session 8: From Theory to Practice: Experimental Designs for E&L Studies and Case Studies
Best Practice for The Experimental Designs on E&L Study, and Resonance between Device and Drug Packaging
Through this topic I would like to share some cases to present the best practice for the experimental designs on Extractables and Leachables study. In some domestic third-party laboratories they run the tests in a fixed protocol and didn't design the analysis in a scientific route. Extractables and Leachables study has its own contetnts rather than impurity analysis, but this concept has not fully recognized by local chemists yet. 
Through the second part I would like to present you there be some common requirement on chemical characterizations between medical devices and drug packaging, by introducing the lately released guidance by CMDE.
Cheney Lin | BD Director, Milestone
Quality Control and E&L Research of High Risk Drug Contact Material
-    Supervision and management of high risk drug contact material 
-    The standard of pharmaceutical packaging standard
-    Case study I of E&L research-vails
-    Case study II of E&L
Fangfang Zhang | Senior Engineer, Shanghai Food and Drug Packaging Material Control Center China
Session 9: Focus on Materials and Biomaterials
Nitrosamine Impurities in Drug Products – Risk Assessment of Elastomeric Components
Nitrosamine impurities have been in the regulatory spotlight since the Food and Drug Administration (FDA) announcement of a recall of some angiotensin II receptor blockers (ARBs) as “-sartan” drugs back in July 2018. Nitrosamine impurities are of concern because they are probable human carcinogens. Nitrosamines can come from different sources, e.g. contaminated equipment or reagents, or they can be formed through a reaction of precursors during manufacturing, handling, and storage. Regulatory agencies such as the FDA and European Medicines Agency have requested Marketing Authorisation Holders (MAHs) to conduct a risk assessment to determine the potential presence of nitrosamine impurities and the level if they are present. In China, a technical guideline related to nitrosamine impurities was released in May 2020, which includes a similar requirement.  

As one component in the vial packaging system/prefilled syringes for injectables, the elastomeric closure is always a concern due to its direct contact with drug. The first step in an overall risk assessment is the assessment an understanding of the potential level of extractable compounds in the elastomeric component. However, the level of these compounds found as leachables in the final drug product is more critical.
Lynn Yao | Scientific Affairs Manager, China , West Pharmaceutical Packaging (China) Co., Ltd.