Literature DB >> 28207284

Characterization and QC of biopharmaceuticals by MS-based 'multi-attribute method': advantages and challenges.

Yun Zhang1, Jingzhong Guo1.   

Abstract

Keywords:  biopharmaceuticals; characterization; mass spectrometry; multi-attribute method; quality control; quality-by-design

Mesh:

Substances:

Year:  2017        PMID: 28207284     DOI: 10.4155/bio-2017-0004

Source DB:  PubMed          Journal:  Bioanalysis        ISSN: 1757-6180            Impact factor:   2.681


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  6 in total

Review 1.  Analytical comparability study of recombinant monoclonal antibody therapeutics.

Authors:  Alexandre Ambrogelly; Stephen Gozo; Amit Katiyar; Shara Dellatore; Yune Kune; Ram Bhat; Joanne Sun; Ning Li; Dongdong Wang; Christine Nowak; Alyssa Neill; Gomathinayagam Ponniah; Cory King; Bruce Mason; Alain Beck; Hongcheng Liu
Journal:  MAbs       Date:  2018-03-20       Impact factor: 5.857

2.  A View on the Importance of "Multi-Attribute Method" for Measuring Purity of Biopharmaceuticals and Improving Overall Control Strategy.

Authors:  Richard S Rogers; Michael Abernathy; Douglas D Richardson; Jason C Rouse; Justin B Sperry; Patrick Swann; Jette Wypych; Christopher Yu; Li Zang; Rohini Deshpande
Journal:  AAPS J       Date:  2017-11-30       Impact factor: 4.009

Review 3.  Interlaboratory Studies Using the NISTmAb to Advance Biopharmaceutical Structural Analytics.

Authors:  Katharina Yandrofski; Trina Mouchahoir; M Lorna De Leoz; David Duewer; Jeffrey W Hudgens; Kyle W Anderson; Luke Arbogast; Frank Delaglio; Robert G Brinson; John P Marino; Karen Phinney; Michael Tarlov; John E Schiel
Journal:  Front Mol Biosci       Date:  2022-05-05

4.  Establishment of a highly precise multi-attribute method for the characterization and quality control of therapeutic monoclonal antibodies.

Authors:  Michiko Tajiri-Tsukada; Noritaka Hashii; Akiko Ishii-Watabe
Journal:  Bioengineered       Date:  2020-12       Impact factor: 3.269

5.  An evaluation of instrument types for mass spectrometry-based multi-attribute analysis of biotherapeutics.

Authors:  Zhongqi Zhang; Pik K Chan; Jason Richardson; Bhavana Shah
Journal:  MAbs       Date:  2020 Jan-Dec       Impact factor: 5.857

6.  Multi attribute method implementation using a High Resolution Mass Spectrometry platform: From sample preparation to batch analysis.

Authors:  Sofia B Carvalho; Ricardo A Gomes; Anja Pfenninger; Martina Fischer; Michaela Strotbek; Inês A Isidro; Nihal Tugçu; Patrícia Gomes-Alves
Journal:  PLoS One       Date:  2022-01-27       Impact factor: 3.240

  6 in total

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