Binodh Desilva

Binodh Desilva

UNVERIFIED PROFILE

Are you Binodh Desilva?   Register this Author

Register author
Binodh Desilva

Binodh Desilva

Publications by authors named "Binodh Desilva"

Are you Binodh Desilva?   Register this Author

63Publications

2492Reads

24Profile Views

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.

View Article

Download full-text PDF

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

The Journey to AAPS 2020: a Reflection from Strategic Planning to PharmSci 360.

AAPS PharmSciTech 2018 Nov 3;19(8):3325-3327. Epub 2018 Nov 3.

, 3601 Sweeten Creek Road, Chapel Hill, NC, 27514, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1208/s12249-018-1200-3DOI Listing
November 2018

Development and validation of a functional cell-based neutralizing antibody assay for ipilimumab.

Bioanalysis 2018 Aug 27;10(16):1273-1287. Epub 2018 Jun 27.

Analytical & Bioanalytical Operations, Bristol-Myers Squibb, Princeton, NJ 08543, USA.

View Article

Download full-text PDF

Source
https://www.future-science.com/doi/10.4155/bio-2018-0109
Publisher Site
http://dx.doi.org/10.4155/bio-2018-0109DOI Listing
August 2018

Surface plasmon resonance as a tool for ligand-binding assay reagent characterization in bioanalysis of biotherapeutics.

Bioanalysis 2018 Apr 27;10(8):559-576. Epub 2018 Apr 27.

Bioanalytical Sciences, Analytical & Bioanalytical Operations, Bristol-Myers Squibb, Princeton, NJ 08543, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.4155/bio-2017-0271DOI Listing
April 2018

A multiplexed immunocapture liquid chromatography tandem mass spectrometry assay for the simultaneous measurement of myostatin and GDF-11 in rat serum using an automated sample preparation platform.

Anal Chim Acta 2017 Aug 26;979:36-44. Epub 2017 Apr 26.

Analytical and Bioanalytical Operations, Research & Development, Bristol-Myers Squibb Co., Route 206 and Province Line Road, Princeton, NJ 08543, United States. Electronic address:

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.aca.2017.04.028DOI Listing
August 2017

Accelerating Regulated Bioanalysis for Biotherapeutics: Case Examples Using a Microfluidic Ligand Binding Assay Platform.

AAPS J 2017 01 27;19(1):82-91. Epub 2016 Oct 27.

Immunochemistry and Biomarkers, Analytical and Bioanalytical Operations, Bristol-Myers Squibb, Route 206 and Province Line Road, Princeton, New Jersey, 08543, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1208/s12248-016-0006-zDOI Listing
January 2017

Characterization of labeled reagents in ligand-binding assays by a surface plasmon resonance biosensor.

Bioanalysis 2017 Jan;9(2):193-207

BioAnalytical Sciences, Analytical & Bioanalytical Operations, Bristol-Myers Squibb, Princeton, NJ 08543, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.4155/bio-2016-0204DOI Listing
January 2017

Current Challenges and Potential Opportunities for the Pharmaceutical Sciences to Make Global Impact: An FIP Perspective.

J Pharm Sci 2016 09 23;105(9):2489-2497. Epub 2016 Jan 23.

School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia 5000, Australia.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.xphs.2015.12.001DOI Listing
September 2016

Immunoaffinity-coupled MS: best of both technologies.

Authors:
Binodh DeSilva

Bioanalysis 2016 Aug 11;8(15):1543-1544. Epub 2016 Jul 11.

Head, Analytical & Bioanalytical Operations, Bristol-Myers Squibb, Princeton, NJ 08540, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.4155/bio-2016-0143DOI Listing
August 2016

Development and characterization of antibody reagents to assess anti-PEG IgG antibodies in clinical samples.

Bioanalysis 2015 ;7(15):1869-83

Bristol-Myers Squibb Company, Rt 206 & Province Line Road, Princeton, NJ 08543, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.4155/bio.15.112DOI Listing
May 2016

Stability assessment in ligand-binding assays: a critical parameter for data integrity.

Bioanalysis 2015 ;7(11):1315-7

Department of Immunochemistry & Biomarker Development, Bristol-Myers Squibb, Route 206 & Province Line Road, Princeton, NJ 08543, USA.

View Article

Download full-text PDF

Source
http://www.future-science.com/doi/10.4155/bio.15.71
Publisher Site
http://dx.doi.org/10.4155/bio.15.71DOI Listing
March 2016

Development and Fit-for-Purpose Validation of a Soluble Human Programmed Death-1 Protein Assay.

AAPS J 2015 Jul 1;17(4):976-87. Epub 2015 May 1.

Bioanalytical Science-Biologics, Bristol-Myers Squibb, L4.016B, Route 206 & Province Line Rd, Princeton, New Jersey, 08543, USA,

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1208/s12248-015-9762-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4476994PMC
July 2015

Development and characterization of a free therapeutic ligand binding assay with assistance from kinetics modeling.

J Immunol Methods 2015 Apr 27;419:18-24. Epub 2015 Feb 27.

Bristol-Myers Squibb, Rt. 206 & Province Line Road, Princeton, NJ 08543, United States. Electronic address:

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jim.2015.02.009DOI Listing
April 2015

Development and validation of a liquid chromatography tandem mass spectrometry assay for the quantitation of a protein therapeutic in cynomolgus monkey serum.

J Chromatogr B Analyt Technol Biomed Life Sci 2015 Apr 16;988:81-7. Epub 2015 Feb 16.

Bioanalytical Sciences, Research & Development, Bristol-Myers Squibb Co., Route 206 and Province Line Road, Princeton, NJ 08543, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jchromb.2015.02.007DOI Listing
April 2015

Detection of drug specific circulating immune complexes from in vivo cynomolgus monkey serum samples.

J Immunol Methods 2015 Jan 20;416:124-36. Epub 2014 Nov 20.

Bristol-Myers Squibb Company, Princeton, NJ 08543-4000, United States.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jim.2014.11.007DOI Listing
January 2015

Bioanalytical method validation: concepts, expectations and challenges in small molecule and macromolecule--a report of PITTCON 2013 symposium.

AAPS J 2014 May 4;16(3):586-91. Epub 2014 Apr 4.

Office of Clinical Pharmacology, Center for Drug Evaluations and Research, United States Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1208/s12248-014-9597-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4012041PMC
May 2014

Matrix interference in ligand-binding assays: challenge or solution?

Bioanalysis 2014 Apr;6(8):1029-31

Bristol Myers Squibb, Route 206 & Provinceline Road, Princeton, NJ 08543, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.4155/bio.14.92DOI Listing
April 2014

Addressing matrix effects in ligand-binding assays through the use of new reagents and technology.

Bioanalysis 2014 Apr;6(8):1059-67

Bristol-Myers Squibb, Route 206 & Province Line Rd, Princeton, NJ 08543, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.4155/bio.14.75DOI Listing
April 2014

Innovative use of LC-MS/MS for simultaneous quantitation of neutralizing antibody, residual drug, and human immunoglobulin G in immunogenicity assay development.

Anal Chem 2014 Mar 17;86(5):2673-80. Epub 2014 Feb 17.

Analytical and Bioanalytical Development and ‡ Discovery Chemistry Synthesis, Bristol-Myers Squibb , Princeton, New Jersey 08540, United States.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1021/ac5001465DOI Listing
March 2014

Fully validated LC-MS/MS assay for the simultaneous quantitation of coadministered therapeutic antibodies in cynomolgus monkey serum.

Anal Chem 2013 Oct 26;85(20):9859-67. Epub 2013 Sep 26.

Analytical and Bioanalytical Development and ‡Discovery Chemistry Synthesis, Bristol-Myers Squibb , Princeton, New Jersey, United States.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1021/ac402420vDOI Listing
October 2013

Laboratory automation of high-quality and efficient ligand-binding assays for biotherapeutic drug development.

Bioanalysis 2013 Jul;5(13):1635-48

Pharmacokinetics & Drug Metabolism Department, Amgen Inc., MS: 30E-3-C, One Amgen Center Drive, Thousand Oaks, CA 91320, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.4155/bio.13.141DOI Listing
July 2013

A generic template for automated bioanalytical ligand-binding assays using modular robotic scripts in support of discovery biotherapeutic programs.

Bioanalysis 2013 Jul;5(14):1735-50

Bioanalytical Sciences - Biologics, Analytical & Bioanalytical Development, Bristol-Myers Squibb, Princeton, NJ 08543, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.4155/bio.13.154DOI Listing
July 2013

Rapid development of multiple 'fit-for-purpose' assays on an automatic microfluidic system using a streamlined process in support of early biotherapeutics discovery programs.

Bioanalysis 2013 Jul;5(14):1751-63

Bioanalytical Sciences-Biologics, Analytical & Bioanalytical Development, Bristol-Myers Squibb, Princeton, NJ 08540, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.4155/bio.13.152DOI Listing
July 2013

Bioanalysis of biomarkers for drug development.

Bioanalysis 2012 Oct;4(20):2425-6

Bioanalytical & Translational Sciences, Huntingdon Life Sciences, Cambridgeshire, PE28 4HS, UK.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.4155/bio.12.253DOI Listing
October 2012

Bioanalytical considerations in the comparability assessment of biotherapeutics.

Bioanalysis 2011 Mar;3(6):613-22

PKDM Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.4155/bio.11.25DOI Listing
March 2011

A strategy for improving comparability across sites for ligand binding assays measuring therapeutic proteins.

J Pharm Biomed Anal 2010 Nov 24;53(3):729-34. Epub 2010 Apr 24.

Pharmaceutical Services, Radix BioSolutions, Georgetown, TX, United States.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jpba.2010.04.022DOI Listing
November 2010

Strategies to minimize variability and bias associated with manual pipetting in ligand binding assays to assure data quality of protein therapeutic quantification.

J Pharm Biomed Anal 2010 Nov 28;53(3):623-30. Epub 2010 Apr 28.

Pharmacokinetics and Drug Metabolism, Amgen Inc, Thousand Oaks, CA, United States.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jpba.2010.04.025DOI Listing
November 2010

Bioanalytical method requirements and statistical considerations in incurred sample reanalysis for macromolecules.

Bioanalysis 2010 Sep;2(9):1587-96

Department of Pharmacokinetics & Drug Metabolism, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.4155/bio.10.75DOI Listing
September 2010

Novel approaches using alkaline or acid/guanidine treatment to eliminate therapeutic antibody interference in the measurement of total target ligand.

J Pharm Biomed Anal 2010 Apr 3;51(5):1128-33. Epub 2009 Dec 3.

Department of Pharmacokinetics & Drug Metabolism, Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320, United States.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jpba.2009.11.021DOI Listing
April 2010

Applications of a planar electrochemiluminescence platform to support regulated studies of macromolecules: benefits and limitations in assay range.

J Pharm Biomed Anal 2010 Feb 30;51(3):626-32. Epub 2009 Sep 30.

Pharmacokinetics and Drug Metabolism, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jpba.2009.09.035DOI Listing
February 2010

Tartrate-resistant acid phosphatase (TRACP 5b): a biomarker of bone resorption rate in support of drug development: modification, validation and application of the BoneTRAP kit assay.

J Pharm Biomed Anal 2009 Jul 20;49(5):1203-12. Epub 2009 Mar 20.

Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, CA 91320, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jpba.2009.03.002DOI Listing
July 2009

"Fit-for-purpose" method validation and application of a biomarker (C-terminal telopeptides of type 1 collagen) in denosumab clinical studies.

AAPS J 2009 Jun 22;11(2):385-94. Epub 2009 May 22.

Department of PKDM, Amgen Inc., One Amgen Center Driver, Mail Stop 30E-3-C, Thousand Oaks, California 91320, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1208/s12248-009-9115-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2691475PMC
June 2009

Experimental and statistical approaches in method cross-validation to support pharmacokinetic decisions.

J Pharm Biomed Anal 2009 Apr 13;49(3):613-8. Epub 2008 Dec 13.

Department of Pharmacokinetics and Drug Metabolism, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jpba.2008.12.008DOI Listing
April 2009

Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins.

J Pharm Biomed Anal 2009 Feb 6;49(2):311-8. Epub 2008 Dec 6.

Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, CA, USA.

View Article

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jpba.2008.11.039DOI Listing
February 2009

Key elements of bioanalytical method validation for macromolecules.

AAPS J 2007 May 18;9(2):E156-63. Epub 2007 May 18.

Centocor R&D Inc, Radnor, PA, USA.

View Article

Download full-text PDF

Source
http://link.springer.com/10.1208/aapsj0902017
Publisher Site
http://dx.doi.org/10.1208/aapsj0902017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2751404PMC
May 2007