Publication

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)

Gupta, S., Richards, S., Amaravadi, L., Piccoli, S., Desilva, B., Pillutla, R., Stevenson, L., Mehta, D., Carrasco-Triguero, M., Neely, R., Partridge, M., Staack, R. F., Zhao, X., Gorovits, B., Kolaitis, G., Sumner, G., Stubenrauch, K-G., Zou, L., Amur, S., Beaver, C., Berger, I., Berisha, F., Birnboeck, H., Bower, J., Cho, S. J., Cludts, I., Cocea, L., Di Donato, L., Fischer, S., Fraser, S., Garofolo, F., Haidar, S., Haulenbeek, J., Hottenstein, C., Hu, J., Ishii-Watabe, A., Islam, R., Jani, D., Kadavil, J., Kamerud, J., Kramer, D., Kurki, P., MacMannis, S., McNally, J., Mullan, A., Papadimitriou, A., Pedras-Vasconcelos, J., Ray, S., Safavi, A., Saito, Y., Savoie, N., Fjording, M. S., Scheibner, K., Smeraglia, J., Song, A., Stouffer, B., Tampal, N., van der Strate, B., Verch, T., Welink, J., Xu, Y., Yang, T., Yengi, L., Zeng, J., Zhang, Y., Zhang, Y. & Zoog, S., Dec-2017, In : Bioanalysis. 9, 24, p. 1967-1996 30 p.

Research output: Contribution to journalArticleAcademicpeer-review

APA

Gupta, S., Richards, S., Amaravadi, L., Piccoli, S., Desilva, B., Pillutla, R., ... Zoog, S. (2017). 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, 9(24), 1967-1996. https://doi.org/10.4155/bio-2017-4974

Author

Gupta, Shalini ; Richards, Susan ; Amaravadi, Lakshmi ; Piccoli, Steven ; Desilva, Binodh ; Pillutla, Renuka ; Stevenson, Lauren ; Mehta, Devangi ; Carrasco-Triguero, Montserrat ; Neely, Robert ; Partridge, Michael ; Staack, Roland F. ; Zhao, Xuemei ; Gorovits, Boris ; Kolaitis, Gerry ; Sumner, Giane ; Stubenrauch, Kay-Gunnar ; Zou, Linglong ; Amur, Shashi ; Beaver, Chris ; Berger, Isabella ; Berisha, Flora ; Birnboeck, Herbert ; Bower, Joe ; Cho, Seongeun (Julia) ; Cludts, Isabelle ; Cocea, Laurent ; Di Donato, Lorella ; Fischer, Saloumeh ; Fraser, Stephanie ; Garofolo, Fabio ; Haidar, Sam ; Haulenbeek, Jonathan ; Hottenstein, Charles ; Hu, Jenny ; Ishii-Watabe, Akiko ; Islam, Rafiq ; Jani, Darshana ; Kadavil, John ; Kamerud, John ; Kramer, Daniel ; Kurki, Pekka ; MacMannis, Stephen ; McNally, Jim ; Mullan, Ashley ; Papadimitriou, Apollon ; Pedras-Vasconcelos, Joao ; Ray, Soma ; Safavi, Afshin ; Saito, Yoshiro ; Savoie, Natasha ; Fjording, Marianne Scheel ; Scheibner, Kara ; Smeraglia, John ; Song, An ; Stouffer, Bruce ; Tampal, Nilufer ; van der Strate, Barry ; Verch, Thorsten ; Welink, Jan ; Xu, Yuanxin ; Yang, Tong-yuan ; Yengi, Lilian ; Zeng, Jianing ; Zhang, Yan ; Zhang, Yanhua ; Zoog, Stephen. / 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). In: Bioanalysis. 2017 ; Vol. 9, No. 24. pp. 1967-1996.

Harvard

Gupta, S, Richards, S, Amaravadi, L, Piccoli, S, Desilva, B, Pillutla, R, Stevenson, L, Mehta, D, Carrasco-Triguero, M, Neely, R, Partridge, M, Staack, RF, Zhao, X, Gorovits, B, Kolaitis, G, Sumner, G, Stubenrauch, K-G, Zou, L, Amur, S, Beaver, C, Berger, I, Berisha, F, Birnboeck, H, Bower, J, Cho, SJ, Cludts, I, Cocea, L, Di Donato, L, Fischer, S, Fraser, S, Garofolo, F, Haidar, S, Haulenbeek, J, Hottenstein, C, Hu, J, Ishii-Watabe, A, Islam, R, Jani, D, Kadavil, J, Kamerud, J, Kramer, D, Kurki, P, MacMannis, S, McNally, J, Mullan, A, Papadimitriou, A, Pedras-Vasconcelos, J, Ray, S, Safavi, A, Saito, Y, Savoie, N, Fjording, MS, Scheibner, K, Smeraglia, J, Song, A, Stouffer, B, Tampal, N, van der Strate, B, Verch, T, Welink, J, Xu, Y, Yang, T, Yengi, L, Zeng, J, Zhang, Y, Zhang, Y & Zoog, S 2017, '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, vol. 9, no. 24, pp. 1967-1996. https://doi.org/10.4155/bio-2017-4974

Standard

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). / Gupta, Shalini; Richards, Susan; Amaravadi, Lakshmi; Piccoli, Steven; Desilva, Binodh; Pillutla, Renuka; Stevenson, Lauren; Mehta, Devangi; Carrasco-Triguero, Montserrat; Neely, Robert; Partridge, Michael; Staack, Roland F.; Zhao, Xuemei; Gorovits, Boris; Kolaitis, Gerry; Sumner, Giane; Stubenrauch, Kay-Gunnar; Zou, Linglong; Amur, Shashi; Beaver, Chris; Berger, Isabella; Berisha, Flora; Birnboeck, Herbert; Bower, Joe; Cho, Seongeun (Julia); Cludts, Isabelle; Cocea, Laurent; Di Donato, Lorella; Fischer, Saloumeh; Fraser, Stephanie; Garofolo, Fabio; Haidar, Sam; Haulenbeek, Jonathan; Hottenstein, Charles; Hu, Jenny; Ishii-Watabe, Akiko; Islam, Rafiq; Jani, Darshana; Kadavil, John; Kamerud, John; Kramer, Daniel; Kurki, Pekka; MacMannis, Stephen; McNally, Jim; Mullan, Ashley; Papadimitriou, Apollon; Pedras-Vasconcelos, Joao; Ray, Soma; Safavi, Afshin; Saito, Yoshiro; Savoie, Natasha; Fjording, Marianne Scheel; Scheibner, Kara; Smeraglia, John; Song, An; Stouffer, Bruce; Tampal, Nilufer; van der Strate, Barry; Verch, Thorsten; Welink, Jan; Xu, Yuanxin; Yang, Tong-yuan; Yengi, Lilian; Zeng, Jianing; Zhang, Yan; Zhang, Yanhua; Zoog, Stephen.

In: Bioanalysis, Vol. 9, No. 24, 12.2017, p. 1967-1996.

Research output: Contribution to journalArticleAcademicpeer-review

Vancouver

Gupta S, Richards S, Amaravadi L, Piccoli S, Desilva B, Pillutla R et al. 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 Dec;9(24):1967-1996. https://doi.org/10.4155/bio-2017-4974


BibTeX

@article{1a6e6a14cb0c4165931b2be09361c2ca,
title = "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)",
abstract = "The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small-and large-molecule analysis involving LC-MS, hybrid ligand-binding assay (LBA)/LC-MS and LBA approaches. This 2017 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for large-molecule bioanalysis, biomarkers and immunogenicity using LBA. Part 1 (LC-MS for small molecules, peptides and small molecule biomarkers) and Part 2 (hybrid LBA/LC-MS for biotherapeutics and regulatory agencies' inputs) are published in volume 9 of Bioanalysis, issues 22 and 23 (2017), respectively.",
keywords = "VALIDATION GROUP WORKSHOP, REGULATORY AGENCIES, 1-SMALL MOLECULES, 2-HYBRID LBA/LCMS, FULL IMMERSION, DRUG QUANTIFICATION, FOCUS, RECOMMENDATIONS, ANTIBODIES, LCMS",
author = "Shalini Gupta and Susan Richards and Lakshmi Amaravadi and Steven Piccoli and Binodh Desilva and Renuka Pillutla and Lauren Stevenson and Devangi Mehta and Montserrat Carrasco-Triguero and Robert Neely and Michael Partridge and Staack, {Roland F.} and Xuemei Zhao and Boris Gorovits and Gerry Kolaitis and Giane Sumner and Kay-Gunnar Stubenrauch and Linglong Zou and Shashi Amur and Chris Beaver and Isabella Berger and Flora Berisha and Herbert Birnboeck and Joe Bower and Cho, {Seongeun (Julia)} and Isabelle Cludts and Laurent Cocea and {Di Donato}, Lorella and Saloumeh Fischer and Stephanie Fraser and Fabio Garofolo and Sam Haidar and Jonathan Haulenbeek and Charles Hottenstein and Jenny Hu and Akiko Ishii-Watabe and Rafiq Islam and Darshana Jani and John Kadavil and John Kamerud and Daniel Kramer and Pekka Kurki and Stephen MacMannis and Jim McNally and Ashley Mullan and Apollon Papadimitriou and Joao Pedras-Vasconcelos and Soma Ray and Afshin Safavi and Yoshiro Saito and Natasha Savoie and Fjording, {Marianne Scheel} and Kara Scheibner and John Smeraglia and An Song and Bruce Stouffer and Nilufer Tampal and {van der Strate}, Barry and Thorsten Verch and Jan Welink and Yuanxin Xu and Tong-yuan Yang and Lilian Yengi and Jianing Zeng and Yan Zhang and Yanhua Zhang and Stephen Zoog",
year = "2017",
month = "12",
doi = "10.4155/bio-2017-4974",
language = "English",
volume = "9",
pages = "1967--1996",
journal = "Bioanalysis",
issn = "1757-6180",
publisher = "FUTURE SCI LTD",
number = "24",

}

RIS

TY - JOUR

T1 - 2017 White Paper on recent issues in bioanalysis

T2 - a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3-LBA: immunogenicity, biomarkers and PK assays)

AU - Gupta, Shalini

AU - Richards, Susan

AU - Amaravadi, Lakshmi

AU - Piccoli, Steven

AU - Desilva, Binodh

AU - Pillutla, Renuka

AU - Stevenson, Lauren

AU - Mehta, Devangi

AU - Carrasco-Triguero, Montserrat

AU - Neely, Robert

AU - Partridge, Michael

AU - Staack, Roland F.

AU - Zhao, Xuemei

AU - Gorovits, Boris

AU - Kolaitis, Gerry

AU - Sumner, Giane

AU - Stubenrauch, Kay-Gunnar

AU - Zou, Linglong

AU - Amur, Shashi

AU - Beaver, Chris

AU - Berger, Isabella

AU - Berisha, Flora

AU - Birnboeck, Herbert

AU - Bower, Joe

AU - Cho, Seongeun (Julia)

AU - Cludts, Isabelle

AU - Cocea, Laurent

AU - Di Donato, Lorella

AU - Fischer, Saloumeh

AU - Fraser, Stephanie

AU - Garofolo, Fabio

AU - Haidar, Sam

AU - Haulenbeek, Jonathan

AU - Hottenstein, Charles

AU - Hu, Jenny

AU - Ishii-Watabe, Akiko

AU - Islam, Rafiq

AU - Jani, Darshana

AU - Kadavil, John

AU - Kamerud, John

AU - Kramer, Daniel

AU - Kurki, Pekka

AU - MacMannis, Stephen

AU - McNally, Jim

AU - Mullan, Ashley

AU - Papadimitriou, Apollon

AU - Pedras-Vasconcelos, Joao

AU - Ray, Soma

AU - Safavi, Afshin

AU - Saito, Yoshiro

AU - Savoie, Natasha

AU - Fjording, Marianne Scheel

AU - Scheibner, Kara

AU - Smeraglia, John

AU - Song, An

AU - Stouffer, Bruce

AU - Tampal, Nilufer

AU - van der Strate, Barry

AU - Verch, Thorsten

AU - Welink, Jan

AU - Xu, Yuanxin

AU - Yang, Tong-yuan

AU - Yengi, Lilian

AU - Zeng, Jianing

AU - Zhang, Yan

AU - Zhang, Yanhua

AU - Zoog, Stephen

PY - 2017/12

Y1 - 2017/12

N2 - The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small-and large-molecule analysis involving LC-MS, hybrid ligand-binding assay (LBA)/LC-MS and LBA approaches. This 2017 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for large-molecule bioanalysis, biomarkers and immunogenicity using LBA. Part 1 (LC-MS for small molecules, peptides and small molecule biomarkers) and Part 2 (hybrid LBA/LC-MS for biotherapeutics and regulatory agencies' inputs) are published in volume 9 of Bioanalysis, issues 22 and 23 (2017), respectively.

AB - The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small-and large-molecule analysis involving LC-MS, hybrid ligand-binding assay (LBA)/LC-MS and LBA approaches. This 2017 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for large-molecule bioanalysis, biomarkers and immunogenicity using LBA. Part 1 (LC-MS for small molecules, peptides and small molecule biomarkers) and Part 2 (hybrid LBA/LC-MS for biotherapeutics and regulatory agencies' inputs) are published in volume 9 of Bioanalysis, issues 22 and 23 (2017), respectively.

KW - VALIDATION GROUP WORKSHOP

KW - REGULATORY AGENCIES

KW - 1-SMALL MOLECULES

KW - 2-HYBRID LBA/LCMS

KW - FULL IMMERSION

KW - DRUG QUANTIFICATION

KW - FOCUS

KW - RECOMMENDATIONS

KW - ANTIBODIES

KW - LCMS

U2 - 10.4155/bio-2017-4974

DO - 10.4155/bio-2017-4974

M3 - Article

VL - 9

SP - 1967

EP - 1996

JO - Bioanalysis

JF - Bioanalysis

SN - 1757-6180

IS - 24

ER -

ID: 79154331