Citations (29)
Keep up to date with the latest research on this topic with citation updates for this article.
Read on this site (4)
Michel Degueldre, Annemie Wielant, Eglantine Girot, Will Burkitt, John O’Hara, Gaël Debauve, Annick Gervais & Carl Jone. (2019) Native peptide mapping – A simple method to routinely monitor higher order structure changes and relation to functional activity. mAbs 11:8, pages 1391-1401.
Read now
Read now
Weichen Xu, Rod Brian Jimenez, Rachel Mowery, Haibin Luo, Mingyan Cao, Nitin Agarwal, Irina Ramos, Xiangyang Wang & Jihong Wang. (2017) A Quadrupole Dalton-based multi-attribute method for product characterization, process development, and quality control of therapeutic proteins. mAbs 9:7, pages 1186-1196.
Read now
Read now
Brian Kelley. (2016) Quality by Design risk assessments supporting approved antibody products. mAbs 8:8, pages 1435-1436.
Read now
Read now
Richard S Rogers, Nancy S Nightlinger, Brittney Livingston, Phil Campbell, Robert Bailey & Alain Balland. (2015) Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics. mAbs 7:5, pages 881-890.
Read now
Read now
Articles from other publishers (25)
Milos Drobnjakovic, Roger Hart, Boonserm (Serm) Kulvatunyou, Nenad Ivezic & Vijay Srinivasan. (2023) Current challenges and recent advances on the path towards continuous biomanufacturing. Biotechnology Progress.
Crossref
Crossref
S. V. Tishkov, E. V. Blynskaya, K. V. Alekseev & V. K. Alekseev. (2023) Features of risk analysis, assessment and control methods in pharmaceutical development. Russian Journal of Biotherapy 22:1, pages 28-41.
Crossref
Crossref
Burcu Mesut, Atakan Başkor & N. Buket Aksu. 2023. A Handbook of Artificial Intelligence in Drug Delivery. A Handbook of Artificial Intelligence in Drug Delivery
35
54
.
Daniela M. Zagalo, João Sousa & Sérgio Simões. (2022) Quality by design (QbD) approach in marketing authorization procedures of Non-Biological Complex Drugs: A critical evaluation. European Journal of Pharmaceutics and Biopharmaceutics 178, pages 1-24.
Crossref
Crossref
Xiaoyan Guan, Tamer Eris, Le Zhang, Da Ren, Margaret S. Ricci, Tiffany Thiel & Chetan T. Goudar. (2022) A high-resolution multi-attribute method for product characterization, process characterization, and quality control of therapeutic proteins. Analytical Biochemistry 643, pages 114575.
Crossref
Crossref
Yuko Ogata, Pamela M. Quizon, Nancy S. Nightlinger, Pongkwan Sitasuwan, Casey Snodgrass, L. Andrew Lee, Jeffrey D. Meyer & Richard S. Rogers. (2021) Automated multi‐attribute method sample preparation using high‐throughput buffer exchange tips. Rapid Communications in Mass Spectrometry 36:3.
Crossref
Crossref
Angela Bonaccorso, Giulia Russo, Francesco Pappalardo, Claudia Carbone, Giovanni Puglisi, Rosario Pignatello & Teresa Musumeci. (2021) Quality by design tools reducing the gap from bench to bedside for nanomedicine. European Journal of Pharmaceutics and Biopharmaceutics 169, pages 144-155.
Crossref
Crossref
David Saleh, Gang Wang, Federico Rischawy, Simon Kluters, Joey Studts & Jürgen Hubbuch. (2021)
In silico
process characterization for biopharmaceutical development following the quality by design concept
. Biotechnology Progress 37:6.
Crossref
Crossref
Zhiqi Hao, Benjamin Moore, Chengfeng Ren, Monica Sadek, Frank Macchi, Lindsay Yang, Jack Harris, Laura Yee, Emily Liu, Vanessa Tran, Milady Ninonuevo, Yan Chen & Christopher Yu. (2021) Multi-attribute method performance profile for quality control of monoclonal antibody therapeutics. Journal of Pharmaceutical and Biomedical Analysis 205, pages 114330.
Crossref
Crossref
Chen Qian, Ben Niu, Rod Brian Jimenez, Jihong Wang & Methal Albarghouthi. (2021) Fully automated peptide mapping multi-attribute method by liquid chromatography–mass spectrometry with robotic liquid handling system. Journal of Pharmaceutical and Biomedical Analysis 198, pages 113988.
Crossref
Crossref
Judith P. ter Horst, Sada L. Turimella, Frans Metsers & Alex Zwiers. (2021) Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019. Therapeutic Innovation & Regulatory Science 55:3, pages 583-590.
Crossref
Crossref
Pedro Sousa Sampaio & Cecília R. C. Calado. (2021)
Comparison of partial least squares‐discriminant analysis and soft independent modeling of class analogy methods for classification of
Saccharomyces cerevisiae
cells based on mid‐infrared spectroscopy
. Journal of Chemometrics 35:5.
Crossref
Crossref
Jinjiang Li & Duohai Pan. 2021. Protein Instability at Interfaces During Drug Product Development. Protein Instability at Interfaces During Drug Product Development
313
329
.
Bastiaan L. Duivelshof, Wim Jiskoot, Alain Beck, Jean-Luc Veuthey, Davy Guillarme & Valentina D’Atri. (2019) Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implications. Analytica Chimica Acta 1089, pages 1-18.
Crossref
Crossref
Larissa Pereira Brumano, Francisco Vitor Santos da Silva, Tales Alexandre Costa-Silva, Alexsandra Conceição Apolinário, João Henrique Picado Madalena Santos, Eduardo Krebs Kleingesinds, Gisele Monteiro, Carlota de Oliveira Rangel-Yagui, Brahim Benyahia & Adalberto Pessoa Junior. (2019) Development of L-Asparaginase Biobetters: Current Research Status and Review of the Desirable Quality Profiles. Frontiers in Bioengineering and Biotechnology 6.
Crossref
Crossref
Richard S. Rogers, Michael Abernathy, Douglas D. Richardson, Jason C. Rouse, Justin B. Sperry, Patrick Swann, Jette Wypych, Christopher Yu, Li Zang & Rohini Deshpande. (2017) A View on the Importance of “Multi-Attribute Method” for Measuring Purity of Biopharmaceuticals and Improving Overall Control Strategy. The AAPS Journal 20:1.
Crossref
Crossref
Brian D. Kelley, Annika Kleinjans & Philip Lester. 2018. Biopharmaceutical Processing. Biopharmaceutical Processing
1137
1149
.
Brian Kelley, Robert Kiss & Michael Laird. 2018. New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins. New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins
443
462
.
Jelena Djuris & Zorica Djuric. (2017) Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment. International Journal of Pharmaceutics 533:2, pages 346-356.
Crossref
Crossref
Dong Xu, Kentaro Marchionni, Yunli Hu, Wei Zhang & Zoran Sosic. (2017) Quantitative analysis of a biopharmaceutical protein in cell culture samples using automated capillary electrophoresis (CE) western blot. Journal of Pharmaceutical and Biomedical Analysis 145, pages 10-15.
Crossref
Crossref
Adrian Joseph, Stephen Goldrick, Michael Mollet, Richard Turner, Jean Bender, David Gruber, Suzanne S. Farid & Nigel Titchener-Hooker. (2017) An automated laboratory-scale methodology for the generation of sheared mammalian cell culture samples. Biotechnology Journal 12:5, pages 1600730.
Crossref
Crossref
Greg Troiano, Jim Nolan, Donald Parsons, Christina Van Geen Hoven & Stephen Zale. (2016) A Quality by Design Approach to Developing and Manufacturing Polymeric Nanoparticle Drug Products. The AAPS Journal 18:6, pages 1354-1365.
Crossref
Crossref
J. Felix Kepert, Mary Cromwell, Niklas Engler, Christof Finkler, Gerald Gellermann, Lynn Gennaro, Reed Harris, Raquel Iverson, Brian Kelley, Lynne Krummen, Nathan McKnight, Paul Motchnik, Volker Schnaible & Ron Taticek. (2016) Establishing a control system using QbD principles. Biologicals 44:5, pages 319-331.
Crossref
Crossref
Brian Kelley, Mary Cromwell & Joe Jerkins. (2016) Integration of QbD risk assessment tools and overall risk management. Biologicals 44:5, pages 341-351.
Crossref
Crossref
Jennifer Spooner, Trevor Wilkinson & Benjamin P Kemp. (2015) Current advances in the development of high-throughput purification strategies for the generation of therapeutic antibodies. Pharmaceutical Bioprocessing 3:6, pages 411-424.
Crossref
Crossref