1) Regulations and relevant standards that used in the Medical Device E&L Research Institute;
2) Current status and challenges of E&L research on implantable interventional medical devices;
3) From the perspective of extractables and leachables, discussing and Case sharing on the biological performance of implantable interventional medical devices in animals
Dr. Xiaoliang Wang | Deputy Director, Safety Evaluation Center, Sichuan Insitute for Drug Control (Sichuan Testing Center of Medical Devices)

Dennis Jenke | Chief Executive Scientist, Triad Scientific Solutions

The new version of ISO10993-17 will be launched in September 2023. It is significantly different from the old version more than 20 years ago. This report will explain the principles and characteristics of the toxicological evaluation of the new version of device E&L as well as the differences and advantages compared with the old version.
Dr. Leshuai Zhang | Professor, Toxicologist, Soochow University

Before implementation of single use systems (SUS) in the production a risk assessment, with regards to leachables and safety risk to patients, is needed. Several manufactures/suppliers of SUS have been involved in the BioPhorum E&L SUS initiative, where a process for generation of extractables data on their SUS components are described. As a result suppliers are providing extractables data on their main SUS, which can then be used directly in the risk evaluation process at the pharmaceutical companies. However, many pharmaceutical companies experiences a challenging supply situation and may therefore need to qualify back-up systems/components in case of shortage. The presentation will discuss the dilemma of using SUS from suppliers without extraction data or knowledge on E&L.
Further the presentation will describe a case, where a SUS component for a new drug product filling setup was to be implemented and since supplier extraction data was unavailable, an in-house extraction study was carried out. Abundant, unknown extractables proved a major challenge since they appeared in the leachables study in concentrations above the defined acceptance criteria. In addition to the identification work done by Liquid Chromatography with Ultra-Violet and Mass Spectrometric detection (LCUVMS), the presentation will include considerations about the challenge in handling exceeding low analytical evaluation thresholds (AETs) resulting from use of SUS with biological drug products.
 
Carsten Worsøe | Principal Scientist Extractables and Leachables, Novo Nordisk

Long-term implantable polymeric devices require comprehensive chemical characterization studies. The first part to complete is an asymptotic extraction study, , which requires multi-method confirmation of how to determine the limit extraction level to be reached. The second part is to pay attention to the selection of simulation solvents, as unreasonable solvents can increase the list of extractable/leachable compounds, and the solvents need to be selected appropriately based on the risk of the device. The third part is to do a complete scan of leachables using comprehensive testing methods, the uncertainty factor is the most current regulatory concern. Finally, a toxicological assessment of the risky leachables should be done to evaluate the long-term risk of the device in vivo. The latest version of ISO 10993-17:2023, which has been significantly updated from the previous version, is used to draw conclusions on the toxicological evaluation of leachables
 
Chunxing Lin | Vice President, Milestone

Dongdi Sun | Director of Chemistry Laboratory, Medical Device Testing Center, WuXi AppTec (Suzhou) Co., Ltd

This topic will introduce the biocompatibility research of medical devices utilizing animal tissues and their derivatives/Tissue engineered medical products, including the following four aspects: Product Definition, Relevant Regulations and Standards in China, Research Protocol Design (such as sample preparation, biocompatibility tests, immunotoxicology, etc.) and Case Analysis (such as animal derived typeⅠcollagen plant, 3D printed bioceramic scaffolds, etc.)
Zhai Zhichen | Director of the IBMD-TC, Guangdong Institute of Advanced Biomaterials and Medical Devices, Testing Center

Large-Volume Parenteral has developed rapidly in recent years, especially the potential market for therapeutic or nutritional varieties. However, as the tremendously raise of medicine usage by different therapeutic approach, a series of potential problems in E&L study have also been triggered. Fulfillment of the AET requirement is the huge challenge what we are going to tackle at the current stage. Concentration is a very direct processing method for sample enrichment, we will discuss the current situation of common enrichment method for E&L analysis.
Xiaowei Wang | Analytical Scientist , Fresenius Medical Care

The extractables/leachables analysis is the most convenient and effective means in chemical characterization, and its main research steps include the determination of extraction conditions, the establishment of AET, the development and verification of analytical methods, and the qualitative/quantitative extractables/leachables. Extraction conditions are the key to affect the test results. The report will review the extraction methods of common medical devices, and compare the effects of different extraction conditions on the qualitative and quantitative results of extractables/leachables.
Wang Heng | Senior Technical Director, WEIPU Medical Devices Division

Jan Baeten | Sr. Scientist – Technical Advisor, Nelson Labs

Moderator:
Haiyan Hong, Analytical & QC & Development manager, Asia at Saint-Gobain
Panelist: Wenjing Zhao, Biocompatibility Technical Manager at Fresenius
Prof. Zhang Leshuai, Professor, Soochow University
Carsten Worsøe, Principal Scientist Extractables and Leachables, Novo Nordisk Carsten Worsøe