2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity)

Bispecific antibodies

(2015) Roland E. Kontermann et al.   DRUG DISCOVERY TODAY

A fit-for-purpose strategy for the risk-based immunogenicity testing of biotherapeutics: a European industry perspective

(2015) Cathelijne Kloks et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Alternative molecular formats and therapeutic applications for bispecific antibodies

(2015) Christoph Spiess et al.   MOLECULAR IMMUNOLOGY

Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development

(2015) Masood U Khan et al.   Bioanalysis

Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team

(2014) Lindsay E. King et al.   AAPS Journal

A White Paper—Consensus and Recommendations of a Global Harmonization Team on Assessing the Impact of Immunogenicity on Pharmacokinetic Measurements

(2014) J. M. Sailstad et al.   AAPS Journal

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

(2014) G. Shankar et al.   AAPS Journal

Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics

(2014) Boris Gorovits et al.   JOURNAL OF IMMUNOLOGICAL METHODS

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1 – small molecules by LCMS)

(2014) Eric Fluhler et al.   Bioanalysis

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input)

(2014) Dawn Dufield et al.   Bioanalysis

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

(2014) Lauren Stevenson et al.   Bioanalysis

Life cycle management of critical ligand-binding reagents

(2013) Denise M O'Hara et al.   Bioanalysis

Characterization of critical reagents in ligand-binding assays: enabling robust bioanalytical methods and lifecycle management

(2013) Brian J Geist et al.   Bioanalysis

2013 White Paper on recent issues in bioanalysis: ‘hybrid’ – the best of LBA and LCMS

(2013) Lauren Stevenson et al.   Bioanalysis

Ligand Binding Assays in the 21st Century Laboratory: Recommendations for Characterization and Supply of Critical Reagents

(2012) Denise M. O’Hara et al.   AAPS Journal

Stratification of Antibody-Positive Subjects by Antibody Level Reveals an Impact of Immunogenicity on Pharmacokinetics

(2012) Lei Zhou et al.   AAPS Journal

Measurement of Anti-Erythropoiesis-Stimulating Agent IgG4 Antibody as an Indicator of Antibody-Mediated Pure Red Cell Aplasia

(2012) Dohan K. Weeraratne et al.   Clinical and Vaccine Immunology

2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines

(2012) Binodh DeSilva et al.   Bioanalysis

Summary of Confirmation Cut Point Discussions

(2011) Holly W. Smith et al.   AAPS Journal

Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development

(2011) Jean W. Lee et al.   AAPS Journal

The impact of antibodies on clinical outcomes in diseases treated with therapeutic protein: Lessons learned from infantile Pompe disease

(2011) Suhrad G. Banugaria et al.   GENETICS IN MEDICINE

Development of Antidrug Antibodies Against Adalimumab and Association With Disease Activity and Treatment Failure During Long-term Follow-up

(2011) Geertje M. Bartelds   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Quality requirements for critical assay reagents used in bioanalysis of therapeutic proteins: what bioanalysts should know about their reagents

(2011) Roland F Staack et al.   Bioanalysis

2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

(2011) Fabio Garofolo et al.   Bioanalysis

Effect of hemolysis on insulin determination by the Beckman Coulter Unicell DXI 800 immunoassay analyzer

(2010) Paul R. Cook et al.   CLINICAL BIOCHEMISTRY

High avidity cytokine autoantibodies in health and disease: Pathogenesis and mechanisms

(2010) Masato Watanabe et al.   CYTOKINE & GROWTH FACTOR REVIEWS

Solution ELISA as a platform of choice for development of robust, drug tolerant immunogenicity assays in support of drug development

(2010) Alvydas Mikulskis et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Systematic analytical validation of commercial kits for the determination of novel biomarkers for clinical drug development

(2010) William Nowatzke et al.   Bioanalysis

2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance

(2010) Natasha Savoie et al.   Bioanalysis

The Uses of Biomarkers in Drug Development

(2009) Orest Hurko   Annals of the New York Academy of Sciences

The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis

(2009) Natasha Savoie et al.   Bioanalysis

2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

(2009) Natasha Savoie et al.   Bioanalysis

Assessing Immunogenicity in the Presence of Excess Protein Therapeutic Using Immunoprecipitation and Quantitative Mass Spectrometry

(2008) Hendrik Neubert et al.   ANALYTICAL CHEMISTRY

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

(2008) Gopi Shankar et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS