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1

Bioanalysis of antibody–drug conjugates: American Association of Pharmaceutical Scientists Antibody–Drug Conjugate Working Group position paper

Gorovits, Boris, Alley, Stephen C, Bilic, Sanela, Booth, Brian, Kaur, Surinder, Oldfield, Phillip, Purushothama, Shobha, Rao, Chetana, Shord, Stacy, Siguenza, Patricia

Journal:

Year:

2013

Language:

english

File:

PDF, 1.53 MB

english, 2013

2

Novel Methods in Bioanalysis and Characterization of Antibody-Drug Conjugates || Novel methods in bioanalysis and characterization of antibody–drug conjugates

Gorovits, Boris, Shord, Stacy

Year:

2015

Language:

english

File:

PDF, 254 KB

english, 2015

3

Anti-drug Antibody Assay Conditions Significantly Impact Assay Screen and Confirmatory Cut-Points

Gorovits, Boris, Wang, Ying, Zhu, Liang, Araya, Marcela, Kamerud, John, Lepsy, Christopher

Journal:

The AAPS Journal

Year:

2019

Language:

english

File:

PDF, 1.19 MB

english, 2019

4

Current Considerations for Immunoglobulin Isotype Characterization of Antibody Response against Biotherapeutics

Gorovits, Boris

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 408 KB

2020

5

Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development

Xue, Li, Clements-Egan, Adrienne, Amaravadi, Lakshmi, Birchler, Mary, Gorovits, Boris, Liang, Meina, Myler, Heather, Purushothama, Shobha, Manning, Marta Starcevic, Sung, Crystal

Journal:

The AAPS Journal

Year:

2017

Language:

english

File:

PDF, 432 KB

english, 2017

6

Anti-drug Antibody Assay Validation: Improved Reporting of the Assay Selectivity via Simpler Positive Control Recovery Data Analysis

Gorovits, Boris, Roldan, Marcela Araya, Baltrukonis, Daniel, Cai, Chun-Hua, Donley, Jean, Jani, Darshana, Kamerud, John, McCush, Frederick, Thomas, Jeffrey S., Wang, Ying

Journal:

The AAPS Journal

Year:

2019

Language:

english

File:

PDF, 1.07 MB

english, 2019

7

Theoretical Considerations and Practical Approaches to Address the Effect of Anti-drug Antibody (ADA) on Quantification of Biotherapeutics in Circulation

Marian Kelley, Ago B. Ahene, Boris Gorovits, John Kamerud…

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 416 KB

english, 2013

8

Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

Stevenson, Lauren, Kelley, Marian, Gorovits, Boris, Kingsley, Clare, Myler, Heather, Österlund, Karolina, Muruganandam, Arumugam, Minamide, Yoshiyuki, Dominguez, Mario

Journal:

The AAPS Journal

Year:

2014

Language:

english

File:

PDF, 154 KB

english, 2014

9

Novel Methods in Bioanalysis and Characterization of Antibody-Drug Conjugates || Analytical assays for antibody–drug conjugate selection and development

Gorovits, Boris, Shord, Stacy

Year:

2015

Language:

english

File:

PDF, 776 KB

english, 2015

10

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

Xiang, Yuhong, Kamerud, John, Donley, Jean, Olson, Katrina, Caiazzo, Teresa, Yeung, Dave, Parng, Chuenlei, Gorovits, Boris

Journal:

The AAPS Journal

Year:

2019

Language:

english

File:

PDF, 1.71 MB

english, 2019

11

Neutralizing Antibody Assay Development with High Drug and Target Tolerance to Support Clinical Development of an Anti-TFPI Therapeutic Monoclonal Antibody

Xiang, Yuhong, Parng, Chuenlei, Olson, Katrina, Seletskaia, Elena, Gorovits, Boris, Jani, Darshana, Caiazzo, Teresa, Joyce, Alison, Donley, Jean

Journal:

The AAPS Journal

Year:

2019

File:

PDF, 1.21 MB

2019

12

Neutralizing Antibody Assay Development with High Drug and Target Tolerance to Support Clinical Development of an Anti-TFPI Therapeutic Monoclonal Antibody

Xiang, Yuhong, Parng, Chuenlei, Olson, Katrina, Seletskaia, Elena, Gorovits, Boris, Jani, Darshana, Caiazzo, Teresa, Joyce, Alison, Donley, Jean

Journal:

The AAPS Journal

Year:

2019

Language:

english

File:

PDF, 1.21 MB

english, 2019

13

Immunogenicity of Chimeric Antigen Receptor T-Cell Therapeutics

Gorovits, Boris, Koren, Eugen

Journal:

Year:

2019

Language:

english

File:

PDF, 783 KB

english, 2019

14

Multiplexed immunoassay approach to characterize antidrug antibody like specific reactivity

Leung, Sheldon, Fiorotti, Corinna, Bibik, Michael, Brown, David, Gleeson, Martin A, Gorovits, Boris

Journal:

Year:

2019

Language:

english

File:

PDF, 824 KB

english, 2019

15

Bioanalytical assays in support of tanezumab developmental and reproductive toxicity studies: challenges and learnings

Hurst, Susan, Clark, Tracey, Finco, Deborah, Leskovar, Amanda, O’Neil, Debra, Gorovits, Boris

Journal:

Year:

2019

Language:

english

File:

PDF, 272 KB

english, 2019

16

Addressing soluble target interference in the development of a functional assay for the detection of neutralizing antibodies against a BCMA-CD3 bispecific antibody

Ying Wang, Y., Luong, Michael, Guadiz, Crisanto, Zhang, Minlei, Gorovits, Boris

Journal:

Journal of Immunological Methods

Year:

2019

Language:

english

File:

PDF, 1.30 MB

english, 2019

17

Criteria to Reevaluate Anti-drug Antibody Assay Cut Point Suitability in the Target Population

Tan, Charles Y., Steeno, Gregory S, You, Zhiping, Gaitonde, Puneet, Cai, Chun-Hua, Kamerud, John, Gorovits, Boris, Baltrukonis, Daniel J.

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 301 KB

2020

18

Correction to: Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays

Gorovits, Boris, Fiscella, Michele, Havert, Mike, Koren, Eugen, Long, Brian, Milton, Mark, Purushothama, Shobha

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 176 KB

english, 2020

19

Development of a Cell-Based Assay for the Detection of Neutralizing Antibodies to PF-06730512 Using Homogenous Time-Resolved Fluorescence

Luong, Michael, Wang, Ying, Berasi, Stephen P., Buhlmann, Janet E., Yang, Hongying, Gorovits, Boris

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 1.20 MB

english, 2020

20

Development of a Highly Specific Anti-drug Antibody Assay in Support of a Nanoparticle-based Therapeutic

Wang, Ying, Smith, Judith F., Araya, Marcela M., Liao, Kai-Hsin (Ken), Gorovits, Boris

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 1.08 MB

2020

21

Recommendations for singlet-based approach in ligand binding assays: an IQ Consortium perspective

Pillutla, Renuka, Gorovits, Boris, Gleason, Carol, Quiroz, Jorge, Christopher, David, Braun, Manuela, Brockus, Catherine, Donaldson, Douglas, Haslberger, Tobias, He, Ling, Qian, Mark, Sydor, Jens, Wic

Journal:

Year:

2020

File:

PDF, 1.75 MB

2020

22

Strategies to develop highly drug-tolerant cell-based neutralizing antibody assay: neutralizing antidrug antibodies extraction and drug depletion

Jiang, Zhihua, Kamerud, John, Zhang, Minlei, Ruiz, Carlos Cabrera, Guadiz, Crisanto, Fichtner, Alexander, Gorovits, Boris

Journal:

Year:

2020

File:

PDF, 1.12 MB

2020

23

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products

Gopi Shankar, Viswanath Devanarayan, Lakshmi Amaravadi, Yu Chen Barrett, Ronald Bowsher, Deborah Finco-Kent, Michele Fiscella, Boris Gorovits, Susan Kirschner, Michael Moxness, Thomas Parish, Valerie

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Year:

2008

Language:

english

File:

PDF, 581 KB

english, 2008

24

Antidrug Antibody Assay Validation: Industry Survey Results

Journal:

The AAPS Journal

Year:

2009

Language:

english

File:

PDF, 109 KB

english, 2009

25

Prevalence and Isotypic Complexity of the Anti-Chinese Hamster Ovary Host Cell Protein Antibodies in Normal Human Serum

Li Xue, Rasheeda Johnson, Boris Gorovits

Journal:

The AAPS Journal

Year:

2010

Language:

english

File:

PDF, 228 KB

english, 2010

26

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products

Eugen Koren, Holly W. Smith, Elizabeth Shores, Gopi Shankar, Deborah Finco-Kent, Bonita Rup, Yu-Chen Barrett, Viswanath Devanarayan, Boris Gorovits, Shalini Gupta, Thomas Parish, Valerie Quarmby, Mich

Journal:

Journal of Immunological Methods

Year:

2008

Language:

english

File:

PDF, 327 KB

english, 2008

27

Phosphorylation of the integrase protein of coliphage HK022

Mikhail Kolot, Rena Gorovits, Nava Silberstein, Boris Fichtman, Ezra Yagil

Journal:

Year:

2008

Language:

english

File:

PDF, 626 KB

english, 2008

28

Rhodanese folding is controlled by the partitioning of its folding intermediates

Boris M Gorovits, William A McGee, Paul M Horowitz

Journal:

Biochimica et Biophysica Acta (BBA) - Protein Structure and Molecular Enzymology

Year:

1998

Language:

english

File:

PDF, 196 KB

english, 1998

29

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

Gorovits, Boris, Krinos-Fiorotti, Corinna

Journal:

Cancer Immunology, Immunotherapy

Year:

2013

Language:

english

File:

PDF, 190 KB

english, 2013

30

Pre-Existing Biotherapeutic-Reactive Antibodies: Survey Results Within the American Association of Pharmaceutical Scientists

Xue, Li, Fiscella, Michele, Rajadhyaksha, Manoj, Goyal, Jaya, Holland, Claire, Gorovits, Boris, Morimoto, Alyssa

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 325 KB

english, 2013

31

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

Roberts, Stanley A., Andrews, Paul A., Blanset, Diann, Flagella, Kelly M., Gorovits, Boris, Lynch, Carmel M., Martin, Pauline L., Kramer-Stickland, Kimberly, Thibault, Stephane, Warner, Garvin

Journal:

Regulatory Toxicology and Pharmacology

Year:

2013

Language:

english

File:

PDF, 498 KB

english, 2013

32

Residual Structure in Urea-Denatured Chaperonin GroEL

Gorovits, Boris M., Seale, Jeffrey W., Horowitz, Paul M.

Journal:

Year:

1995

Language:

english

File:

PDF, 1.88 MB

english, 1995

33

High Hydrostatic Pressure Can Reverse Aggregation of Protein Folding Intermediates and Facilitate Acquisition of Native Structure

Gorovits, Boris M., Horowitz, Paul M.

Journal:

Year:

1998

Language:

english

File:

PDF, 91 KB

english, 1998

34

Reversible Oligomerization and Denaturation of the Chaperonin GroES †

Seale, Jeffrey W., Gorovits, Boris M., Ybarra, Jesse, Horowitz, Paul M.

Journal:

Year:

1996

Language:

english

File:

PDF, 247 KB

english, 1996

35

Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

Booth, Brian, Arnold, Mark E., DeSilva, Binodh, Amaravadi, Lakshmi, Dudal, Sherri, Fluhler, Eric, Gorovits, Boris, Haidar, Sam H., Kadavil, John, Lowes, Steve, Nicholson, Robert, Rock, Marie, Skelly,

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 261 KB

english, 2015

36

Conference Report: Immunogenicity: prediction, detection and effective assay development

Gorovits, Boris

Journal:

Year:

2010

Language:

english

File:

PDF, 423 KB

english, 2010

37

Protein-based matrix interferences in ligand-binding assays

Gorovits, Boris, McNally, Jim, Fiorotti, Corinna, Leung, Sheldon

Journal:

Year:

2014

Language:

english

File:

PDF, 719 KB

english, 2014

38

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

Hussain, Azher, Gorovits, Boris, Leal, Mauricio, Fluhler, Eric

Journal:

Year:

2014

Language:

english

File:

PDF, 826 KB

english, 2014

39

Bioanalysis of antibody–drug conjugates

Gorovits, Boris

Journal:

Year:

2015

Language:

english

File:

PDF, 798 KB

english, 2015

40

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)

Stevenson, Lauren, Amaravadi, Lakshmi, Myler, Heather, Salazar-Fontana, Laura, Gorovits, Boris, Kirshner, Susan, Xue, Li, Garofolo, Fabio, Alley, Stephen C, Thway, Theingi, Joyce, Alison, Bansal, Sure

Journal:

Year:

2014

Language:

english

File:

PDF, 1008 KB

english, 2014

41

Pre-existing Antibody: Biotherapeutic Modality-Based Review

Gorovits, Boris, Clements-Egan, Adrienne, Birchler, Mary, Liang, Meina, Myler, Heather, Peng, Kun, Purushothama, Shobha, Rajadhyaksha, Manoj, Salazar-Fontana, Laura, Sung, Crystal, Xue, Li

Journal:

The AAPS Journal

Year:

2016

Language:

english

File:

PDF, 398 KB

english, 2016

42

Pharmacokinetics of Gemtuzumab Ozogamicin as a Single-Agent Treatment of Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia

Buckwalter, Mary, Dowell, James A., Korth-Bradley, Joan, Gorovits, Boris, Mayer, Philip R.

Journal:

Journal of Clinical Pharmacology

Year:

2004

Language:

english

File:

PDF, 104 KB

english, 2004

43

A Visual Membrane Immunoassay for the Detection of Methamphetamine Using an Enzyme-Labeled Tracer Derived from Methamphetamine and Amphetamine.

CHOI, Myung Ja, GOROVITS, Boris M., CHOI, Jeongeun, SONG, EunYoung, NAM, Kyung Soo, PARK, Jongsei

Journal:

Biological & Pharmaceutical Bulletin

Year:

1994

File:

PDF, 1005 KB

1994

44

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

Kumar, Seema C, DelCarpini, Jason A, Qu, Qiang, Kane, Martin, Gorovits, Boris

Journal:

The AAPS Journal

Year:

2017

Language:

english

File:

PDF, 555 KB

english, 2017

45

Novel Methods in Bioanalysis and Characterization of Antibody-Drug Conjugates || Application of ligand-binding assays for bioanalysis of antibody–drug conjugates

Gorovits, Boris, Shord, Stacy

Year:

2015

Language:

english

File:

PDF, 962 KB

english, 2015

46

Preclinical Pharmacokinetics, Pharmacodynamics, Tissue Distribution and Interspecies scaling of Recombinant Human Coagulation Factor Xa I16L

Parng, Chuenlei, Markiewicz, Victoria, Chen, Jianqing, Leary, Beth, Duriga, Nicole, Dyleski, Lisa, Caiazzo, Teresa, Bolt, Michael, Joyce, Alison, Gorovits, Boris, Pittman, Debra D., Webster, Robert

Journal:

Journal of Pharmaceutical Sciences

Year:

2017

Language:

english

File:

PDF, 823 KB

english, 2017

47

Novel Methods in Bioanalysis and Characterization of Antibody-Drug Conjugates || Clinical pharmacology and assay consideration for characterizing pharmacokinetics and understanding efficacy and safety of antibody–drug conjugates

Gorovits, Boris, Shord, Stacy

Year:

2015

Language:

english

File:

PDF, 721 KB

english, 2015

48

[Methods in Enzymology] Molecular Chaperones Volume 290 || [25] Fluorescence anisotropy method for investigation of GroEL-GroES interaction

Gorovits, Boris M.

Year:

1998

Language:

english

File:

PDF, 234 KB

english, 1998

49

Drug Target Interference in Immunogenicity Assays: Recommendations and Mitigation Strategies

Zhong, Zhandong Don, Clements-Egan, Adrienne, Gorovits, Boris, Maia, Mauricio, Sumner, Giane, Theobald, Valerie, Wu, Yuling, Rajadhyaksha, Manoj

Journal:

The AAPS Journal

Year:

2017

Language:

english

File:

PDF, 1.66 MB

english, 2017

50

Bioanalysis of Biotherapeutics || MS and antibody-based approaches for the analysis of biotherapeutics

Gorovits, Boris

Year:

2013

Language:

english

File:

PDF, 1.38 MB

english, 2013

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