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Day One - 26 June 2025 THU Day Two - 27 June 2025 FRI
Registration and Welcome
Registration
Opening Remarks
Session: Meeting Regulatory Requirements
Updates on the Finalized System Suitability Standards Proposal from USP for the analysis of Organic Extractables & Leachables.
An E&L study for pharmaceutical drug products typically follows USP <1663> and <1664> for Extractables and Leachables associated with pharmaceutical packaging/delivery systems. Key elements for the success of E&L study are to ensure the pre-requisites like accurate system set up, consistent column performance, and stable and sensitive detector response prior to the analysis. Lack of harmonized system suitability procedures and practices creating challenges for the industry.
USP has published a stimuli article (49(4), July 2023) and provided the experimental conditions and set of standards for the most used chromatographic systems (GC-MS, HS GC-MS, LC-MS-APCI and LC-MS ESI) for the analysis of organic extractables and leachables. Several comments were received from the E&L experts and other stakeholders on the technical aspects as well as the usefulness of this proposal. In general, the comments were positive, and the consensus was to modify the set of standards appropriately and conduct a round robin study by various labs to evaluate a wider acceptability.
This presentation will overview the USP’s finalized System Suitability Standards based on a round robin study, obtaining feedback and appropriately modifying certain compounds and experimental parameters suitable for organic E&L analysis using the hyphenated chromatographic methods mentioned above. The talk will cover updates on revised list of compounds, methodologies, example chromatograms and the proposed second stimuli article as well as next steps to introduce these 4 sets of standard mixes for global stakeholder useAn E&L study for pharmaceutical drug products typically follows USP <1663> and <1664> for Extractables and Leachables associated with pharmaceutical packaging/delivery systems. Key elements for the success of E&L study are to ensure the pre-requisites like accurate system set up, consistent column performance, and stable and sensitive detector response prior to the analysis. Lack of harmonized system suitability procedures and practices creating challenges for the industry.
USP has published a stimuli article (49(4), July 2023) and provided the experimental conditions and set of standards for the most used chromatographic systems (GC-MS, HS GC-MS, LC-MS-APCI and LC-MS ESI) for the analysis of organic extractables and leachables. Several comments were received from the E&L experts and other stakeholders on the technical aspects as well as the usefulness of this proposal. In general, the comments were positive, and the consensus was to modify the set of standards appropriately and conduct a round robin study by various labs to evaluate a wider acceptability.
This presentation will overview the USP’s finalized System Suitability Standards based on a round robin study, obtaining feedback and appropriately modifying certain compounds and experimental parameters suitable for organic E&L analysis using the hyphenated chromatographic methods mentioned above. The talk will cover updates on revised list of compounds, methodologies, example chromatograms and the proposed second stimuli article as well as next steps to introduce these 4 sets of standard mixes for global stakeholder use.

Ravi Kiran Kaja, Ph. D., Senior Principal Scientist, Complex Generics- Science, General Chapters, United States Pharmacopeia (USP)
 
G. Prabhakar Reddy | Director of Pharmaceutical Sciences General Chapters & Complex Generics, USP
Update on equivalence research and assessment for rubber closures
Container closure system is a crucial component of drug products. Changes in container closure system may have an impact on the quality, stability, and safety of drug product. Currently, regulatory agencies such as the NMPA, FDA, EMA, and ICH have issued regulations and guidelines specifying requirements for changes in container closure system. However, there are few reports on the equivalence research for packaging changes in marketed drugs. This topic focuses on the equivalence research of rubber closures, using multiple technical methods such as RS, IC, TGA-GC-MS, SEM-EDS and LC-MS. The research comprehensively analyzes the formulation system (inorganic fillers, vulcanization system, halide types, etc.), extractables, inorganic elements, and related physicochemical properties of 13 batches of halogenated butyl rubber stoppers for injection. It establishes the framework and testing methods for rubber closures equivalence research. The results of this research can be applied in evaluating for changes in container closure system and providing scientific evidence for new packaging components to meet their intended use.
  • Background of research on equivalence of rubber closures
  • Research practice on equivalence of rubber closures
  • Summary and discussion on the equivalence of rubber closures

Yan Jiang | Director of Packaging Materials and Pharmaceutical Excipients Testing and Research Department , Sichuan Institute for Drug Control
Regulatory Requirements and Study Strategies for E&L Studies in Dual China-US Submissions
Abstract coming soon…
 
Chunxin Lin | Vice President, Milestone
Tea Break and Networking
Session: Designing E&L studies in right approaches
Good E&L design of combination products with liquid drugs for global registration
  • Regulatory requirements and Agency expectations
  • Challenge and case studies
  • Summary and discussion

Wenjing Zhao | Biocompatibility Technical Manager, Fresenius
Design Principles for Extractables Studies of Combination Products
Combination products became more prominent in recent decades as modern healthcare combines pharmaceuticals, medical devices and biologics. This session provides an introduction on the diversity of combination products and an overview of the standards and guidance that apply to them. Next, the session looks at an example combination product and the proposed ‘ideal’ extractables study design for the product which require a combination of approaches.
  • Combination product diversity
  • Which standards apply?
  • Example combination product
  • "Ideal" study design
  • Summary & take-home messages

Jia Min Boo | Technology Manager, AP , West Pharmaceutical Services Singapore Pte Ltd
Networking Lunch
Session: Advanced Analytical Methods
Development of dispersive liquid-liquid microextraction (DLLME) method for the extractable study of medical devices
Abstract coming soon…
 
Dongdi Sun | Biology Lab Director, Medical Device Testing Center, WuXi AppTec
Simultaneous targeted and non-targeted PFAS screening as part of the extractables screening for pharmaceutical packaging, manufacturing components and medical device materials by a LC-HRMS method
The “forever chemicals” Per- and polyfluoroalkyl substances (PFAS) are known for their persistence in the environment and in the human body, leading to potential health issues. Regulatory agencies like the FDA and EPA have set stringent guidelines and limits for PFAS in various products and matrices. However, there is still no regulatory guidance on PFAS levels present in pharmaceutical products and medical devices, which could compromise product safety and efficacy for drug products and devices. As such, medical device and pharmaceutical manufacturers should be proactive by staying up to date with current and future regulation and develop risk mitigation strategies to avoid costly product recall or delays in approvals. To that end, having the ability to detect and quantitate PFAS in various pharmaceutical packaging and medical device materials is essential. In this presentation, we report an LC-HRMS based concurrent targeted and untargeted detection of PFAS that could be extracted from manufacturing components and containers as part of extractables screening. Sensitive detection of multiple PFAS of interest at sub-ppb levels could be established using Full Scan data from an Orbitrap system, while collecting data dependent MS2 data for unknown identification of potential PFAS compounds within the same injection. In a case study, targeted PFAS could be detected at sub-ppb levels from Fluorinated Ethylene Propylene (FEP) bottles and tubing, and additional PFAS were revealed from the non-targeted analysis following common E&L practices.
  • Combined targeted quantitation and non-targeted screening for PFAS during a single analysis.
  • One LC-HRMS method providing both PFAS-specific and general extractables screening.
  • Targeted analysis of a list of PFAS to yield unequivocal identification and quantification down to sub-ppb levels.
  • Non-targeted analysis to reveal additional PFAS contaminants in the sample extracts that can be quantified using surrogate standards.

Dujuan Lu, Ph.D. | Manager/Global Leader-E&L, SGS Health Sciences
Managing New Requirements Alongside USP 665 Compliance
The goal will be to present how to effectively handle additional new requirements in parallel with USP 665 (including USP 661.1, 661.2, 662, 382, 383, and EP 4.2.35) and transition from strategy to a fully implemented and operational USP 665 compliance program.
Strategy Program: From Presentation to Implementation:
  • Key Learnings: Insights gained from the transition of the strategy program from its presentation at the previous conference to its current implementation and usage.
  • Key Difficulties Faced During Implementation: Challenges encountered while putting the strategy program into practice.
  • Management of Labs and Testing: Approaches and methods used to manage laboratory operations and testing procedures.
  • Workload Management: Strategies employed to handle and distribute workload effectively.
  • Digitalization as a Key Element: The role of digitalization in enhancing the efficiency and effectiveness of the strategy program.
  • Managing Additional Requirements in Terms of E&L: How to address and incorporate additional requirements related to Extractables and Leachables (E&L).
  • Additional Testing for Cured Silicone Elastomers (USP 383): Specific testing protocols for cured silicone elastomers as per USP 383 standards.
  • Plastic Packaging Systems vs. Physicochemical Testing (USP 661.2): Comparison between plastic packaging systems and physicochemical testing requirements outlined in USP 661.2.
  • Glass Container Requirements in Terms of Extractables (Future USP 660): Anticipated requirements for glass containers concerning extractables, as per the upcoming USP 660 standards.
  • Metallic Packaging Systems (USP 662): Standards and testing requirements for metallic packaging systems according to USP 662.
Etienne Michel, Global Quality Expert at GSK Vaccines &
 
Marine Lepoutre | Global Subject Matter Expert, GSK Vaccines
Networking tea break
Session: Toxicological Assessment and Risk Management
Harmonization of read-across methodology for drug substance extractables and leachables (E&Ls)
  • The purpose was to develop a read-across methodology for extractables and leachables to derive health based exposure limits for compounds with limited toxicology data
  • The methodology was based on responses from pharmaceutical companies surveyed on current E&L practices and read-across approaches, as well read-across literature from other industries
  • Oral to parenteral bioavailability factors based on phys-chem properties were proposed for compounds lacking experimental and/or predicted bioavailability

Anders Burild | Specialist, PhD Toxicology Development Projects, Novo Nordisk
Risk assessment of Extractables and Leachables
Abstract coming soon...
 
Dr. Leshuai Zhang | Professor, Toxicologist, Soochow University
End of Day One
Session: Practical issues associated with E&L
The risk of unmonitored leachables in hospital pharmacy compounding due to the off-label use of plastic primary packaging: A cause for concern?
Hospital pharmacies hold a critical and unique position in healthcare by regularly batch compounding drug products (DPs) to meet hospital demands and address specific clinical needs. A key challenge is the off-label use of plastic primary packaging, due to a lack of awareness, cost constraints, and inadequate regulation. When primary packaging is not appropriately selected or subjected to risk assessments, harmful leachable compounds may be released, posing a serious threat to patient safety. Therefore, heightened awareness, stringent assessments, and regulatory guidance are essential to ensure safe compounding practices worldwide.
 
  • Hospital pharmacies’ key asset is compounding drug products (DPs) to ensure continuous patient treatment.
  • Compounding is done through nominal preparation, which involves short-term use tailored for individual patients, based on prescription, and batch production, which is a larger-scale preparation often lasting up to a year, simplifying intravenous services.
  • A major challenge in batch compounding is the off-label use of plastic primary packaging, which can release harmful, and unmonitored leachable compounds, endangering patient safety.
  • Key causes include a lack of awareness, financial constraints and inadequate regulations.
  • Solutions include promoting awareness programs involving healthcare professionals, industry leaders, and regulators, encouraging analytical and toxicological assessments to ensure patient safety during DP administration, and finally advocating for proper use and regulation of plastic primary packaging in hospital compounding.
  • This global issue, including Asia, demands urgent action to safeguard patient safety.

William Bello | Analytical Pharmacist, Lausanne University Hospital
Session: Challenges and technical advances on E&L Analysis
Extractables Assessment of Material Changes: Leveraging Chemical Analysis and Smart Tools
  • Comparison of USP<665> vs Sartorius Extractables Approach(100% Ethanol) in context material characterization and the case of PP-Change for gamma-filters
  • Sartorius approach to assess E/L risk related to the change by use of substance-specific PDE values or general TTC values..
  • Sartorius Extractables Simulator 2.0(ExSim 2.0)

Daniel Canton | Manager of Validation Lab, Sartorius
Practical issues associated with E&L testing
Abstract coming soon…
 
Manojkumar V Ph.D | Senior Team Lead, Pfizer
Networking tea break
Session: Simply the approaches and standardized protocols
[PANEL] Simply the approaches of E&L studies and risk assessments
  • Standardized protocols
  • Benefits and challenges
  • Case studies

Moderator
William Bello, Analytical Pharmacist at Lausanne University Hospital

Panelists
  • Daniel Canton, Manager of Validation Lab at Sartorius
  • Yan Jiang, Director of Packaging Materials and Pharmaceutical Excipients Testing and Research Department at Sichuan Institute for Drug Control
  • Dujuan Lu, E&L Global Leader at SGS
  • Manojkumar Varada Ph.D., Senior Team Lead, Medicinal Sciences – Pharmaceutical Sciences Small Molecule at Pfizer Healthcare India
Networking Lunch
End of the Conference