Research map: Qualification and Implementation of a Robust Multi-Attribute Method Platform Across Multiple Laboratories for High-Resolution Process Characterization of Biopharmaceutical Products

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Papers in this map

  1. Understanding Pharmaceutical Quality by Design · Lawrence X. Yu · 2014 · 1460 citations · Cited by this paper
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  15. Evaluating the impact of cell culture process parameters on monoclonal antibody N-glycosylation · Marija Ivarsson · 2014 · 128 citations · Cited by this paper
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  17. Multi-Attribute Method for Quality Control of Therapeutic Proteins · Sarah Rogstad · 2019 · 123 citations · Cited by this paper
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  19. A novel approach to investigate the effect of methionine oxidation on pharmacokinetic properties of therapeutic antibodies · Jan Olaf Stracke · 2014 · 114 citations · Cited by this paper
  20. Inter-laboratory study of an optimised peptide mapping workflow using automated trypsin digestion for monitoring monoclonal antibody product quality attributes · Silvia Millán‐Martín · 2020 · 77 citations · Cited by this paper
  21. Identification of Codon-Specific Serine to Asparagine Mistranslation in Recombinant Monoclonal Antibodies by High-Resolution Mass Spectrometry · Xin Yu · 2009 · 76 citations · Cited by this paper
  22. Comparative Evaluation of Disodium Edetate and Diethylenetriaminepentaacetic Acid as Iron Chelators to Prevent Metal -Catalyzed Destabilization of a Therapeutic Monoclonal Antibody · Shuxia Zhou · 2010 · 69 citations · Cited by this paper
  23. Automated mass spectrometry multi-attribute method analyses for process development and characterization of mAbs · Yvonne Song · 2021 · 65 citations · Cited by this paper
  24. Reversed-phase liquid-chromatographic mass spectrometric N-glycan analysis of biopharmaceuticals · Fabian Higel · 2013 · 62 citations · Cited by this paper
  25. Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control · Feng Yang · 2023 · 56 citations · Cited by this paper
  26. Fully automated peptide mapping multi-attribute method by liquid chromatography–mass spectrometry with robotic liquid handling system · Chen Qian · 2021 · 53 citations · Cited by this paper
  27. Advancing Mass Spectrometry Technology in cGMP Environments · Da Ren · 2020 · 41 citations · Cited by this paper
  28. Multi-attribute method performance profile for quality control of monoclonal antibody therapeutics · Zhiqi Hao · 2021 · 41 citations · Cited by this paper
  29. Unbiased in-depth characterization of CEX fractions from a stressed monoclonal antibody by mass spectrometry · François Griaud · 2017 · 36 citations · Cited by this paper
  30. A high-resolution multi-attribute method for product characterization, process characterization, and quality control of therapeutic proteins · Xiaoyan Guan · 2022 · 30 citations · Cited by this paper
  31. Metal Ion Leachates and the Physico-Chemical Stability of Biotherapeutic Drug Products · Sandeep Kumar · 2014 · 29 citations · Cited by this paper
  32. Multi attribute method implementation using a High Resolution Mass Spectrometry platform: From sample preparation to batch analysis · Sofia B. Carvalho · 2022 · 29 citations · Cited by this paper
  33. Identification of multiple serine to asparagine sequence variation sites in an intended copy product of LUCENTIS® by mass spectrometry · François Griaud · 2017 · 28 citations · Cited by this paper
  34. Technical considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory · Thomas Pohl · 2023 · 21 citations · Cited by this paper
  35. Exploring the Correlation between LC–MS Multi-Attribute Method and Conventional Chromatographic Product Quality Assays through Multivariate Data Analysis · Tingting Jiang · 2024 · 8 citations · Cited by this paper
  36. Discovery and Characterization of Unusual O‐Linked Glycosylation of IgG4 Antibody Using LC‐MS · Dariusz J. Janecki · 2024 · 8 citations · Cited by this paper
  37. Determination of ultra-trace metal-protein interactions in co-formulated monoclonal antibody drug product by SEC-ICP-MS · Laurence Whitty-Léveillé · 2023 · 7 citations · Cited by this paper
  38. Impact of four inorganic impurities – iron, copper, nickel and zinc - on the quality attributes of a Fc-fusion protein upon incubation at different temperatures · Pistacchio Alessandra · 2022 · 5 citations · Cited by this paper
  39. Addressing Acid-Catalyzed Deamidation and the Solubility of Hydrophobic Peptides in Multi-Attribute Method Workflows · Dan Bach Kristensen · 2023 · 5 citations · Cited by this paper

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