2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)

In Vivo Cellular Expansion of Lisocabtagene Maraleucel and Association With Efficacy and Safety in Relapsed/Refractory Large B‐Cell Lymphoma

(2022) Ken Ogasawara et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Isotyping and Semi-Quantitation of Monkey Anti-Drug Antibodies by Immunocapture Liquid Chromatography-Mass Spectrometry

(2021) Xiaoxiao Huang et al.   AAPS Journal

2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 – Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)

(2021) Hendrik Neubert et al.   Bioanalysis

Immunogenicity of CAR T cells in cancer therapy

(2021) Dimitrios L. Wagner et al.   Nature Reviews Clinical Oncology

2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

(2021) Susan Spitz et al.   Bioanalysis

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)

(2021) Bart Corsaro et al.   Bioanalysis

Assay concept for detecting anti-drug IgM in human serum samples by using a novel recombinant human IgM positive control

(2021) Christian Künzel et al.   Bioanalysis

Quantification of SARS-CoV-2 neutralizing antibody by wild-type plaque reduction neutralization, microneutralization and pseudotyped virus neutralization assays

(2021) Kevin R. Bewley et al.   Nature Protocols

An Alternative Data Transformation Approach for ADA Cut Point Determination: Why Not Use a Weibull Transformation?

(2021) Gregor Jordan et al.   AAPS Journal

CRISPR-Cas9 In Vivo Gene Editing for Transthyretin Amyloidosis

(2021) Julian D. Gillmore et al.   NEW ENGLAND JOURNAL OF MEDICINE

Cas9-derived peptides presented by MHC Class II that elicit proliferation of CD4+ T-cells

(2021) Vijaya L. Simhadri et al.   Nature Communications

Tisagenlecleucel Immunogenicity in Relapsed/Refractory Acute Lymphoblastic Leukemia and Diffuse Large B-Cell Lymphoma

(2021) Karen Thudium Mueller et al.   Blood Advances

Anti-drug Antibody Validation Testing and Reporting Harmonization

(2021) Heather Myler et al.   AAPS Journal

Safety and feasibility of anti-CD19 CAR T cells with fully human binding domains in patients with B-cell lymphoma

(2020) Jennifer N. Brudno et al.   NATURE MEDICINE

In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report

(2020) Sandra Suarez-Sharp et al.   AAPS Journal

IgG-cleaving endopeptidase enables in vivo gene therapy in the presence of anti-AAV neutralizing antibodies

(2020) Christian Leborgne et al.   NATURE MEDICINE

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

(2020) Olaf Broders et al.   Bioanalysis

Design and Evaluation of a Multiplexed Assay to Assess Human Immunogenicity Against Humira®

(2020) Matthew Alleyn et al.   AAPS Journal

A SARS-CoV-2 surrogate virus neutralization test based on antibody-mediated blockage of ACE2–spike protein–protein interaction

(2020) Chee Wah Tan et al.   NATURE BIOTECHNOLOGY

Mapping functional humoral correlates of protection against malaria challenge following RTS,S/AS01 vaccination

(2020) Todd J. Suscovich et al.   Science Translational Medicine

Toward comparability of anti-drug antibody assays: is the amount of anti-drug antibody–reagent complexes at cut-point (CP-ARC) the missing piece?

(2020) Gregor Jordan et al.   Bioanalysis

Systemic nanoparticle delivery of CRISPR-Cas9 ribonucleoproteins for effective tissue specific genome editing

(2020) Tuo Wei et al.   Nature Communications

Entinostat plus pembrolizumab in patients with metastatic NSCLC previously treated with anti-PD-(L)1 therapy

(2020) Matthew D. Hellmann et al.   CLINICAL CANCER RESEARCH

Epitope characterization of anti-drug antibodies—a tool for discovery and health: an overview of the necessity of early epitope characterization to avoid anti-drug antibodies and promote patient health

(2020) Matthew McMaster et al.   EXPERT OPINION ON BIOLOGICAL THERAPY

qPCR and qRT-PCR analysis: Regulatory points to consider when conducting biodistribution and vector shedding studies

(2020) Haiyan Ma et al.   Molecular Therapy-Methods & Clinical Development

Inflammatory parameters associated with systemic reactogenicity following vaccination with adjuvanted hepatitis B vaccines in humans

(2019) Wivine Burny et al.   VACCINE

Identification of preexisting adaptive immunity to Cas9 proteins in humans

(2019) Carsten T. Charlesworth et al.   NATURE MEDICINE

Immunogenicity of Chimeric Antigen Receptor T-Cell Therapeutics

(2019) Boris Gorovits et al.   BIODRUGS

Exploratory trial of a biepitopic CAR T-targeting B cell maturation antigen in relapsed/refractory multiple myeloma

(2019) Jie Xu et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Comparison between a new multiplex electrochemiluminescence assay and the WHO reference enzyme-linked immunosorbent assay to measure serum antibodies against pneumococcal serotype-specific polysaccharides

(2019) Muriel Feyssaguet et al.   VACCINE

Therapeutic hFIX activity achieved after single AAV5-hFIX treatment in hemophilia B patients and NHPs with pre-existing anti-AAV5 NABs

(2019) Anna Majowicz et al.   Molecular Therapy-Methods & Clinical Development

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

The Impact of Pre-existing Immunity on the Non-clinical Pharmacodynamics of AAV5-Based Gene Therapy

(2019) Brian R. Long et al.   Molecular Therapy-Methods & Clinical Development

Prevalence of Anti-Adeno-Associated Virus Immune Responses in International Cohorts of Healthy Donors

(2019) Anita Kruzik et al.   Molecular Therapy-Methods & Clinical Development

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

(2019) Boris Gorovits et al.   BIODRUGS

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

Bioanalysis of adeno-associated virus gene therapy therapeutics: regulatory expectations

(2019) Boris Gorovits et al.   Bioanalysis

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

Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs

(2019) Francesca Civoli et al.   AAPS Journal

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

Analysis of regulatory guidance on antidrug antibody testing for therapeutic protein products

(2019) Nazneen Bano et al.   Bioanalysis

A minimal physiologically based pharmacokinetic model that predicts anti-PEG IgG-mediated clearance of PEGylated drugs in human and mouse

(2018) M.D. McSweeney et al.   JOURNAL OF CONTROLLED RELEASE

Adjuvant-Associated Peripheral Blood mRNA Profiles and Kinetics Induced by the Adjuvanted Recombinant Protein Candidate Tuberculosis Vaccine M72/AS01 in Bacillus Calmette–Guérin-Vaccinated Adults

(2018) Robert A. van den Berg et al.   Frontiers in Immunology

Influence of Pre-existing Anti-capsid Neutralizing and Binding Antibodies on AAV Vector Transduction

(2018) Zachary Fitzpatrick et al.   Molecular Therapy-Methods & Clinical Development

Prevalence of Pre-existing Antibodies to CRISPR-Associated Nuclease Cas9 in the USA Population

(2018) Vijaya L. Simhadri et al.   Molecular Therapy-Methods & Clinical Development

Virus Reduction Neutralization Test: A Single-Cell Imaging High-Throughput Virus Neutralization Assay for Dengue

(2018) Melissa C. Whiteman et al.   AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE

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

Development of a Chemiluminescent ELISA Method for the Detection of Total Anti-Adeno Associated Virus Serotype 9 (AAV9) Antibodies

(2018) Uma Kavita et al.   Human Gene Therapy Methods

Strategy to detect pre-existing immunity to AAV gene therapy

(2017) L Falese et al.   GENE THERAPY

Unraveling the Complex Story of Immune Responses to AAV Vectors Trial After Trial

(2017) Céline Vandamme et al.   HUMAN GENE THERAPY

Evaluation of a Novel Reporter Virus Neutralization Test for Serological Diagnosis of Zika and Dengue Virus Infection

(2017) Chao Shan et al.   JOURNAL OF CLINICAL MICROBIOLOGY

A biotin-drug extraction and acid dissociation (BEAD) procedure to eliminate matrix and drug interference in a protein complex anti-drug antibody (ADA) isotype specific assay

(2017) Hongmei Niu et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Inhibiting Plasma Kallikrein for Hereditary Angioedema Prophylaxis

(2017) Aleena Banerji 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

Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach

(2017) Janka Ryding 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

Pre-existing Antibody: Biotherapeutic Modality-Based Review

(2016) Boris Gorovits et al.   AAPS Journal

High Prevalence of Infectious Adeno-associated Virus (AAV) in Human Peripheral Blood Mononuclear Cells Indicative of T Lymphocytes as Sites of AAV Persistence

(2016) Daniela Hüser et al.   JOURNAL OF VIROLOGY

Novel human IgG1 and IgG4 Fc-engineered antibodies with completely abolished immune effector functions

(2016) Tilman Schlothauer et al.   PROTEIN ENGINEERING DESIGN & SELECTION

Immunotherapy of non-Hodgkin’s lymphoma with a defined ratio of CD8 + and CD4 + CD19-specific chimeric antigen receptor–modified T cells

(2016) Cameron J. Turtle et al.   Science Translational Medicine

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

Recent Advances in Assessing Immunogenicity of Therapeutic Proteins: Impact on Biotherapeutic Development

(2016) Yanmei Lu et al.   Journal of Immunology Research

Early Rise of Blood T Follicular Helper Cell Subsets and Baseline Immunity as Predictors of Persisting Late Functional Antibody Responses to Vaccination in Humans

(2016) Fabiana Spensieri et al.   PLoS One

A breakthrough novel method to resolve the drug and target interference problem in immunogenicity assays

(2015) Jad Zoghbi et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Epitope characterization of the ADA response directed against a targeted immunocytokine

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

Treatment of CD33-directed Chimeric Antigen Receptor-modified T Cells in One Patient With Relapsed and Refractory Acute Myeloid Leukemia

(2015) Quan-shun Wang et al.   MOLECULAR THERAPY

Immunogenicity of idursulfase and clinical outcomes in very young patients (16 months to 7.5 years) with mucopolysaccharidosis II (Hunter syndrome)

(2015) Arian Pano et al.   Orphanet Journal of Rare Diseases

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

Systems vaccinology: Probing humanity's diverse immune systems with vaccines

(2014) B. Pulendran   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Guidelines for validation of qualitative real-time PCR methods

(2014) S. Broeders et al.   TRENDS IN FOOD SCIENCE & TECHNOLOGY

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

An electrochemiluminescence (ECL)-based assay for the specific detection of anti-drug antibodies of the IgE isotype

(2013) Yuling Wu et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

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

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

(2012) Binodh DeSilva et al.   Bioanalysis

Impact of Pre-Existing Immunity on Gene Transfer to Nonhuman Primate Liver with Adeno-Associated Virus 8 Vectors

(2011) Lili Wang et al.   HUMAN GENE THERAPY

T Cell Activation by Terminal Complex of Complement and Immune Complexes

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

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

Antitransgene Rejection Responses Contribute to Attenuated Persistence of Adoptively Transferred CD20/CD19-Specific Chimeric Antigen Receptor Redirected T Cells in Humans

(2010) Michael C. Jensen et al.   BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION

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

(2010) Natasha Savoie et al.   Bioanalysis

Evaluation of a biosensor immunoassay for simultaneous characterization of isotype and binding region of human anti-tocilizumab antibodies with control by surrogate standards

(2009) Kay Stubenrauch et al.   ANALYTICAL BIOCHEMISTRY

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

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

Checklist for optimization and validation of real-time PCR assays

(2009) Marijke Raymaekers et al.   JOURNAL OF CLINICAL LABORATORY ANALYSIS

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