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Industry guidance on container closure integrity strategies for difficult-to-test parenteral products (DTPs) 关于难以测试的无菌注射剂（DTPs）的容器密闭完整性策略的行业指导 Wuchner, Klaus; Riesop, David; Huon, Carine; Mudumala, Prudvi Raj; Steffen, Jean-Sebastien; Kuhn, Sebastian M.; Mayer, Tobias; Rass, Sophia; Neuhold, Karen; Spreng, Ben; Hebting, Henri 分享 收藏
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Monitoring of Visible Particles in Parenteral Products by Manual Visual Inspection-Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility Mazaheri, Maryam; Saggu, Miguel; Wuchner, Klaus; Koulov, Atanas V.; Nikels, Felix; Das, Tapan K.; Chalus, Pascal; Cash, Patricia W.; Finkler, Christof; Levitskaya-Seaman, Sophia V.; Case, John; Parsons, Jonny; Gonzalez, Kristen 分享 收藏
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An Interlaboratory Study to Identify Potential Visible Protein-Like Particle Standards Telikepalli, Srivalli N.; Carrier, Michael J.; Ripple, Dean C.; Barnett, Greg; Bhirde, Ashwinkumar; Bolton, Donna; Bou-Assaf, George M.; Ferrari, Erica; Leigh, Scott; Levitskaya-Seaman, Sophia; Menzen, Tim; Nikels, Felix; Riley, Anna; Saggu, Miguel; Sahni, Neha; Vernooij, Eric; Wuchner, Klaus 分享 收藏
Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future Wuchner, Klaus; Yi, Linda; Chery, Cyrille; Nikels, Felix; Junge, Friederike; Crotts, George; Rinaldi, Gianluca; Starkey, Jason A.; Bechtold-Peters, Karoline; Shuman, Melissa; Leiss, Michael; Jahn, Michael; Garidel, Patrick; de Ruiter, Rien; Richer, Sarah M.; Cao, Shawn; Peuker, Sebastian; Huille, Sylvain; Wang, Tingting; Le Brun, Virginie 分享 收藏
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Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates Wuchner, Klaus; Yi, Linda; Chery, Cyrille; Nikels, Felix; Junge, Friederike; Crotts, George; Rinaldi, Gianluca; Starkey, Jason A.; Bechtold-Peters, Karoline; Shuman, Melissa; Leiss, Michael; Jahn, Michael; Garidel, Patrick; de Ruiter, Rien; Richer, Sarah M.; Cao, Shawn; Peuker, Sebastian; Huille, Sylvain; Wang, Tingting; Le Brun, Virginie 分享 收藏
Particles in Biopharmaceutical Formulations, Part 2: An Update on Analytical Techniques and Applications for Therapeutic Proteins, Viruses, Vaccines and Cells Roesch, Alexandra; Zoells, Sarah; Stadler, Daniela; Helbig, Constanze; Wuchner, Klaus; Kersten, Gideon; Hawe, Andrea; Jiskoot, Wim; Menzen, Tim 分享 收藏
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A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products Hubert, Mario; Yang, Dennis T.; Kwok, Stanley C.; Rios, Anacelia; Das, Tapan K.; Patel, Ankit; Wuchner, Klaus; Antochshuk, Valentyn; Junge, Friederike; Bou-Assaf, George M.; Cao, Shawn; Saggu, Miguel; Montrond, Luis; Afonina, Nataliya; Kolhe, Parag; Loladze, Vakhtang; Narhi, Linda 分享 收藏
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