Literature DB >> 32718778

Advancing Mass Spectrometry Technology in cGMP Environments.

Da Ren1.   

Abstract

Mass spectrometry is a powerful analytical tool that has been widely used in the biotech industry. Recent trends of implementing a liquid chromatography-mass spectrometry (LC-MS) based multi-attribute method (MAM) in cGMP environments enables end-to-end monitoring and control of critical quality attributes (CQAs) of therapeutic proteins to ensure drug product quality.
Copyright © 2020 Elsevier Ltd. All rights reserved.

Entities:  

Keywords:  critical quality attributes (CQAs); current good manufacturing practice (cGMP); liquid chromatography-mass spectrometry (LC-MS); multi-attribute method (MAM); quality by design (QbD); therapeutic proteins

Mesh：

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Year:  2020        PMID： 32718778     DOI： 10.1016/j.tibtech.2020.06.007

Source DB:  PubMed          Journal:  Trends Biotechnol        ISSN： 0167-7799            Impact factor:   19.536


  3 in total

1.  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

2.  Automated multi-attribute method sample preparation using high-throughput buffer exchange tips.

Authors:  Yuko Ogata; Pamela M Quizon; Nancy S Nightlinger; Pongkwan Sitasuwan; Casey Snodgrass; L Andrew Lee; Jeffrey D Meyer; Richard S Rogers
Journal:  Rapid Commun Mass Spectrom       Date:  2022-01-30       Impact factor: 2.586

3.  Attribute Analytics Performance Metrics from the MAM Consortium Interlaboratory Study.

Authors:  Trina Mouchahoir; John E Schiel; Rich Rogers; Alan Heckert; Benjamin J Place; Aaron Ammerman; Xiaoxiao Li; Tom Robinson; Brian Schmidt; Chris M Chumsae; Xinbi Li; Anton V Manuilov; Bo Yan; Gregory O Staples; Da Ren; Alexander J Veach; Dongdong Wang; Wael Yared; Zoran Sosic; Yan Wang; Li Zang; Anthony M Leone; Peiran Liu; Richard Ludwig; Li Tao; Wei Wu; Ahmet Cansizoglu; Andrew Hanneman; Greg W Adams; Irina Perdivara; Hunter Walker; Margo Wilson; Arnd Brandenburg; Nick DeGraan-Weber; Stefano Gotta; Joe Shambaugh; Melissa Alvarez; X Christopher Yu; Li Cao; Chun Shao; Andrew Mahan; Hirsh Nanda; Kristen Nields; Nancy Nightlinger; Ben Niu; Jihong Wang; Wei Xu; Gabriella Leo; Nunzio Sepe; Yan-Hui Liu; Bhumit A Patel; Douglas Richardson; Yi Wang; Daniela Tizabi; Oleg V Borisov; Yali Lu; Ernest L Maynard; Albrecht Gruhler; Kim F Haselmann; Thomas N Krogh; Carsten P Sönksen; Simon Letarte; Sean Shen; Kristin Boggio; Keith Johnson; Wenqin Ni; Himakshi Patel; David Ripley; Jason C Rouse; Ying Zhang; Carly Daniels; Andrew Dawdy; Olga Friese; Thomas W Powers; Justin B Sperry; Josh Woods; Eric Carlson; K Ilker Sen; St John Skilton; Michelle Busch; Anders Lund; Martha Stapels; Xu Guo; Sibylle Heidelberger; Harini Kaluarachchi; Sean McCarthy; John Kim; Jing Zhen; Ying Zhou; Sarah Rogstad; Xiaoshi Wang; Jing Fang; Weibin Chen; Ying Qing Yu; John G Hoogerheide; Rebecca Scott; Hua Yuan
Journal:  J Am Soc Mass Spectrom       Date:  2022-08-26       Impact factor: 3.262
  3 in total

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