2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2-hybrid LBA/LCMS and input from regulatory agencies)

被引：42

作者：

Ackermann, Brad ^{[1
]}

Neubert, Hendrik ^{[2
]}

Hughes, Nicola ^{[3
]}

Garofolo, Fabio ^{[4
]}

Abberley, Lee ^{[5
]}

Alley, Stephen C. ^{[6
]}

Brown-Augsburger, Patricia ^{[1
]}

Bustard, Mark ^{[7
]}

Chen, Lin-zhi ^{[8
]}

Heinrich, Julia ^{[9
]}

Katori, Noriko ^{[10
]}

Kaur, Surinder ^{[11
]}

Kirkovsky, Leo ^{[12
]}

Laterza, Omar F. ^{[13
]}

Le Blaye, Olivier ^{[14
]}

Levesque, Ann ^{[15
]}

Lima Santos, Gustavo Mendes ^{[16
]}

Olah, Timothy ^{[17
]}

Savoie, Natasha ^{[18
]}

Skelly, Michael ^{[19
]}

Spitz, Susan ^{[20
]}

Szapacs, Matthew ^{[5
]}

Tampal, Nilufer ^{[19
]}

Wang, Jian ^{[17
]}

Welink, Jan ^{[21
]}

Wieling, Jaap ^{[22
]}

Haidar, Sam ^{[19
]}

Vinter, Stephen ^{[23
]}

Whale, Emma ^{[23
]}

Witte, Baerbel ^{[24
]}

机构：

[1] Eli Lilly & Co, Indianapolis, IN 46285 USA

[2] Pfizer, Andover, MA USA

[3] Bioanalyt Lab Serv, Toronto, ON, Canada

[4] Angelini Pharma, I-0040 S Palomba Pomezia, RM, Italy

[5] GlaxoSmithKline, King Of Prussia, PA USA

[6] Seattle Genet, Seattle, WA USA

[7] Hlth Canada, Ottawa, ON K1A 0L2, Canada

[8] Boehringer Ingelheim KG, Ridgefield, CT USA

[9] pRED Pharmaceut Sci, Roche Innovat Ctr Penzberg, Berlin, Germany

[10] Japan MHLW NIHS, Tokyo, Japan

[11] Genentech Inc, San Francisco, CA 94080 USA

[12] Pfizer, San Diego, CA USA

[13] Merck & Co Inc, Rahway, NJ 07065 USA

[14] France ANSM, St Denis, France

[15] InVentiv Hlth Clin, Quebec City, PQ, Canada

[16] Brazil ANVISA, Brasilia, DF, Brazil

[17] Bristol Myers Squibb Co, Princeton, NJ USA

[18] CFABS, Montreal, PQ, Canada

[19] US FDA, Silver Spring, MD USA

[20] MedImmune, Gaithersburg, MD USA

[21] Dutch MEB, Utrecht, Netherlands

[22] Antaeus Biopharma, Fochteloo, Netherlands

[23] UK MHRA, London, England

[24] Germany BfArM, Bonn, Germany

来源：

BIOANALYSIS | 2015年 / 7卷 / 23期

关键词：

VALIDATION GROUP WORKSHOP; LC-MS/MS; FULL IMMERSION; MASS-SPECTROMETRY; PROTEIN; IMMUNOGENICITY; GLUCAGON; ANTIBODY; DRUG; QUANTIFICATION;

D O I：

10.4155/bio.15.214

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. It is once again a 5-day week long event - a full immersion bioanalytical week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations that emerged from the extensive discussions held during the workshop, and is aimed at providing the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to advance scientific excellence, improve quality and deliver better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 2 covers the recommendations for hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in volume 7 of Bioanalysis, issues 22 and 24, respectively.

引用

页码：3019 / 3034

页数：16

共 31 条

[1]

Abberley L., 2015, 9 WORKSH REC ISS BIO

[2] Hyperglucagonaemia analysed by glucagon sandwich ELISA: nonspecific interference or truly elevated levels? [J].

Albrechtsen, Nicolai J. Wewer ;

Hartmann, Bolette ;

Veedfald, Simon ;

Windelov, Johanne A. ;

Plamboeck, Astrid ;

Bojsen-Moller, Kirstine N. ;

Idorn, Thomas ;

Feldt-Rasmussen, Bo ;

Knop, Filip K. ;

Vilsboll, Tina ;

Madsbad, Sten ;

Deacon, Carolyn F. ;

Holst, Jens J. .

DIABETOLOGIA, 2014, 57 (09) :1919-1926

[3]

[Anonymous], 2010, REFL PAP EXP EL SOUR

[4]

[Anonymous], 2015, MHRA GMP DAT INT DEF

[5]

[Anonymous], 2011, Science Medicines Health, Guideline on bioanalytical method validation.

[6]

[Anonymous], 2013, REFL PAP GCP COMPL R

[7] Specificity and sensitivity of commercially available assays for glucagon and oxyntomodulin measurement in humans [J].

Bak, Monika J. ;

Albrechtsen, Nicolai Wewer ;

Pedersen, Jens ;

Hartmann, Bolette ;

Christensen, Mikkel ;

Vilsboll, Tina ;

Knop, Filip K. ;

Deacon, Carolyn F. ;

Dragsted, Lars O. ;

Holst, Jens J. .

EUROPEAN JOURNAL OF ENDOCRINOLOGY, 2014, 170 (04) :529-538

[8] Quantification of NTproBNP in rat serum using immunciprecipitation and LC/MS/MS: a biomarker of drug-induced cardiac hypertrophy [J].

Berna, Michael ;

Ott, Lee ;

Engle, Steve ;

Watson, David ;

Solter, Philip ;

Ackermann, Bradley .

ANALYTICAL CHEMISTRY, 2008, 80 (03) :561-566

[9] Workshop Report: Crystal City V-Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance [J].

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, Michael ;

Stevenson, Lauren ;

Subramaniam, Sriram ;

Weiner, Russell ;

Woolf, Eric .

AAPS JOURNAL, 2015, 17 (02) :277-288

[10] Utilizing LC-MS/MS to provide adaptable clinical bioanalytical support for an extended half-life bioactive peptide fused to an albumin-binding domain antibody [J].

Bowen, Chester L. ;

Kehler, Jonathan ;

Mencken, Thomas ;

Orr, Bonnie ;

Szapacs, Matthew .

ANALYTICAL METHODS, 2015, 7 (01) :237-243

← 1 2 3 4 →