2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 – Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)

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

(2020) Boris Gorovits et al.   AAPS Journal

Confirmatory cut point has limited ability to make accurate classifications in immunogenicity assays

(2020) Robert J Kubiak et al.   Bioanalysis

Novel bioanalytical method for the characterization of the immune response directed against a bispecific F(ab) fragment

(2020) Olaf Broders et al.   Bioanalysis

A new method for identification of outliers in immunogenicity assay cut point data

(2020) Jianchun Zhang et al.   JOURNAL OF IMMUNOLOGICAL METHODS

T-Cell Dependent Immunogenicity of Protein Therapeutics Pre-clinical Assessment and Mitigation–Updated Consensus and Review 2020

(2020) Vibha Jawa et al.   Frontiers in Immunology

Compatibility of immunogenicity guidance by the EMA and the US FDA

(2019) Pekka Kurki   Bioanalysis

Adeno-associated virus vector as a platform for gene therapy delivery

(2019) Dan Wang et al.   NATURE REVIEWS DRUG DISCOVERY

Immunogenicity of Chimeric Antigen Receptor T-Cell Therapeutics

(2019) Boris Gorovits et al.   BIODRUGS

Bispecific antibodies: a mechanistic review of the pipeline

(2019) Aran F. Labrijn et al.   NATURE REVIEWS DRUG DISCOVERY

Generation, Characterization, and Quantitative Bioanalysis of Drug/Anti-drug Antibody Immune Complexes to Facilitate Dedicated In Vivo Studies

(2019) Eugenia Hoffmann et al.   PHARMACEUTICAL RESEARCH

Current Considerations on Characterization of Immune Response to Multi-Domain Biotherapeutics

(2019) Boris Gorovits et al.   BIODRUGS

Guidelines for the use of flow cytometry and cell sorting in immunological studies (second edition)

(2019) Andrea Cossarizza et al.   EUROPEAN JOURNAL OF IMMUNOLOGY

A cell-based immunogenicity assay to detect antibodies against chimeric antigen receptor expressed by tisagenlecleucel

(2019) Bernd Potthoff et al.   JOURNAL OF IMMUNOLOGICAL METHODS

A novel approach to assess domain specificity of anti-drug antibodies to moxetumomab pasudotox, an immunotoxin with two functional domains

(2019) Inna Vainshtein et al.   JOURNAL OF IMMUNOLOGICAL METHODS

2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 – Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis)

(2019) Christine Fandozzi et al.   Bioanalysis

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

(2019) Brian Booth et al.   Bioanalysis

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

(2019) Steven Piccoli et al.   Bioanalysis

Selection of a Ligand-Binding Neutralizing Antibody Assay for Benralizumab: Comparison with an Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) Cell-Based Assay

(2018) Yuling Wu et al.   AAPS Journal

Restricted immune activation and internalisation of anti-idiotype complexes between drug and antidrug antibodies

(2018) Karin A van Schie et al.   ANNALS OF THE RHEUMATIC DISEASES

Development and characterization of an anti-rituximab monoclonal antibody panel

(2018) Minoru Tada et al.   mAbs

Excessive outlier removal may result in cut points that are not suitable for immunogenicity assessments

(2018) Robert J. Kubiak et al.   JOURNAL OF IMMUNOLOGICAL METHODS

2018 White Paper on Recent Issues in Bioanalysis: ‘A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)’ (Part 1 – small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis)

(2018) Jan Welink et al.   Bioanalysis

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays)

(2018) Lauren Stevenson et al.   Bioanalysis

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity)

(2018) Hendrik Neubert et al.   Bioanalysis

Association of immune response with efficacy and safety outcomes in adults with phenylketonuria administered pegvaliase in phase 3 clinical trials

(2018) Soumi Gupta et al.   EBioMedicine

Antibodies that neutralize cellular uptake of elosulfase alfa are not associated with reduced efficacy or pharmacodynamic effect in individuals with Morquio A syndrome

(2017) Andrew C. Melton et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Immunogenicity assessment during the development of protein therapeutics

(2017) Amy S. Rosenberg et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

AAV5–Factor VIII Gene Transfer in Severe Hemophilia A

(2017) Savita Rangarajan et al.   NEW ENGLAND JOURNAL OF MEDICINE

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)

(2017) Shalini Gupta et al.   Bioanalysis

The Decennial Index of the White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

(2017) Wei Garofolo et al.   Bioanalysis

2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies’ inputs)

(2017) Hendrik Neubert et al.   Bioanalysis

2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines ‘Scientific’? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers)

(2017) Jan Welink et al.   Bioanalysis

Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics

(2016) Bonnie Wu et al.   AAPS Journal

Treatment of metastatic renal cell carcinoma (mRCC) with CAIX CAR-engineered T-cells-a completed study overview

(2016) C. H. J. Lamers et al.   BIOCHEMICAL SOCIETY TRANSACTIONS

Immunogenicity, Inflammation, and Lipid Accumulation in Cynomolgus Monkeys Infused with a Lipidated Tetranectin-ApoA-I Fusion Protein

(2016) Franziska Regenass-Lechner et al.   TOXICOLOGICAL SCIENCES

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity)

(2016) Susan Richards et al.   Bioanalysis

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 – small molecules, peptides and small molecule biomarkers by LCMS)

(2016) Eric Yang et al.   Bioanalysis

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 – Hybrid LBA/LCMS and input from regulatory agencies)

(2016) An Song et al.   Bioanalysis

Immunogenicity to Biotherapeutics – The Role of Anti-drug Immune Complexes

(2016) Murli Krishna et al.   Frontiers in Immunology

Epitope characterization of the ADA response directed against a targeted immunocytokine

(2015) Kay Stubenrauch et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Guidelines for the automated evaluation of Elispot assays

(2015) Sylvia Janetzki et al.   Nature Protocols

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

(2015) Brad Ackermann et al.   Bioanalysis

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 – small molecules by LCMS)

(2015) Jan Welink et al.   Bioanalysis

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

(2015) Lakshmi Amaravadi et al.   Bioanalysis

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

Stability of anti-immunotherapeutic antibodies in frozen human serum samples

(2014) Lydia Michaut et al.   Bioanalysis

Stability studies of binding and functional anti-vaccine antibodies

(2014) Jenny Hendriks 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

The Digital MIQE Guidelines: Minimum Information for Publication of Quantitative Digital PCR Experiments

(2013) J. F. Huggett et al.   CLINICAL CHEMISTRY

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

(2013) Lauren Stevenson et al.   Bioanalysis

Immunogenicity testing strategy and bioanalytical assays for antibody–drug conjugates

(2013) Sarah A Hoofring et al.   Bioanalysis

Adalimumab elicits a restricted anti-idiotypic antibody response in autoimmune patients resulting in functional neutralisation

(2012) Pauline A van Schouwenburg et al.   ANNALS OF THE RHEUMATIC DISEASES

Prevalence and pharmacological modulation of humoral immunity to AAV vectors in gene transfer to synovial tissue

(2012) F Mingozzi et al.   GENE THERAPY

Correlation of screening and confirmatory results in tiered immunogenicity testing by solution-phase bridging assays

(2012) Robert J. Kubiak et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Quality assurance for polychromatic flow cytometry using a suite of calibration beads

(2012) Stephen P Perfetto et al.   Nature Protocols

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

(2012) Binodh DeSilva et al.   Bioanalysis

Adeno-Associated Virus Antibody Profiles in Newborns, Children, and Adolescents

(2011) Roberto Calcedo et al.   Clinical and Vaccine Immunology

T Cell Activation by Terminal Complex of Complement and Immune Complexes

(2011) Anil K. Chauhan et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

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

(2011) Fabio Garofolo et al.   Bioanalysis

Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics

(2010) Deborah Finco et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

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

(2010) Natasha Savoie et al.   Bioanalysis

The MIQE Guidelines: Minimum Information for Publication of Quantitative Real-Time PCR Experiments

(2009) S. A. Bustin et al.   CLINICAL CHEMISTRY

Worldwide Epidemiology of Neutralizing Antibodies to Adeno‐Associated Viruses

(2009) Roberto Calcedo et al.   JOURNAL OF INFECTIOUS DISEASES

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

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