Boris Gorovits

Boris Gorovits

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Boris Gorovits

Boris Gorovits

Publications by authors named "Boris Gorovits"

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Immunogenicity of Chimeric Antigen Receptor T-Cell Therapeutics.

BioDrugs 2019 Jun;33(3):275-284

Precision for Medicine, 2686 Middlefield Road, Redwood City, CA, 94063, USA.

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http://dx.doi.org/10.1007/s40259-019-00354-5DOI Listing
June 2019

Induction and Impact of Anti-Drug Responses Elicited by a Human Recombinant Coagulation Factor FXa in Preclinical Species.

AAPS J 2019 Apr 11;21(3):52. Epub 2019 Apr 11.

Pfizer Biomedicine Design, Pharmacokinetics Pharmacodynamics Metabolism, 610 Main St., Cambridge, Massachusetts, 02139, USA.

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http://dx.doi.org/10.1208/s12248-019-0324-zDOI Listing
April 2019

Report on the AAPS Immunogenicity Guidance Forum.

AAPS J 2019 Apr 16;21(4):55. Epub 2019 Apr 16.

Pharmaceutical Consultant, North Potomac, Maryland, 20878, USA.

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http://link.springer.com/10.1208/s12248-019-0328-8
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http://dx.doi.org/10.1208/s12248-019-0328-8DOI Listing
April 2019

Approaches to Resolve False Reporting in Neutralizing Antibody Assays Caused by Reagent Leaching from Affinity Capture Elution Solid Phase.

AAPS J 2018 Nov 6;21(1). Epub 2018 Nov 6.

Pfizer Worldwide Research & Development, Biomedicine Design, 1 Burtt Rd., Andover, Massachusetts, 01810, USA.

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http://link.springer.com/10.1208/s12248-018-0274-x
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http://dx.doi.org/10.1208/s12248-018-0274-xDOI Listing
November 2018

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).

Bioanalysis 2018 Nov 29. Epub 2018 Nov 29.

Amador Bioscience, Pleasanton, CA, USA (formerly of OncoMed, Redwood City, CA, USA).

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http://dx.doi.org/10.4155/bio-2018-0287DOI Listing
November 2018

A Simple Approach to Determine a Curve Fitting Model with a Correct Weighting Function for Calibration Curves in Quantitative Ligand Binding Assays.

AAPS J 2018 03 13;20(3):45. Epub 2018 Mar 13.

Pfizer Worldwide Research & Development, Biomedicine Design, 1 Burtt Rd, Andover, Massachusetts, 01810, USA.

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http://dx.doi.org/10.1208/s12248-018-0208-7DOI Listing
March 2018

Drug Target Interference in Immunogenicity Assays: Recommendations and Mitigation Strategies.

AAPS J 2017 11 23;19(6):1564-1575. Epub 2017 Oct 23.

Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.

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http://dx.doi.org/10.1208/s12248-017-0148-7DOI Listing
November 2017

Mitigation of Pre-existing Antibodies to a Biotherapeutic in Non-clinical Species When Establishing Anti-drug Antibody Assay Cutpoint.

AAPS J 2017 01 21;19(1):313-319. Epub 2016 Nov 21.

BioMedicine Design, Pfizer Inc, One Burtt Road, G-2002D, Andover, Massachusetts, 01810, USA.

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http://link.springer.com/10.1208/s12248-016-0011-2
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http://dx.doi.org/10.1208/s12248-016-0011-2DOI Listing
January 2017

Bioanalysis of antibody-drug conjugates.

Authors:
Boris Gorovits

Bioanalysis 2015 ;7(13):1559-60

Pfizer Inc., MA, USA.

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http://dx.doi.org/10.4155/bio.15.106DOI Listing
April 2016

Antibody-drug conjugates nonclinical support: from early to late nonclinical bioanalysis using ligand-binding assays.

Bioanalysis 2015 ;7(13):1605-17

Department of Pharmacokinetics, Dynamics & Metabolism, Pfizer Global R&D, One Burtt Road, Andover, MA 01810, USA.

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http://dx.doi.org/10.4155/bio.15.107DOI Listing
April 2016

Protein-based matrix interferences in ligand-binding assays.

Bioanalysis 2014 Apr;6(8):1131-40

Pfizer, 235 E 42nd St, NY 10017, USA.

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http://dx.doi.org/10.4155/bio.14.56DOI Listing
April 2014

PK of immunoconjugate anticancer agent CMD-193 in rats: ligand-binding assay approach to determine in vivo immunoconjugate stability.

Bioanalysis 2014 Jan;6(1):21-32

Pharmacokinetic, Pharmacodynamics & Drug Metabolism, Merck Sharp & Dohme Corp., West Point, Pennsylvania, USA.

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http://dx.doi.org/10.4155/bio.13.278DOI Listing
January 2014

Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology.

Regul Toxicol Pharmacol 2013 Dec 5;67(3):382-91. Epub 2013 Sep 5.

SAR Safety Assessment, 14677 Via Bettona, Suite #100 - 432, San Diego, CA 92127, USA. Electronic address:

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http://dx.doi.org/10.1016/j.yrtph.2013.08.017DOI Listing
December 2013

Proposed mechanism of off-target toxicity for antibody-drug conjugates driven by mannose receptor uptake.

Cancer Immunol Immunother 2013 Feb 8;62(2):217-23. Epub 2012 Dec 8.

Pfizer, Andover, NY, USA.

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http://dx.doi.org/10.1007/s00262-012-1369-3DOI Listing
February 2013

Immunogenicity: prediction, detection and effective assay development.

Authors:
Boris Gorovits

Bioanalysis 2010 Sep;2(9):1539-45

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http://dx.doi.org/10.4155/bio.10.121DOI Listing
September 2010

Prevalence and isotypic complexity of the anti-Chinese hamster ovary host cell protein antibodies in normal human serum.

AAPS J 2010 Mar 15;12(1):98-106. Epub 2009 Dec 15.

Global Pharmacokinetics, Dynamics and Metabolism - New Biological Entities, Pfizer (formally Drug Safety and Metabolism, Wyeth Research), Andover, Massachusetts 01810, USA.

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http://dx.doi.org/10.1208/s12248-009-9165-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2811637PMC
March 2010

Antidrug antibody assay validation: industry survey results.

Authors:
Boris Gorovits

AAPS J 2009 Mar 3;11(1):133-8. Epub 2009 Mar 3.

Wyeth Research, 401 N Middletown Rd., Pearl River, New York 10965, USA.

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http://dx.doi.org/10.1208/s12248-009-9091-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2664891PMC
March 2009