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07:50 Registration and Welcome Coffee
08:20 Opening Address from the Chairman
08:30 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:
09:10 Speed Networking
09:50 Strategies for assessment of impurities and E&Ls.
Prof. Dr. Johannes Harleman
Independent Consultant, , Darmstadt, Germany
10:30 Morning coffee and networking break
11:00 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 Setting up effective E&L Studies.
14:25 Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration.
Sterile filters are ubiquitous in biopharmaceutical manufacturing processes. They are in direct contact with the process fluid, and the profiling of the extractables is of high importance, especially in process steps “close to patient” such as single-use final fill. The talk will compare and discuss the extractables profiles of sterilizing-grade 0.2 μm polyethersulfone membrane filter cartridges from different vendors. Pure ethanol and purified water were used as extraction media. Several orthogonal analytical techniques such as HS GCMS and GC-MS and LC-HRMS in combination with ICP-MS for single analyte detection and the sum parameters total organic carbon, nonvolatile residue, conductivity, and pH were used to obtain a most comprehensive extractables profile. Various extractables were found such as antioxidants and degradation products thereof, hydrocarbons, and processing aids. The identified compounds can all assigned to the materials of construction, such as plastic parts or membranes. Focus is given also on the challenges one encounters in Extractables screening studies for example in the analysis of hydrophilizing agents. A basic toxicological evaluation for material safety assessment will be presented showing the overall low risk of the extractables toward patient safety.
15:05 Afternoon coffee and networking break
15:35 Neat and Ready-to-use Calibrants for Extractables & Leachables Testing Methods
16:15 Risk Based approaches to Extractable and Leachable Study design.
16:55 Data Integrity.
17:35 Panel Discussion
18:15 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 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.
10:00 Morning coffee and networking break
10:30 The rubber formulation composition and its impact on extractables and leachables.
11:10 Extractables from Rubber Closures – Assessment and Control
Dr. Bettine Boltres,
Principal Scientific Affairs, Packaging & Delivery Systems, West Pharmaceutical Services Deutschland GmbH & Co KG, Eschweiler, Germany
12:00 Business lunch
13:00 Extractables and Leachables profiles from glass tubing and container made out of pharmaceutical glass
13:40 Adoption of standardized extractables datasets for single-use system qualification and risk assessment.
14:20 Errors in chromatographic screening
15:00 Chairman’s closing remarks and end of day two
15:10 Afternoon coffee and networking break
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