Publications by authors named "Inna Vainshtein"

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Preclinical Characterization of XB010: A Novel Antibody-Drug Conjugate for the Treatment of Solid Tumors that Targets Tumor-Associated Antigen 5T4.
Brian A Mendelsohn, Kathleen R Gogas, Jeffrey N Higaki, Willy A Solis, Inna Vainshtein

Mol Cancer Ther· December 2025

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2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry ( - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV).
John Wojcik, Timothy Sikorski, Jian Wang, Yue Huang, Hiroshi Sugimoto, Inna Vainshtein

Bioanalysis· March 2025

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Preclinical Characterization of XB002, an Anti-Tissue Factor Antibody-Drug Conjugate for the Treatment of Solid Tumors.
Seema Kantak, Raffaella Faggioni, Allen G Cai, Maryam M Bhatti, Jing Li, Inna Vainshtein

Mol Cancer Ther· February 2025

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Correction to: Neutralizing Antibody Sample Testing and Report Harmonization.
Darshana Jani, Michele Gunsior, Robin Marsden, Kyra J Cowan, Susan C Irvin, Inna Vainshtein

AAPS J· September 2024

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Neutralizing Antibody Sample Testing and Report Harmonization.
Darshana Jani, Michele Gunsior, Robin Marsden, Kyra J Cowan, Susan C Irvin, Inna Vainshtein

AAPS J· July 2024

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Combining pharmacometric models with predictive and prognostic biomarkers for precision therapy in Crohn's disease: A case study of brazikumab.
Nan Zhang, Ming Liang Chan, Jing Li, Philip Z Brohawn, Bo Sun, Inna Vainshtein

CPT Pharmacometrics Syst Pharmacol· December 2023

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Neutralizing Antibody Validation Testing and Reporting Harmonization.
Heather Myler, João Pedras-Vasconcelos, Todd Lester, Francesca Civoli, Weifeng Xu, Inna Vainshtein

AAPS J· July 2023

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Anti-drug Antibody Sample Testing and Reporting Harmonization.
Darshana Jani, Robin Marsden, Michele Gunsior, Laura Schild Hay, Bethany Ward, Inna Vainshtein

AAPS J· October 2022

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Fatal capillary leak syndrome in a child with acute lymphoblastic leukemia treated with moxetumomab pasudotox for pre-transplant minimal residual disease reduction.
Nirali N Shah, Jennifer Schneiderman, Denison Kuruvilla, Deepa Bhojwani, Terry J Fry, Inna Vainshtein

Pediatr Blood Cancer· January 2021

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A Novel Pharmacodynamic Biomarker and Mechanistic Modeling Facilitate the Development of Tovetumab, a Monoclonal Antibody Directed Against Platelet-Derived Growth Factor Receptor Alpha, for Cancer Therapy.
Meina Liang, Bing Wang, Amy Schneider, Inna Vainshtein, Lorin Roskos

AAPS J· November 2020

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Molecular Mechanism of HER2 Rapid Internalization and Redirected Trafficking Induced by Anti-HER2 Biparatopic Antibody.
Jackie Cheng, Meina Liang, Miguel F Carvalho, Natalie Tigue, Raffaella Faggioni, Inna Vainshtein

Antibodies (Basel)· September 2020

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Results from an international phase 2 study of the anti-CD22 immunotoxin moxetumomab pasudotox in relapsed or refractory childhood B-lineage acute lymphoblastic leukemia.
Nirali N Shah, Deepa Bhojwani, Keith August, André Baruchel, Yves Bertrand, Inna Vainshtein

Pediatr Blood Cancer· May 2020

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A novel approach to assess domain specificity of anti-drug antibodies to moxetumomab pasudotox, an immunotoxin with two functional domains.
Inna Vainshtein, Bo Sun, Lorin K Roskos, Meina Liang

J Immunol Methods· February 2020

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Characterisation of anifrolumab, a fully human anti-interferon receptor antagonist antibody for the treatment of systemic lupus erythematosus.
Jeffrey M Riggs, Richard N Hanna, Bhargavi Rajan, Kamelia Zerrouki, Jodi L Karnell, Inna Vainshtein

Lupus Sci Med· April 2018

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Development and analytical performance of a new ARCHITECT automated dipeptidyl peptidase-4 immunoassay.
Philip M Hemken, Nicolette M Jeanblanc, Tracey Rae, Susan E Brophy, Maria J Datwyler, Inna Vainshtein

Pract Lab Med· December 2017

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Correction: A CD80-Biased CTLA4-Ig Fusion Protein with Superior In Vivo Efficacy by Simultaneous Engineering of Affinity, Selectivity, Stability, and FcRn Binding.
Julie Douthwaite, Jacques Moisan, Cyril Privezentzev, Blagoje Soskic, Shereen Sabbah, Inna Vainshtein

J Immunol· September 2017

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A CD80-Biased CTLA4-Ig Fusion Protein with Superior In Vivo Efficacy by Simultaneous Engineering of Affinity, Selectivity, Stability, and FcRn Binding.
Julie Douthwaite, Jacques Moisan, Cyril Privezentzev, Blagoje Soskic, Shereen Sabbah, Inna Vainshtein

J Immunol· January 2017

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An immunoinhibition approach to overcome the impact of pre-existing antibodies on cut point establishment for immunogenicity assessment of moxetumomab pasudotox.
Amy K Schneider, Inna Vainshtein, Lorin K Roskos, Carlos Chavez, Bo Sun

J Immunol Methods· August 2016

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Receptor occupancy assessment by flow cytometry as a pharmacodynamic biomarker in biopharmaceutical development.
Meina Liang, Martin Schwickart, Amy K Schneider, Inna Vainshtein, Christopher Del Nagro

Cytometry B Clin Cytom· March 2016

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Multiplexing of receptor occupancy measurements for pharmacodynamic biomarker assessment of biopharmaceuticals.
Inna Vainshtein, Amy K Schneider, Bo Sun, Martin Schwickart, Lorin K Roskos

Cytometry B Clin Cytom· March 2016

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Evaluation of assay interference and interpretation of CXCR4 receptor occupancy results in a preclinical study with MEDI3185, a fully human antibody to CXCR4.
Martin Schwickart, Carlos Chavez, Simon Henderson, Inna Vainshtein, Nathan Standifer

Cytometry B Clin Cytom· March 2016

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Interference in immunoassays to support therapeutic antibody development in preclinical and clinical studies.
Martin Schwickart, Inna Vainshtein, Rozanne Lee, Amy Schneider, Meina Liang

Bioanalysis· May 2015

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Quantitative measurement of the target-mediated internalization kinetics of biopharmaceuticals.
Inna Vainshtein, Lorin K Roskos, Jackie Cheng, Matthew A Sleeman, Bing Wang

Pharm Res· January 2015

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Pharmacokinetic and pharmacodynamic comparability study of moxetumomab pasudotox, an immunotoxin targeting CD22, in cynomolgus monkeys.
Bing Wang, Meina Liang, Zhenling Yao, Inna Vainshtein, Rozanne Lee

J Pharm Sci· January 2013

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Mechanistic modeling of antigen sink effect for mavrilimumab following intravenous administration in patients with rheumatoid arthritis.
Bing Wang, Yvonne Y Lau, Meina Liang, Inna Vainshtein, Mikhail Zusmanovich

J Clin Pharmacol· August 2012

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