How the bioanalytical scientist plays a key role in interdisciplinary project teams in the development of biotherapeutics: a reflection of the European Bioanalysis Forum

被引：7

作者：

Dudal, Sherri ^{[1
]}

Staack, Roland F. ^{[2
]}

Stoellner, Daniela ^{[3
]}

Fjording, Marianne Scheel ^{[4
]}

Vieser, Eva ^{[5
]}

Pascual, Marie-Helene ^{[6
]}

Brudny-Kloeppel, Margarete ^{[7
]}

Golob, Michaela ^{[8
]}

机构：

[1] DMPK & Bioanalyt R&D, Roche Innovat Ctr Basel, Pharmaceut Sci, Basel, Switzerland

[2] DMPK & Bioanalyt R&D, Roche Innovat Ctr Penzberg, Pharmaceut Sci, Darmstadt, Germany

[3] DMPK Biol, Novartis Inst Biomed Res, Novartis Pharma AG, CH-4002 Basel, Switzerland

[4] Novo Nordisk AS, DK-2760 Malov, Denmark

[5] AMGEN Res Munich GmbH, Bioanalyt PK PD, D-81477 Munich, Germany

[6] Sanofi, Biomarkers & Biol Anal Grp Disposit Safety & Anim, Sanofi Rech & Dev, F-94140 Alfortville, France

[7] Bayer Pharma AG, Drug Metab & Pharmacokinet, Bioanalyt & Nonclin Pharmacokinet, CRO Monitoring Bioanalyt, D-13342 Berlin, Germany

[8] Merck Serono, DMPK Inst Drug Metab & Pharmacokinet, D-85567 Grafing, Germany

来源：

BIOANALYSIS | 2014年 / 6卷 / 10期

关键词：

assay development; bioanalysis; bioanalytical process; biotherapeutics; clinical; drug development; large molecules; preclinical; project team; sample analysis; LIGAND-BINDING ASSAYS; IMMUNOGENICITY ASSAYS; TARGET INTERFERENCE; CRITICAL REAGENTS; DRUG DEVELOPMENT; SERUM SAMPLES; SUPPORT; QUANTIFICATION; IMMUNOASSAY; ANTIBODIES;

D O I：

10.4155/bio.14.90

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

The bioanalytical scientist plays a key role in the project team for the drug development of biotherapeutics from the discovery to the marketing phase. Information from the project team members is required for assay development and sample analysis during the discovery, preclinical and clinical phases of the project and input is needed from the bioanalytical scientist to help data interpretation. The European Bioanalysis Forum target team 20 discussed many of the gaps in information and communication between the bioanalytical scientist and project team members as a base for providing a perspective on the bioanalytical scientist's role and interactions within the project team.

引用

页码：1339 / 1348

页数：10

共 19 条

[1]

Carrasco-Triguero M, 2012, BIOANALYSIS, V4, P2013, DOI [10.4155/bio.12.165, 10.4155/BIO.12.165]

[2]

Diamandis E.P., 1996, IMMUNOASSAY

[3]

Dijksman J, 2012, BIOANALYSIS, V4, P2769, DOI [10.4155/bio.12.273, 10.4155/BIO.12.273]

[4]

Geist BJ, 2013, BIOANALYSIS, V5, P227, DOI [10.4155/BIO.12.304, 10.4155/bio.12.304]

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

Kelley, Marian ;

Ahene, Ago B. ;

Gorovits, Boris ;

Kamerud, John ;

King, Lindsay E. ;

McIntosh, Thomas ;

Yang, Jihong .

AAPS JOURNAL, 2013, 15 (03) :646-658

[6] Bioanalytical Approaches to Quantify "Total" and "Free" Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development [J].

Lee, Jean W. ;

Kelley, Marian ;

King, Lindsay E. ;

Yang, Jihong ;

Salimi-Moosavi, Hossein ;

Tang, Meina T. ;

Lu, Jian-Feng ;

Kamerud, John ;

Ahene, Ago ;

Myler, Heather ;

Rogers, Cindy .

AAPS JOURNAL, 2011, 13 (01) :99-110

[7] On Setting the First Dose in Man: Quantitating Biotherapeutic Drug-Target Binding through Pharmacokinetic and Pharmacodynamic Models [J].

Lowe, Philip J. ;

Tannenbaum, Stacey ;

Wu, Kai ;

Lloyd, Peter ;

Sims, Jennifer .

BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY, 2010, 106 (03) :195-209

[8] Solution ELISA as a platform of choice for development of robust, drug tolerant immunogenicity assays in support of drug development [J].

Mikulskis, Alvydas ;

Yeung, Dave ;

Subramanyam, Meena ;

Amaravadi, Lakshmi .

JOURNAL OF IMMUNOLOGICAL METHODS, 2011, 365 (1-2) :38-49

[9] The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies [J].

Muller, Patrick Y. ;

Milton, Mark ;

Lloyd, Peter ;

Sims, Jennifer ;

Brennan, Frank R. .

CURRENT OPINION IN BIOTECHNOLOGY, 2009, 20 (06) :722-729

[10] Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs [J].

Nowatzke, William L. ;

Rogers, Kathryn ;

Wells, Edward ;

Bowsher, Ronald R. ;

Ray, Chad ;

Unger, Steve .

BIOANALYSIS, 2011, 3 (05) :509-521

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