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Agenda

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Registration and Welcome
Registration and refreshments
Welcome & Opening remarks
Session 1: Perspectives from Pharma and Bio-Tech Companies
Future Challenges to Extractables and Leachables Assessment
The landscape for E&L assessment has changed over the past two decades. We now have a better understanding of E&L and improved procedures for analyses. The field is still evolving. Currently updates to regulations and standards are ongoing that will influence E&L assessment in the future. The adoption of ICH Q3E will harmonize the various recommendations, sometimes at odds, that exist currently. Re-defining basic terms such as SCT, AET, UF, etc. and harmonized safety thresholds will be implemented. Changes to USP<661>into two chapters USP<661.1> and <661.2> will influence future E&L assessments. Concepts such as migration modelling will be more common. All these changes that will affect E&L will be discussed.
 
Atish Sen, PhD | Director, Analytical Sciences Inhalation Product Development, AstraZeneca
Identification and quantification of extractables and leachables in laminated film and pouches for pharmaceutical packaging
Determination and toxicological evaluation of N-Nitrosamines impurities (NAs) from elastomers in biopharmaceutical
N-nitrosamines and similar structural compounds should be paid attention to in elastomer based on domestic and foreign regulations. The migration of nitrosamines from medical packaging elastomers may lead to the presence of nitrosamines in the drug products resulted in health risk. Therefore, it is urgently important to develop a distinctive method to detect nitrosamines from elastomers in pharmaceutical primary packaging. However, no analytical method is provided for biopharmaceuticals. In present work, a salting-out liquid-liquid extraction (SALLE) coupled with liquid chromatography-mass spectrometry (LC-MS) method was firstly presented for the quantification of 13 nitrosamine contaminations in antibody drugs. The method showcased excellent linearity over the range of 0.5-5.0 μg/L with LOQ (limit of quantitation) of 0.5 μg/L for targeted nitrosamines. Moreover, this method was demonstrated to be accurate (recovery in a range of 75.4-114.7%) and precise (RSD ≤ 13.2%) for 13 nitrosamines using spiked samples. In conclusion, we provide a sensitive and reliable method for nitrosamine estimations to ensure the safety of biological medications.
Yangguo Xie | Senior Supervisor E&L Formulation Analysis, Shanghai Henlius Biotechnology Co., Ltd
Networking break
Session 2: E&L for CCS and SUS
Technical Essentials for Extractables and Leachables Study in Single-Use Systems
This speech will introduce the necessity of extractables and leachables (E&L) research from the sources and regulatory requirements of single-use systems (SUS), and focus on the overall process and technical difficulties of E&L research, including risk assessment, extractables Biochemical studies, toxicological assessments, simulated production studies, and the practice of E&L with specific cases.
In addition, it will also discuss how to apply the supplier's research data, in order to provide advice and help to the final preparation manufacturer.
Finally, the future trend of extractables and leachables research of SUS is also prospected.
Hong Chang | Technical Expert of Compatibility Research, Weipu
E&L Research approach introduction and discussion
This topic will focus on the introduction and discussion of extractable research approach in industry. By a SUT case, compare the data in different extractable research approach and Leachable to help customer get more understanding E&L Research and do the E&L Research for SUT.
1. Extractable research approach
2. Leachable research approach
3. Case study for a SUT
Zhaodi Zhang | E&L Lab Manger , Pall Validation
Lunch break
Theory and Practice of Sartorius Extractables Simulator(ExSim) – Simplifying SUS E&L study through in-silico modeling
  • How to Use Extractables Data from SUS Supplier    
  • What is Sartorius Extractables Simulator | ExSim    
  • Why Need Sartorius Extractables Assessment         

Hovery Yin | Manager of Project Management,Filtration/SUS, Confidence® Validation Services, Sartorius
A Reasoned Approach to Leachables to Extractables Correlations
Logically there should a strong correlation between the list and amounts of leachables and the list and
amounts of extractables. Such a correlation is fortuitous as it serves three useful purposes: (1) verifies the rigor and completeness of the leachables profiling activity (as one does not want to miss leachables during a leachables migration study), (2) allows extractables testing to do the work of leachables testing in activities such as change control (as managing change by testing incoming items for extractables may be simpler and more efficient than testing manufactured drug products for leachables), and (3) supports the premise that extractables data can forecast leachables. However, extractables and leachables correlations can be poor, suggesting (perhaps) that E&L testing was not being practiced with the expected and necessary high level of scientific competence.
 
In this presentation we review of the underlying aspects of study design and implementation that must be recognized and controlled to enable the effective correlation of leachables to extractables and we consider the logical, and perhaps not so logical, reasons why even under the most equitable and well-controlled experimental circumstances leachables may not be correlatable to extractables.
Additionally, the presenter will address concepts associated with the exhaustive extraction of medical devices.
Dennis Jenke | Chief Executive Scientist, Triad Scientific Solutions
Session 3: International Applications – E&L focusing
FDA assessment concerns in E&L testing studies
  • Regulatory environment and relevant regulations
  • Interpretation of FDA assessment concerns
  • The cases of E&L studies for FDA drug application

Weixing Yang | CTO, STANDARD BIO-PHARMACEUTICAL
Networking tea break
Developing effective communication to benefit E&L studies
Extractable and leachable studies are often complex and time-consuming, with risk of unexpected issues, budget overspend and late delivery. Effective communication can reduce this risk, helping to prepare a robust study plan and creating more control over the project.
 
In this webinar we explore the benefits of taking time and consideration for proactive communication throughout the lifecycle of the study, from design to delivery. We show how early planning of communication channels and assessment of stakeholders ensures that the right people are involved at the right time. This promotes quick decision making, smooth delivery of the data, and potential cost saving by eliminating unnecessary testing, reduction of errors and scope creep.
Ewa Miaskiewicz | Project Manager, Smithers
Panel Discussion: toxicological risk assessment: TTC
1. Is it regulatory mandatory to conduct safety assessment after extractables test/leachables test?
2. Currently, the thresholds for safety assessment include SCT, QT, TTC threshold of ICH M7, TTC value of Cramer classification, etc. Which threshold should be used for safety assessment of injections?
3. Does the TTC threshold of ICH M7 and Cramer's TTC threshold need to be converted by certain factors when used for injection or inhalation? Because Cramer and ICH M7 data are mostly based on oral.
4. When multiple extractables/leachables are detected, should the Individual Impurity threshold or multiple impurity threshold of TTC be used for evaluation? Is it possible to pass the declaration if the Individual impurity  passes the threshold, but the sum of the Multiple Impurities fail the thresholds?
5. Can you give some advice on the use of QT threshold for injections? How to confirm which substances can use QT.

Panel Moderator: Hong Haiyan, Analytical & QC & Development manager, Asia, Saint-Gobain
Panelists: Hovery Yin, Manager of Project Management, Filtration/SUS , Sartorius
                 Zhang Leshuai, Toxicologist, Professor, Soochow University
                 Xu Xueping, Toxicologist, Wuxi AppTec
                 Yangguo Xie, Senior Supervisor E&L Formulation Analysis, Henlius Biotechnology
 
End of Day one
Registration and Welcome
Registration and refreshments
Welcome & Opening remarks
Session 4: Toxicologist and Risk Assessment
Update on ELSIE Framework for Sensitization Assessment of E & Ls and Practical Application
The ELSIE Knowledge Base: A Novel Research Tool to Advance Collaboration on Safety and Extractables Evaluation
The Extractables and Leachables Safety Information Exchange (ELSIE) is a consortium of bio/pharmaceutical and medical device companies with the aim of sharing knowledge and information on and advancing the science and regulation of leachables and materials quality. ELSIE recently launched its "Knowledge Base" (KB), a database designed in consultation with subject matter experts to share and store safety and extractable study data and assist experts and nonexperts in understanding key aspects of E&L evaluation. We will present the technical capabilities and design of the KB with an invitation to the community to include their extractable and safety data in the KB.
James M. Vergis, Ph.D. | Director Science, Research, & Innovation, ELSIE Secretariat
Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTC) for Parenteral Extractables and Leachables
The threshold of toxicological concern (TTC), i.e., the dose of a compound lacking sufficient experimental toxicity data that is unlikely to result in an adverse health effect in humans, is important for evaluating extractables and leachables (E&Ls) as it guides analytical testing and minimizes the use of animal studies. The ELSIE consortium derived duration-based, non-mutagenic TTCs for parenteral extractables and leachables substances.  This presentation will first provide a brief background on the ELSIE risk management framework and on applications of the TTC concept.  The majority of the presentation will focus on the process for the TTC derivations, including an overview of the ELSIE database, data evaluated to determine the parenteral point of departure (PPOD), and application of adjustment factors. 
Melisa Masuda-Herrera | Senior Associate Scientist, Gilead Sciences
Networking tea break
Session 5: Challenges and Technical advances on E&L Analysis
Application of Mass Spectrometer in the analysis of Packaging Material Extractables and Leachables
(1) The application of Qtrap® mass spectrometer in the quantitative and qualitative applications of E&L
(2) The application of QTOF high resolution mass spectrometer in the targeted and non-targeted screening and quantitative of E&L
Xiaoyuan Shi | Application Specialist, SCIEX
Session 6: E&L Study for Medical Devices - hearing from Brand Owners and CROs
Application of biological evaluation within a risk analysis process for the implantable devices
With the publication of ISO 10993-1:2018 and GB/T 16886.1-2022, regulatory agencies have paid more attention to the toxicological risk assessment of E&L in medical devices. The information of chemical characterization and toxicological risk assessment can be leveraged in biological risk endpoints to evaluate product safety. This topic shares the testing and evaluation thoughts on implantable medical devices biological evaluation process from the aspects of biological evaluation standards update, toxicological risk assessment, and specific project cases.
Xueping Xu | MS, DABT, ERT, DCST, Wuxi AppTec
E/L Studies for Container Closure Systems of Medical Devices
The compatibility of medical devices and their container closure systems has received increasing attention from regulatory agencies and medical device manufacturers are required to conduct compatibility studies while submitting applications. This presentation will illustrate general considerations for the design of E/L studies of Container Closure Systems for Medical Devices. And case studies will be presented to discuss the differences between E/L studies of Container Closure Systems for Medical Devices and drug products.
Xiaoxia Ye | Senior Research Manager, Huadong Medicine
Lunch break
Chemical characterization in Medical Devices: Analytical Challenges and Case Studies
Identification and quantification of extractables and leachables, typically trace level analytes, is a regulatory expectation intended to ensure consumer safety.
Mass spectrometry and related techniques have played a significant role in the analysis of extractables and leachables.
In this presentation the elements of extractables studies will be discussed and will provide an overview of the current practices, analytical challenges, and emerging practices that may be adopted on a wider scale in the future. This presentation will also share the cases of chemical characterization of medical devices.
Yan An | Senior Scientist, Baxter Healthcare Cor.
Case sharing of chemical characterization application in the whole life cycle of medical devices
  • Brief introduction to the application of chemical characterization
  • case study

Wenjing Zhao | Sr scientist, Medtronic Technology Center – Greater China
Networking tea break
E&L study of respiratory air circulate medical devices
The ISO18562 series of standards are biological evaluation standards for respiratory products. These standards were released in 2017. At present, various regional regulatory agencies require related products to meet the above standards. ISO18562-1 is the overall framework standard for biological evaluation of respiratory products, and ISO18562-2, ISO18562-3, and ISO18562-4 are specific test standards. Among them, ISO18562-4 is the test standard for chemical characterization of leachables in condensate, and ISO 10993-18 is also the test standard for chemical characterization of equipment. We will focus on ISO18562- 4. Similarities and differences between ISO 10993-18 and ISO 10993-18 on E&L testing requirements, and share relevant cases of E&L testing and biological evaluation of breathing air circuit devices with you.
Chao Yang | Biological Evaluation Senior Engineer , Mindray
E&L Study of Prefilled Syringes
  • Regulatory requirements for prefilled syringes
  • E&L test design of components of prefilled syringes
  • Effects of different sterilization methods on the E&L study of prefilled syringes
  • Case Studies

Diandian Wang | R&D project leader, Hualan
End of the conference