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Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
07:50 Registration and Welcome Coffee
08:30 Opening Address from the Chairman
08:40 USP <665> draft standard: A rational risk-based approach to characterization of polymeric biopharmaceutical manufacturing systems.
USP <665> draft will be the first standard for characterization of specifically single-use systems (SUS) used in manufacturing. In this session we will discuss:
09:20 Speed Networking
10:00 Strategies for assessment of impurities and E&Ls.
10:40 Morning coffee and networking break
11:10 Safety assessment of extractables/leachables: Challenges with different administration routes.
11:40 Toxicological assessment of non-genotoxic E&L.
12:20 Challenges and pitfalls during E&L studies and how to handle them.
For patient safety reasons a precise knowledge about potential drug impurities is essential. With increasing complexity of container closure systems and single use process equipment the risk of leachables being introduced as real drug impurities increases significantly. Authorities are extensively focusing on determination of leachables present in the real drug matrix which increases the analytical effort and complicates data interpretation.
According to general guidelines the E&L studies are commonly divided into different parts:
During this presentation we will focus on the problems which may occur when extractables or leachables above the analytical evaluation threshold are detected during the different steps. Several case studies will be presented. Content:
12:45 Business lunch
13:45 RESERVED FOR SPONSOR
14:10 Setting up effective E&L Studies: extraction and right conditions selection, leachable study monitoring and compounds selection, leachable study design.
14:50 Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration.
15:30 Afternoon coffee and networking break
16:00 Data Integrity.
16:40 Case Study #10
17:20 Panel Discussion
17:50 Chairman’s closing remarks and end of day one
19:00 Business dinner
08:00 Registration and Welcome Coffee
08:30 Opening Address from the Chairman
08:40 Extractables and Leachables challenges of for prefilled syringes
09:20 Case Study #2
10:00 Morning coffee and networking break
10:30 The rubber formulation composition and its impact on extractables and leachables.
11:10 Leachables strategies for finished biopharmaceuticals.
Extractables and leachables are product-related impurities that result from product contact with components such as gaskets, stoppers, storage bags, cartridges, and prefilled syringes that are used for processing, storage, and/or delivery of biopharmaceuticals.
Leachables are of concern for patients due to potential effects on product quality and safety. It is possible that such an impurity could directly impact the patient or indirectly impact the patient by interacting with the protein by chemical reactions. Adducts and leachables may or may not be detected as product-related impurities in leachables screening stability studies depending on the rigor of the analytical program.
The need for the development of a thorough and holistic extractable and leachable program based on risk assessment, review of existing literature, and consolidation of industry best practices is discussed. Risk mitigation strategies for an extractable-leachable program must be divided into different stages. The integration of analytical activities with health-based risk-assessment information into the design of an extractable-leachable program is highlighted.
12:00 Business lunch
13:00 To Be Announced
Dr. Bettine Boltres,
Principal Scientific Affairs, Packaging & Delivery Systems, West Pharmaceutical Services Deutschland GmbH & Co KG, Eschweiler, Germany
13:40 Adoption of standardized extractables datasets for single-use system qualification and risk assessment.
14:20 Afternoon coffee and networking break
14:50 Case Study #7
15:30 Case Study #8
16:10 Chairman’s closing remarks and end of day two
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chaired a panel discussion on the digitisation of clinical trials and next gen injectable devices, with speakers from Novartis, Roche, Janssen, Sanofi, SHL Group and Corvus Device.