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Key elements of bioanalytical method validation for small molecules 由 Surendra K. Bansal, Anthony J. DeStefano

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Human cell culture process capability: a comparison of manual and automated production 由 Yang Liu, Paul Hourd, Amit Chandra, David Williams

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Development and Validation of a Rapid Turbidimetric Assay to Determine the Potency of Cefuroxime Sodium in Powder for Dissolution for Injection 由 Daniela Cristine Mascia Vieira, Thalita M. Fiúza, Hérida Regina Nunes Salgado

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Quality by Design I: Application of Failure Mode Effect Analysis (FMEA) and Plackett–Burman Design of Experiments in the Identification of “Main Factors” in the Formulation and Pro... 由 Raafat Fahmy, Ravikanth Kona, Ramesh Dandu, Walter Xie, Gregg Claycamp, Stephen W. Hoag

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Cell culture processes for monoclonal antibody production 由 Feng Li, Natarajan Vijayasankaran, Amy Shen, Róbert Kiss, Ashraf Amanullah

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Pharmaceutical product development: A quality by design approach 由 Javed Ali, K. Pramod, MAbu Tahir, Naseem A. Charoo, ShahidH Ansari

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Application of quality by design in the current drug development 由 Lan Zhang, Shirui Mao

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A comprehensive approach to qualify and validate the essential parameters of an in vitro release test (IVRT) method for acyclovir cream, 5% 由 Katrin Tiffner, Isadore Kanfer, Thomas Augustin, Reingard Raml, Sam G. Raney, Frank Sinner

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Model uncertainty-based evaluation of process strategies during scale-up of biopharmaceutical processes 由 Johannes Möller, Tanja Hernández Rodríguez, Jan Müller, Lukas Arndt, Kim B. Kuchemüller, Björn Frahm, Regine Eibl, Dieter Eibl, Ralf Pörtner

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Ex vivo-expanded highly pure ABCB5+ mesenchymal stromal cells as Good Manufacturing Practice-compliant autologous advanced therapy medicinal product for clinical use: process valid... 由 Andreas Kerstan, Elke Niebergall‐Roth, Jasmina Esterlechner, Hannes M. Schröder, Martin Gasser, Ana Maria Waaga-Gasser, Matthias Goebeler, Katrin Rak, Philipp Schrüfer, Sabrina Endres, Petra Hagenbusch, Korinna Kraft, Kathrin Dieter, Seda Ballikaya, Nicole Stemler, Samar Sadeghi, Nils Tappenbeck, Gëorge F. Murphy, Dennis P. Orgill, Natasha Y. Frank, Christoph Ganss, Karin Scharffetter‐­Kochanek, Markus H. Frank, Mark A. Kluth

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A Fully Integrated Online Platform For Real Time Monitoring Of Multiple Product Quality Attributes In Biopharmaceutical Processes For Monoclonal Antibody Therapeutics 由 Yang Liu, Chi Zhang, Jiangchao Chen, Janice Fernandez, Pragna Vellala, Tanmay A. Kulkarni, Isaiah Aguilar, Diana Ritz, Kevin Lan, Pramthesh Patel, Aston Liu

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Recent development in low-moisture foods: Microbial safety and thermal process 由 Shuxiang Liu, M. S. Roopesh, Juming Tang, Qingping Wu, Wen Qin

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Continued Process Verification for COVID-19 Vaccine Formulation and Packaging (recombinant) 由 Paulo Silva, Pedro Miguel Alves Ribeiro Correia, Daiane Grugel, Victor Ferreira, Rayane Gonçalves

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Upstream cell culture process characterization and in-process control strategy development at pandemic speed 由 Jianlin Xu, Jianfa Ou, Kyle P. McHugh, Michael Borys, Anurag Khetan

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Application of Quality by design approach in the development of biosimilars monoclonal antibodies Nivolumab and Pembrolizumab 由 Anna Araújo, Iaralice Souza, Hugo Defendi

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ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSOR 由 Paula Thais Gozzi, Fernanda Giacomini Bueno, Patrícia Moura da Rosa Zimmermann, Liberato Brum

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Development of Biopredictive Dissolution Method for Extended-Release Desvenlafaxine Tablets 由 Gustavo Vaiano Carapeto, Marcelo Dutra Duque, Michéle Georges Issa, Humberto Gomes Ferraz

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Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development 由 Jia Guo, Regina Kufer, Delia Li, Stefanie Wohlrab, Midori Greenwood‐Goodwin, Feng Yang

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Caco-2 Cell Line Standardization with Pharmaceutical Requirements and In Vitro Model Suitability for Permeability Assays 由 Marta Kuś-Słowińska, Izabela Ibragimow, Hanna Piotrowska–Kempisty

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Determination and Validation of Tiaprofenic Acid in Human Plasma: A Detailed LC-MS/MS-Based Analysis Following ICH M10 Guidelines and the Accuracy Profile Approach 由 Houda Bouchafra, Aimen El Orche, Choukri El Khabbaz, Amine Cheikh, My El Abbés Faouzi, Yahia Cherrah, Lhoussaine Zarayby, Aziz Hirri

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