Michael Hongwei Xie
Overview
Explore the profile of Michael Hongwei Xie including associated specialties, affiliations and a list of published articles.
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Articles
7
Citations
119
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Recent Articles
1.
Zhang L, Fei M, Tian Y, Li S, Zhu X, Wang L, et al.
J Pharm Biomed Anal
. 2020 Sep;
190:113527.
PMID: 32911382
Capillary electrophoresis sodium dodecyl sulfate (CE-SDS), either in reduced (rCE-SDS) or non-reduced (nrCE-SDS) form, is widely used for purity evaluation and impurity analysis of monoclonal antibody (mAb) drugs. The accuracy...
2.
Zhang E, Xie L, Qin P, Lu L, Xu Y, Gao W, et al.
AAPS J
. 2020 May;
22(3):69.
PMID: 32385732
Quality by design (QbD) is an efficient but challenging approach for the development of biosimilar due to the complex relationship among process, quality, and efficacy. Here, the analytical similarity of...
3.
Xie L, Zhang E, Xu Y, Gao W, Wang L, Xie M, et al.
BioDrugs
. 2020 Feb;
34(3):363-379.
PMID: 32072477
Background: A biosimilar needs to demonstrate its similarity to the originator reference product (RP) in terms of structural and functional properties as well as nonclinical and clinical outcomes. Objectives: The...
4.
Xu Y, Xie L, Zhang E, Gao W, Wang L, Cao Y, et al.
MAbs
. 2019 Feb;
11(3):606-620.
PMID: 30794092
Development of bio-therapeutics has exhibited exponential growth in China over the past decade. However, no biosimilar drug has been approved in China (CN) due to the lack of a national...
5.
Klapoetke S, Xie M
J Pharm Biomed Anal
. 2016 Nov;
132:238-246.
PMID: 27771573
Protein-level partial reduction was investigated as a novel sample preparation technique to characterize proteins with cystine knots or complex disulfide linkages. Human Factor Xa containing twelve disulfide bonds was selected...
6.
Spreter Von Kreudenstein T, Escobar-Carbrera E, Lario P, DAngelo I, Brault K, Kelly J, et al.
MAbs
. 2013 Aug;
5(5):646-54.
PMID: 23924797
While the concept of Quality-by-Design is addressed at the upstream and downstream process development stages, we questioned whether there are advantages to addressing the issues of biologics quality early in...
7.
Woods R, Xie M, Spreter Von Kreudenstein T, Ng G, Dixit S
MAbs
. 2013 Jul;
5(5):711-22.
PMID: 23884083
Bispecific IgG asymmetric (heterodimeric) antibodies offer enhanced therapeutic efficacy, but present unique challenges for drug development. These challenges are related to the proper assembly of heavy and light chains. Impurities...