2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

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

(2021) Xiaoxiao Huang et al.   AAPS Journal

Glycoform-resolved pharmacokinetic studies in a rat model employing glycoengineered variants of a therapeutic monoclonal antibody

(2021) David Falck et al.   mAbs

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

Cancer Immunotherapy Update: FDA-Approved Checkpoint Inhibitors and Companion Diagnostics

(2021) Julianne D. Twomey et al.   AAPS Journal

Maintaining ‘standards’ for biosimilar monoclonal antibodies

(2021) Sandra Prior et al.   NATURE BIOTECHNOLOGY

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

Bioanalysis and the oncology revolution

(2021) Enaksha R Wickremsinhe et al.   Bioanalysis

Apolipoprotein E Binding Drives Structural and Compositional Rearrangement of mRNA-Containing Lipid Nanoparticles

(2021) Federica Sebastiani et al.   ACS Nano

Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection

(2021) David S. Khoury et al.   NATURE MEDICINE

Blocking endothelial lipase with monoclonal antibody MEDI5884 durably increases high density lipoprotein in nonhuman primates and in a phase 1 trial

(2021) John E. Le Lay et al.   Science Translational Medicine

Differences in levels of phosphatidylinositols in healthy and stable Coronary Artery Disease subjects revealed by HILIC-MRM method with SERRF normalization

(2021) Yue Huang et al.   PLoS One

Why is it important to develop a critical reagent management strategy?

(2021) Naamah Maundrell   Bioanalysis

Analytical method validation for biomarkers as a drug development tool: points to consider

(2021) Yoshiaki Ohtsu et al.   Bioanalysis

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

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

LEGACY: Phase 2a Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of the Anti-EL (Endothelial Lipase) Antibody MEDI5884 in Patients With Stable Coronary Artery Disease

(2021) Christian T. Ruff et al.   ARTERIOSCLEROSIS THROMBOSIS AND VASCULAR BIOLOGY

Protein Biomarker Quantification by Immunoaffinity Liquid Chromatography–Tandem Mass Spectrometry: Current State and Future Vision

(2020) Hendrik Neubert et al.   CLINICAL CHEMISTRY

Pharmacokinetic Characterization and Tissue Distribution of Fusion Protein Therapeutics by Orthogonal Bioanalytical Assays and Minimal PBPK Modeling

(2020) Hiroshi Sugimoto et al.   MOLECULES

CRISPR-engineered T cells in patients with refractory cancer

(2020) Edward A. Stadtmauer et al.   SCIENCE

Generic MS-based method for the bioanalysis of therapeutic monoclonal antibodies in nonclinical studies

(2020) Noritaka Hashii et al.   Bioanalysis

IQ consortium perspective: complementary LBA and LC–MS in protein therapeutics bioanalysis and biotransformation assessment

(2020) Surinder Kaur et al.   Bioanalysis

Nicotinic acid transport into human liver involves organic anion transporter 2 (SLC22A7)

(2020) Sumathy Mathialagan et al.   BIOCHEMICAL PHARMACOLOGY

AAV-CRISPR Gene Editing Is Negated by Pre-existing Immunity to Cas9

(2020) Ang Li et al.   MOLECULAR THERAPY

Integration of Acoustic Liquid Handling into Quantitative Analysis of Biological Matrix Samples

(2020) Linna Wang et al.   SLAS Technology

A Multiplexed HILIC-MS/HRMS Assay for the Assessment of Transporter Inhibition Biomarkers in Phase I Clinical Trials: Isobutyryl-Carnitine as an Organic Cation Transporter (OCT1) Biomarker

(2020) Lina Luo et al.   ANALYTICAL CHEMISTRY

Top-Down Characterization of an Intact Monoclonal Antibody Using Activated Ion Electron Transfer Dissociation

(2020) Jean M. Lodge et al.   ANALYTICAL CHEMISTRY

Delivery of Oligonucleotides to the Liver with GalNAc: From Research to Registered Therapeutic Drug

(2020) Alexandre J. Debacker et al.   MOLECULAR THERAPY

Advances in oligonucleotide drug delivery

(2020) Thomas C. Roberts et al.   NATURE REVIEWS DRUG DISCOVERY

Hybrid LC–MS as a powerful tool for supporting protein bioanalysis in gene and cell therapies

(2020) Dong Wei et al.   Bioanalysis

Antipeptide Immunocapture with In-Sample Calibration Curve Strategy for Sensitive and Robust LC-MS/MS Bioanalysis of Clinical Protein Biomarkers in Formalin-Fixed Paraffin-Embedded Tumor Tissues

(2020) Naiyu Zheng et al.   ANALYTICAL CHEMISTRY

Current State of Oligonucleotide Characterization Using Liquid Chromatography–Mass Spectrometry: Insight into Critical Issues

(2020) J. Michael Sutton et al.   JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY

Intact Protein Mass Spectrometry for Therapeutic Protein Quantitation, Pharmacokinetics, and Biotransformation in Preclinical and Clinical Studies: An Industry Perspective

(2020) John F. Kellie et al.   JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY

Investigating the pharmacodynamic durability of GalNAc–siRNA conjugates

(2020) Christopher R Brown et al.   NUCLEIC ACIDS RESEARCH

A peptide immunoaffinity LC–MS/MS strategy for quantifying the GPCR protein, S1PR1 in human colon biopsies

(2020) Hongwei Zhang et al.   Bioanalysis

First‐in‐Human, Single‐ and Multiple‐Ascending‐Dose Studies in Healthy Subjects to Assess Pharmacokinetics, Pharmacodynamics, and Safety/Tolerability of Iberdomide, a Novel Cereblon E3 Ligase Modulator

(2020) Ying Ye et al.   Clinical Pharmacology in Drug Development

Proteomic Analysis of Exosomes for Discovery of Protein Biomarkers for Prostate and Bladder Cancer

(2020) Yi-Ting Wang et al.   Cancers

Identification of hnRNP-A1 as a pharmacodynamic biomarker of type I PRMT inhibition in blood and tumor tissues

(2020) Paul B. Noto et al.   Scientific Reports

Identification of preexisting adaptive immunity to Cas9 proteins in humans

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

Selective tissue targeting of synthetic nucleic acid drugs

(2019) Punit P. Seth et al.   JOURNAL OF CLINICAL INVESTIGATION

Systematic Error Removal Using Random Forest for Normalizing Large-Scale Untargeted Lipidomics Data

(2019) Sili Fan et al.   ANALYTICAL CHEMISTRY

Critical reagent screening and characterization: benefits and approaches for protein biomarker assays by hybrid LC–MS

(2019) Rasa Santockyte et al.   Bioanalysis

Perspectives on exploring hybrid LBA/LC–MS approach for clinical immunogenicity testing

(2019) Hao Jiang et al.   Bioanalysis

Best practice in reporting corona studies: Minimum information about Nanomaterial Biocorona Experiments (MINBE)

(2019) Andrew J. Chetwynd et al.   Nano Today

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

SampPick: Selection of a Cohort of Subjects Matching a Population HLA Distribution

(2019) Joseph R. McGill et al.   Frontiers in Immunology

Development of a general method for quantifying IgG-based therapeutic monoclonal antibodies in human plasma using protein G purification coupled with a two internal standard calibration strategy using LC-MS/MS

(2018) Huai-Hsuan Chiu et al.   ANALYTICA CHIMICA ACTA

Development and validation of a UPLC-MS method for the determination of galantamine in guinea pig plasma and its application to a pre-clinical bioavailability study of novel galantamine formulations

(2018) Jiang Wang et al.   BIOMEDICAL CHROMATOGRAPHY

RNA-Targeted Therapeutics

(2018) Stanley T. Crooke et al.   Cell Metabolism

LC–MS/MS assay for N1-methylnicotinamide in humans, an endogenous probe for renal transporters

(2018) Lina Luo et al.   Bioanalysis

Hybrid assays: the next big thing?

(2018) Brian P Booth et al.   Bioanalysis

Current Challenges in Delivery and Cytosolic Translocation of Therapeutic RNAs

(2018) Ludger Johannes et al.   Nucleic Acid Therapeutics

Antineoplastic Drug-Induced Cardiotoxicity: A Redox Perspective

(2018) Gilda Varricchi et al.   Frontiers in Physiology

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

High prevalence of Streptococcus pyogenes Cas9-reactive T cells within the adult human population

(2018) Dimitrios L. Wagner et al.   NATURE MEDICINE

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

Perspectives on potentiating immunocapture-LC–MS for the bioanalysis of biotherapeutics and biomarkers

(2018) Hiroshi Sugimoto 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

Optimizing hybrid LC–MS/MS binding conditions is critical: impact of biotransformation on quantification of trastuzumab

(2018) Luna Liu et al.   Bioanalysis

Insulin glargine and its two active metabolites: A sensitive (16 pM) and robust simultaneous hybrid assay coupling immunoaffinity purification with LC–MS/MS to support biosimilar clinical studies

(2017) Yang Xu et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Extracellular Vesicles as Biomarkers and Therapeutics in Dermatology: A Focus on Exosomes

(2017) Jeffrey D. McBride et al.   JOURNAL OF INVESTIGATIVE DERMATOLOGY

International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab

(2017) Sandra Prior et al.   mAbs

Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar

(2017) Seokkyun Kim et al.   mAbs

N- andO-glycosylation Analysis of Human C1-inhibitor Reveals Extensive Mucin-typeO-Glycosylation

(2017) Kathrin Stavenhagen et al.   MOLECULAR & CELLULAR PROTEOMICS

Impact of enhanced metabolic stability on pharmacokinetics and pharmacodynamics of GalNAc–siRNA conjugates

(2017) Jayaprakash K. Nair et al.   NUCLEIC ACIDS RESEARCH

Bridging immunogenicity assays for IgG4 therapeutics: mitigating interference from Fc–Fc interactions

(2017) Michael A Partridge et al.   Bioanalysis

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

Analytical considerations for quantitative LC–MS strategies for measuring antibody drug–target engagement in tissues

(2017) Petia Shipkova 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

Immunoaffinity LC–MS/MS for quantitative determination of a free and total protein target as a target engagement biomarker

(2017) Hongwei Zhang et al.   Bioanalysis

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

(2016) Bonnie Wu et al.   AAPS Journal

Comparing Various In Vitro Prediction Criteria to Assess the Potential of a New Molecular Entity to Inhibit Organic Anion Transporting Polypeptide 1B1

(2016) Jayabharathi Vaidyanathan et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Immuno-Oncology: The Third Paradigm in Early Drug Development

(2016) Juan Martin-Liberal et al.   Targeted Oncology

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

Validation of a biotherapeutic immunoaffinity-LC–MS/MS assay in monkey serum: ‘plug-and-play’ across seven molecules

(2016) Surinder Kaur et al.   Bioanalysis

Cells release subpopulations of exosomes with distinct molecular and biological properties

(2016) Eduard Willms et al.   Scientific Reports

Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective

(2015) Yow-Ming C. Wang et al.   AAPS Journal

N-glycan PK Profiling Using a High Sensitivity nanoLCMS Work-Flow with Heavy Stable Isotope Labeled Internal Standard and Application to a Preclinical Study of an IgG1 Biopharmaceutical

(2015) Fabian Higel et al.   PHARMACEUTICAL RESEARCH

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

Venous thrombosis

(2015) Alisa S. Wolberg et al.   Nature Reviews Disease Primers

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

Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics

(2014) Rand Jenkins et al.   AAPS Journal

Innovative Use of LC-MS/MS for Simultaneous Quantitation of Neutralizing Antibody, Residual Drug, and Human Immunoglobulin G in Immunogenicity Assay Development

(2014) Hao Jiang et al.   ANALYTICAL CHEMISTRY

Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: A phase II, randomized, controlled study

(2014) Roman Chlibek et al.   VACCINE

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

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

(2013) Marian Kelley et al.   AAPS Journal

Biosimilars in rheumatology: the wind of change

(2013) Christian K Schneider   ANNALS OF THE RHEUMATIC DISEASES

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

(2013) Lauren Stevenson et al.   Bioanalysis

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

(2012) Binodh DeSilva et al.   Bioanalysis

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)

(2012) Steve Lowes et al.   Bioanalysis

Characterization of Autologous Mesenchymal Stem Cell-Derived Neural Progenitors as a Feasible Source of Stem Cells for Central Nervous System Applications in Multiple Sclerosis

(2012) Violaine K. Harris et al.   Stem Cells Translational Medicine

Acceptable changes in quality attributes of glycosylated biopharmaceuticals

(2011) Martin Schiestl et al.   NATURE BIOTECHNOLOGY

Understanding and mitigating impact of immunogenicity on pharmacokinetic assays

(2011) Joleen T White et al.   Bioanalysis

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

(2011) Fabio Garofolo et al.   Bioanalysis

RNA Targeting Therapeutics: Molecular Mechanisms of Antisense Oligonucleotides as a Therapeutic Platform

(2010) C. Frank Bennett et al.   Annual Review of Pharmacology and Toxicology

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

(2010) Natasha Savoie et al.   Bioanalysis

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