visible particles from polysorbate degradation...usp visible particulates in injections – manual...
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Visible Particles from Polysorbate DegradationCases & Perspectives
Particles…
• represent an obligatory cQA for parenteral products
• are often a focus topic in audits and inspections
• are still the major reason for product recalls
• aspiration of zero visible particles is desirable, but unrealistic
Particles & Parenterals – not best friends
CMC Strategy Forum 2020/Washington - Visible Particles from Polysorbate Degradation - Felix Nikels 2Jan 27, 2020
• Standardized procedure: unaided human eye, light box, controlled light intensity (2000 – 3750 lx)
• Analysis upon gentle agitation (e.g. swirling)
• Well trained operators: – Periodic eyesight tests– Initial and continuous training – Performance qualification – Periodic performance control
USP <790> Visible Particulates in Injections – Manual Visual Inspection
CMC Strategy Forum 2020/Washington - Visible Particles from Polysorbate Degradation - Felix Nikels 3Jan 27, 2020
Ph. Eur. 2.9.20. “Particulate Contamination: Visible Particles”
Issue: No clear and harmonized definition of visibility available
Visual Inspection – Process Flow Scheme for Liquid Products
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Case study:Visible Particles in Biopharmaceutical Development Products
Case Study: Visible Particles in Biopharmaceutical Development Products
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Case Study: Particle Forensics – Morphology & Elemental Composition
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Case Study: Particle Forensics – Chemical Composition
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Case Study: Source of Free Fatty Acids – most likely PS20
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Case Study: Root Cause within the Manufacturing Process?
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Case Study: Mechanism of PS20 Degradation
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Case Study: Visible Particles in Biopharmaceutical Development Products
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Ingrid AuernhammerFlorian BaizMartin DassThomas EhrmannBeate EyrichCornelia GappPatrick GaridelJulia Groß-RotherFelix Halbach
Peter HappersbergerSilke HövelWerner KlicheMarius LöfflerTheresa MüllerDagmar RädelKatrin ReinhardtMarkus RieggerThomas Schwab
Maik VeeldersPeter WanjaTill WengerRobert WildJustine Witosch
and many more…
Acknowledgements
CMC Strategy Forum 2020/Washington - Visible Particles from Polysorbate Degradation - Felix Nikels 13Jan 27, 2020
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2019