Publications on Bioanalysis and Immunogenicity of Biotherapeutics
Renuka Pillutla, Manuela Braun, David Christopher, Douglas Donaldson, Carol Gleason, Boris Gorovits, Tobias Haslberger, Ling He, Mark Qian, Jorge Quiroz, Enaksha Wickremsinhe, Lakenya Williams. Recommendations for Singlet-Based Approach in Ligand Binding Assays. Bioanalysis J 2020
Tan CY, Steeno GS, You Z, Gaitonde P, Cai CH, Kamerud J, Gorovits B, Baltrukonis DJ. Criteria to Reevaluate Anti-drug Antibody Assay Cut Point Suitability in the Target Population. AAPS J. 2020 Jan 3;22(2):19
Gorovits, Boris, Michele Fiscella, Mike Havert, Eugen Koren, Brian Long, Mark Milton, Shobha Purushothama. Recommendations for the Development of Anti-Viral Vector Neutralizing Antibody Assays. AAPS J. 2020 Jan 6;22(2):24
Zhu L, Wang Y, Joyce A, Djura I, Gorovits B. Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling. Pharm Res. 2019 Oct 25;36(12):169. doi: 10.1007/s11095-019-2699-z.
Piccoli S et al 2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62). Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10.
Boris Gorovits, Kun Peng, Arno Kromminga. Current considerations on characterization of immune response to Multi domain biotherapeutics. BioDrugs. 2019 Oct 22. doi: 10.1007/s40259-019-00389-8
Ying Wang, Michael Luong, Crisanto Guadiz, Minlei Zhang, Boris Gorovits Addressing soluble target interference in the development of a functional assay for the detection of neutralizing antibodies against a BCMA-CD3 bispecific antibody J Immunol Methods. 2019 Aug 7:112642. doi: 10.1016/j.jim.2019.112642.
Boris Gorovits, Jean-Claude Marshall, Justin Smith, Laurence O Whiteley, Hendrik Neubert. Bioanalysis of Adeno-Associated Virus Gene Therapy Therapeutics: Regulatory Expectations. Bioanalysis, In Press October 2019
Boris Gorovits, Eugene Koren. Immunogenicity of Chimeric Antigen Receptor T-Cell Therapeutics BioDrugs. 2019 Jun;33(3):275-284. doi: 10.1007/s40259-019-00354-5.
Boris Gorovits, Ying Wang, Liang Zhu, Marcela Araya, John Kamerud, Christopher Lepsy. Anti-Drug Antibody Assay Conditions Significantly Impact Assay Screen and Confirmatory Cut-Points. AAPS J. 2019 Jun 3;21(4):71. doi: 10.1208/s12248-019-0342-x
Boris Gorovits, Marcela Araya Roldan, Daniel Baltrukonis, Chun-Hua Cai, Jean Donley, Darshana Jani, John Kamerud, Frederick McCush, Jeffrey S Thomas, Ying Wang. Anti-Drug Antibody Assay Validation: Improved Reporting of the Assay Selectivity via Simpler PC Recovery Data Analysis. AAPS J. 2019 Jun 18;21(5):76. doi: 10.1208/s12248-019-0347-5
Shobha Purushothama, Boris Gorovits. Unwanted Immunogenicity Responses to Biotherapeutics. In. Handbook of Biomarkers and Precision Medicine Ed. C. Carini, M. Fidock, A van Gool 2019, New York, Imprint Chapman and Hall/CRC, DOI https://doi.org/10.1201/9780429202872, eBook ISBN9780429202872
Boris Gorovits. Factor Xa: Case Study. In. Handbook of Biomarkers and Precision Medicine Ed. C. Carini, M. Fidock, A van Gool 2019, New York, Imprint Chapman and Hall/CRC, DOI https://doi.org/10.1201/9780429202872, eBook ISBN9780429202872
Susan Hurst, Tracey Clark, Deborah Finco, Amanda Leskovar, Debra O'Neil & Boris Gorovits. Bioanalytical assays in support of tanezumab developmental and reproductive toxicity studies: challenges and learnings. Bioanalysis. 2019 Jun;11(12):1207-1216. doi: 10.4155/bio-2018-0314. Epub 2019 Jun 17.
Xiang Y, Parng C, Olson K, Seletskaia E, Gorovits B, Jani D, Caiazzo T, Joyce A, Donley J. Neutralizing antibody assay development with high drug and target tolerance to support clinical development of an anti-TFPI therapeutic monoclonal antibody. AAPS J. 2019 Mar 29;21(3):46. doi: 10.1208/s12248-019-0320-3.
Yuhong Xiang, John Kamerud, Jean Donley, Katrina Olson, Teresa Caiazzo, Dave Yeung1, Chuenlei Parng, and Boris Gorovits 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):4. doi: 10.1208/s12248-018-0274-x.
Heather Myler, Boris Gorovits, Kelli Phillips, Viswanath Devanarayan, Adrienne Clements-Egan, George R. Gunn, Susan Kirshner, Binodh DeSilva, and Vinod P. Shah. Report on the AAPS Immunogenicity Guidance Forum. The AAPS Journal 2019, 21:55. DOI: 10.1208/s12248-019-0328-8
Sheldon Leung, Corinna Fiorotti, Michael Bibik, David Brown, Martin A. Gleeson, Boris Gorovits. Multiplexed immunoassay approach to characterize anti-drug antibody like specific reactivity. Bioanalysis. 2019 Apr;11(8):703-712. doi: 10.4155/bio-2018-0072
Stevenson L, Richards S, Pillutla R, Torri A, Kamerud J, Mehta D, Keller S, Purushothama S, Gorovits B, Litwin V et al 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. doi: 10.4155/bio-2018-0287
Chuenlei Parng, Michael Bolt, Debra D. Pittman, Teresa Caiazzo, Lisa Dyleski, Boris Gorovits, and Rob Webster Induction and Impact of Anti-Drug Responses Elicited by a Human Recombinant Coagulation Factor FXaI16L in Preclinical Species. The AAPS Journal (2019) 21:52. DOI: 10.1208/s12248-019-0324-z
Darshana Jani, John Nowak, Ying Chen, Joseph Boni Boris Gorovits Assessment of clinical immunogenicity of inotuzumab ozogamicin in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia AAPS Open (2018) 4:1 DOI 10.1186/s41120-018-0021-5
Xiang Y, Donley J, Seletskaia E, Shingare S, Kamerud J, Gorovits B. 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 Mar 13;20(3):45. doi: 10.1208/s12248-018-0208-7
Gorovits B, Baltrukonis DJ, Bhattacharya I, Birchler MA, Finco D, Sikkema D, Vincent MS, Lula S, Marshall L, Hickling TP Immunoassay methods used in clinical studies for the detection of anti-drug antibodies to adalimumab and infliximab. Clin Exp Immunol. 2018 Feb 12. doi: 10.1111/cei.13112
Mitra Azadeh, Boris Gorovits, John Kamerud et al Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves AAPS J. 2017 Dec 27;20(1):22. doi: 10.1208/s12248-017-0159-4
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 – LBA: immunogenicity, biomarkers and PK assays) Bioanalysis 2017 9(24) DOI: 10.4155/bio-2017-4974
Li Xue, Adrienne Clements-Egan, Lakshmi Amaravadi, Mary Birchler, Boris Gorovits et al Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development AAPS Journal 19(6) 2017
Parng C., Markiewicz V., Chen J., Leary B., Duriga N., Dyleski L., Caiazzo T., Bolt M., Joyce A., Gorovits B., Pittman D., Webster R. Preclinical Pharmacokinetics, Pharmacodynamics, Tissue Distribution and Interspecies scaling of Recombinant Human Coagulation Factor XaI16L. J Pharm Sci April 2017
Boris Gorovits and Renuka Pillutla. Emerging bioanalytical methods for the bioanalysis of biotherapeutics. In: Comprehensive Medicinal Chemistry 3rd Edition. Reference Module in Chemistry, Molecular Sciences and Chemical Engineering Editor Ved Srivastava and David Rotella. Elsevier. December 2016 32.82 DOI: 10.1016/B978-0-12-409547-2.12418-7
Mark Arnold, Eric Fluhler and Boris Gorovits Chapter: Understanding Bioanalysis Regulations. In Regulated Bioanalysis: Fundamentals and Practice. Editors: Mario L. Rocci Jr., and Steven Lowes, Springer. Chapter January 2017 pp.15-38 DOI: 10.1007/978-3-319-54802-9_2
Zhong D., Clements-Egan A., Gorovits B., Maia M., Sumner G., Theobald V., Wu Y., Rajadhyaksha M. Drug target interference in immunogenicity assays: Recommendations and mitigation strategies AAPS J. 2017 AAPS J. 2017 Nov;19(6):1564-1575. doi: 10.1208/s12248-017-0148-7. Epub 2017 Oct 23.
Richards S., Amaravadi L., Pillutla R., et al 2016 White Paper on Recent Issues in Bioanalysis: Focus on Biomarker Assay Validation (BAV). Bioanalysis. Bioanalysis. 2016 Dec;8(23):2475-2496.
Gorovits, B., Clements-Egan, A., Birchler, M., Liang, M., Myler, H., Peng, K., Purushothama, S., Rajadhyaksha, M., Salazar-Fontana, L., Sung, C. and Xue, L., 2016, Pre-existing Antibody: Biotherapeutic Modality-Based Review. AAPS J 18, 311-20.
Seema Chauhan, Jason A Delcarpini, Qiang Qu, Boris Gorovits Mitigation of Pre-existing Antibodies to a Biotherapeutic in Non-clinical Species When Establishing Anti-drug Antibody Assay Cutpoint AAPS Journal 19(1) November 2016 DOI: 10.1208/s12248-016-0011-2
Gorovits, B. and Shord, S. 2015 Novel methods in bioanalysis and characterization of antibody-drug conjugates. In: Novel Methods in Bioanalysis and Characterization of Antibody-Drug Conjugates, Future Science Book Series. Future Science Ltd, p. 2-4.
Kumar, S. and Gorovits, B. 2015 Application of ligand-binding assays for bioanalysis of antibody-drug conjugates. In: Novel Methods in Bioanalysis and Characterization of Antibody-Drug Conjugates, Future Science Book Series. Future Science Ltd, p. 20-35.
Seema Kumar, Lindsay E King, Tracey H Clark, Boris Gorovits Antibody-drug conjugates nonclinical support: From early to late nonclinical bioanalysis using ligand-binding assays Bioanalysis 2015, 7(13):1605-1617
Brian Booth, Mark E Arnold, Binodh DeSilva, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Gorovits, Sam H Haidar, John A. (John Abraham) Kadavil, Steve Lowes, Robert Nicholson, Marie Rock, Michael Skelly, Lauren F Stevenson, Sriram Subramaniam, Russell Weiner, Eric Woolf Workshop Report: Crystal City V-Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance. The AAPS Journal 2014
Boris Gorovits, Eric Wakshull, Renuka Pillutla, Yuanxin Xu, Marta Starcevic Manning, Jaya Goyal Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics, J. Immunol. Methods Volume 408:1-12, 2014
Hussain, A., Gorovits, B., Leal, M. and Fluhler, E., 2013, Pharmacokinetics of Immunoconjugate Anti-Cancer Agent CMD-193 in Rats: Ligand Binding Assay Based Approach to Determine In Vivo Immunoconjugate Stability. Bioanalysis. 6(1):21-32, 2014
Stanley Roberts, Paul Andrews, Diann Blanset, Kelly M Flagella, Boris Gorovits, Carmel M Lynch, Pauline L Martin, Kimberly Kramer-Stickland, Stephane Thibault, Garvin Warner Considerations for the Nonclinical Safety Evaluation of Antibody Drug Conjugates for Oncology. Regulatory Toxicology and Pharmacology Regulatory Toxicology & Pharmacology. 67(3):382-91, 2013 Dec
Stevenson, Lauren, Kelley, Marian, Gorovits, Boris, Kingsley, Clare, Myler, Heather, Österlund, Karolina, Muruganandam, Arumugam, Minamide, Yoshiyuki, Dominguez, Mario Large Molecule specific assay operation: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team. AAPS Journal. 16(1):83-8, 2014 Jan.
Gorovits, B., Alley, S.C., Bilic, S., Booth, B., Kaur, S., Oldfield, P., Purushothama, S., Rao, C., Shord, S. and Siguenza, P. Bioanalysis of antibody-drug conjugates: American Association of Pharmaceutical Scientists Antibody-Drug Conjugate Working Group position paper. Bioanalysis 5, 997-1006, 2013
Marian Kelley, Ago B. Ahene, Boris Gorovits, John Kamerud, Lindsay E. King, Thomas McIntosh, Jihong Yang Theoretical Considerations and Practical Approaches to Address the Effect of Anti-drug Antibody (ADA) on Quantification of Biotherapeutics in Circulation AAPS Journal July 2013, Volume 15, Issue 3, pp 646-658 May 2013
Gorovits, B. and Krinos-Fiorotti, C., Proposed mechanism of off-target toxicity for antibody-drug conjugates driven by mannose receptor uptake. Cancer Immunology, Immunotherapy 62, 217-23, 2013
Neubert, H., Fountain, S., King, L., Clark, T., Weng, Y., O'Hara, D.M., Li, W., Leung, S., Ray, C., Palandra, J., Ocana, M.F., Chen, J., Ji, C., Wang, M., Long, K., Gorovits, B. and Fluhler, E., 2012, Tissue bioanalysis of biotherapeutics and drug targets to support PK/PD. Bioanalysis 4, 2589-604.
Bonita Rup, Corinna Fiorotti, Boris Gorovits, Hendrik Neubert Biophysical Methods for Biotherapeutics: Discovery and Development Applications. Editor: Tapan K. Das, S.2 Chapter 14: Bioanalytical Methods and Immunogenicity Assays 2013
Li Xue, Rasheeda Johnson, Boris Gorovits Prevalence and Isotypic Complexity of the Anti-Chinese Hamster Ovary Host Cell Protein Antibodies in Normal Human Serum The AAPS Journal, 2009, AAPS J. 2010 March; 12(1): 98–106
Gopi Shankar, Viswanath Devanarayan, Yu Chen Barrett, Ron Bowsher, Deborah Finco-Kent, Michele Fiscella, Boris Gorovits, Susan Kirschner, Michael Moxness, Thomas Parish, Valerie Quarmby, Elizabeth Shores, Holly Smith, Wendell Smith, Jingling Zhong, Linda Zuckerman & Eugen Koren Recommendations For The Validation Of Immunoassays Used For Detection Of Host Antibodies Against Biotechnology Products, J Pharm Biomed Anal. 2008 Dec 15;48(5):1267-81. Epub 2008 Sep 19.
Eugen Koren, Holly W. Smith, Elizabeth Shores, Gopi Shankar, Deborah Finco-Kent, Bonita Rup, Yu-Chen Barett, Viswanath Devanarayan, Boris Gorovits, Shalini Gupta, Thomas Parish, Valerie Quarmby, Michael Moxness, Steven J. Swanson, Gary Taniguchi, Linda A. Zuckerman, Christopher, C. Stebbins, Anthony Mire-Sluis Recommendations on Risk-Based Strategies for Detection and Characterization of Antibodies against Biotechnology Products, J Immunol Methods. 2008 Apr 20;333(1-2):1-9
Buckwalter M, Dowell JA, Korth-Bradley J, Gorovits B, Mayer PR Pharmacokinetics of gemtuzumab ozogamicin as a single-agent treatment of pediatric patients with refractory or relapsed acute myeloid leukemia, J Clin Pharmacol. 2004 44(8):873-80.
Mark Panda, Boris M. Gorovits, Paul M. Horowitz. Productive and Nonproductive Intermediates in the Folding of Denatured Rhodanese. J Biol Chem. 2000 Jan 7; 275(1):63
Boris M. Gorovits, Paul M. Horowitz. High hydrostatic pressure can reverse aggregation of protein folding intermediates and facilitate acquisition of native structure. Biochemistry 1998 Apr 28;37(17) pp. 6132-5
Boris M. Gorovits, Jesse Ybarra, and Paul M. Horowitz. ATP Hydrolysis is Critical for Induction of Conformational Changes in GroEL that Expose Hydrophobic Surfaces, J of Biological Chemistry 272 (1997), pp. 6842-6845
Boris M. Gorovits, Jeffrey W. Seale and Paul M. Horowitz. Residual Structure in the Urea Denatured Chaperonin GroEL, Biochemistry, v.34 (1995), pp. 13928-13923
Boris M. Gorovits, CS Raman, and Paul M. Horowitz. High Hydrostatic Pressure Induces the Dissociation of Cpn60 Tetradecamers and Reveals a Plasticity of the Monomers, J. Biological Chemistry v.270 (1995), pp. 2061-2066