Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

Aggregation risk prediction for antibodies and its application to biotherapeutic development

(2015) Olga Obrezanova et al.   mAbs

Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012

(2014) Leonard V. Sacks et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein

(2014) François Curtin et al.   mAbs

Assessment of chemical modifications of sites in the CDRs of recombinant antibodies

(2014) Markus Haberger et al.   mAbs

Clinical development success rates for investigational drugs

(2014) Michael Hay et al.   NATURE BIOTECHNOLOGY

Aggregation of Human Recombinant Monoclonal Antibodies Influences the Capacity of Dendritic Cells to Stimulate Adaptive T-Cell Responses In Vitro

(2014) Verena Rombach-Riegraf et al.   PLoS One

Albumin as a versatile platform for drug half-life extension

(2013) Darrell Sleep et al.   BIOCHIMICA ET BIOPHYSICA ACTA-GENERAL SUBJECTS

Predicting the expression of recombinant monoclonal antibodies in Chinese hamster ovary cells based on sequence features of the CDR3 domain

(2013) Leon P. Pybus et al.   BIOTECHNOLOGY PROGRESS

T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation

(2013) Vibha Jawa et al.   CLINICAL IMMUNOLOGY

Viscosity of high concentration protein formulations of monoclonal antibodies of the IgG1 and IgG4 subclass – Prediction of viscosity through protein–protein interaction measurements

(2013) Martin S. Neergaard et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Autoantibodies to Variable Heavy (VH) Chain Ig Sequences in Humans Impact the Safety and Clinical Pharmacology of a VH Domain Antibody Antagonist of TNF-α Receptor 1

(2013) M. C. Holland et al.   JOURNAL OF CLINICAL IMMUNOLOGY

Optimization of a human IgG B-cell ELISpot assay for the analysis of vaccine-induced B-cell responses

(2013) Maja Jahnmatz et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Engineering a therapeutic IgG molecule to address cysteinylation, aggregation and enhance thermal stability and expression

(2013) Andrew Buchanan et al.   mAbs

Developability studies before initiation of process development

(2013) Xiaoyu Yang et al.   mAbs

Phase II and Phase III attrition rates 2011–2012

(2013) John Arrowsmith et al.   NATURE REVIEWS DRUG DISCOVERY

Identification and Multidimensional Optimization of an Asymmetric Bispecific IgG Antibody Mimicking the Function of Factor VIII Cofactor Activity

(2013) Zenjiro Sampei et al.   PLoS One

High Molecular Weight Polyethylene Glycol Cellular Distribution and PEG-associated Cytoplasmic Vacuolation Is Molecular Weight Dependent and Does Not Require Conjugation to Proteins

(2013) Daniel G. Rudmann et al.   TOXICOLOGIC PATHOLOGY

Weak Interactions Govern the Viscosity of Concentrated Antibody Solutions: High-Throughput Analysis Using the Diffusion Interaction Parameter

(2012) Brian D. Connolly et al.   BIOPHYSICAL JOURNAL

Minimizing immunogenicity of biopharmaceuticals by controlling critical quality attributes of proteins

(2012) Miranda M. C. van Beers et al.   Biotechnology Journal

Native-State Solubility and Transfer Free Energy as Predictive Tools for Selecting Excipients to Include in Protein Formulation Development Studies

(2012) Douglas D. Banks et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights

(2012) Iain C. Macdougall et al.   KIDNEY INTERNATIONAL

Poster Sessions

(2012) Eugen Dhimolea et al.   mAbs

Viscosity measurements of antibody solutions by photon correlation spectroscopy: an indirect approach – limitations and applicability for high-concentration liquid protein solutions

(2012) Michael Wagner et al.   PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY

GLP2-2G-XTEN: A Pharmaceutical Protein with Improved Serum Half-Life and Efficacy in a Rat Crohn’s Disease Model

(2012) Susan E. Alters et al.   PLoS One

A simple whole blood bioassay detects cytokine responses to anti-CD28 SA and anti-CD52 antibodies

(2012) Lucy Bailey et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Clinical testing for neutralizing antibodies to interferon-β in multiple sclerosis

(2012) Paul I. Creeke et al.   Therapeutic Advances in Neurological Disorders

Taking immunogenicity assessment of therapeutic proteins to the next level

(2011) I.C. Büttel et al.   BIOLOGICALS

Aggregates in monoclonal antibody manufacturing processes

(2011) María Vázquez-Rey et al.   BIOTECHNOLOGY AND BIOENGINEERING

Predicting cytokine storms: it's about density

(2011) M. J. Frigault et al.   BLOOD

Comparison of novel methods for predicting the risk of pro-inflammatory clinical infusion reactions during monoclonal antibody therapy

(2011) Lucy Findlay et al.   JOURNAL OF IMMUNOLOGICAL METHODS

High Throughput Formulation Screening for Global Aggregation Behaviors of Three Monoclonal Antibodies

(2011) Yi Li et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Assessment of Net Charge and Protein–Protein Interactions of Different Monoclonal Antibodies

(2011) Christian Lehermayr et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Multidimensional methods for the formulation of biopharmaceuticals and vaccines

(2011) Nathaniel R. Maddux et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Developability Index: A Rapid In Silico Tool for the Screening of Antibody Aggregation Propensity

(2011) Timothy M. Lauer et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Cardiopulmonary Arrest After Severe Anaphylactic Reaction to Second Infusion of Infliximab in a Patient with Ankylosing Spondylitis

(2011) H. MIKI et al.   JOURNAL OF RHEUMATOLOGY

ELISA and Multiplex Technologies for Cytokine Measurement in Inflammation and Aging Research

(2011) S. X. Leng et al.   JOURNALS OF GERONTOLOGY SERIES A-BIOLOGICAL SCIENCES AND MEDICAL SCIENCES

Tungsten-Induced Denaturation and Aggregation of Epoetin Alfa During Primary Packaging as a Cause of Immunogenicity

(2011) Andreas Seidl et al.   PHARMACEUTICAL RESEARCH

Natalizumab (Tysabri)

(2010) D.T. Selewski et al.   AMERICAN JOURNAL OF NEURORADIOLOGY

PEGylation of therapeutic proteins

(2010) Simona Jevševar et al.   Biotechnology Journal

Primate testing of TGN1412: right target, wrong cell

(2010) M Pallardy et al.   BRITISH JOURNAL OF PHARMACOLOGY

Post-translational modifications of protein biopharmaceuticals

(2010) Gary Walsh   DRUG DISCOVERY TODAY

Adverse drug reactions to biologics

(2010) Kathrin Scherer et al.   JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT

3D structure-based protein retention prediction for ion-exchange chromatography

(2010) Florian Dismer et al.   JOURNAL OF CHROMATOGRAPHY A

An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics

(2010) Satish K. Singh et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Formulation Development of Therapeutic Monoclonal Antibodies Using High-Throughput Fluorescence and Static Light Scattering Techniques: Role of Conformational and Colloidal Stability

(2010) Deborah S. Goldberg et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

The safety and side effects of monoclonal antibodies

(2010) Trevor T. Hansel et al.   NATURE REVIEWS DRUG DISCOVERY

Potential Aggregation-Prone Regions in Complementarity-Determining Regions of Antibodies and Their Contribution Towards Antigen Recognition: A Computational Analysis

(2010) Xiaoling Wang et al.   PHARMACEUTICAL RESEARCH

Stability of Protein Pharmaceuticals: An Update

(2010) Mark Cornell Manning et al.   PHARMACEUTICAL RESEARCH

Structure-based engineering of a monoclonal antibody for improved solubility

(2010) S.-J. Wu et al.   PROTEIN ENGINEERING DESIGN & SELECTION

High-throughput dynamic light scattering method for measuring viscosity of concentrated protein solutions

(2009) Feng He et al.   ANALYTICAL BIOCHEMISTRY

Pharmacological significance of glycosylation in therapeutic proteins

(2009) Huijuan Li et al.   CURRENT OPINION IN BIOTECHNOLOGY

Formulation and manufacturability of biologics

(2009) Steven J Shire   CURRENT OPINION IN BIOTECHNOLOGY

Quality by design for biopharmaceuticals

(2009) Anurag S Rathore et al.   NATURE BIOTECHNOLOGY

Prediction of Aggregation-Prone Regions in Structured Proteins

(2008) Gian Gaetano Tartaglia et al.   JOURNAL OF MOLECULAR BIOLOGY

Principles, approaches, and challenges for predicting protein aggregation rates and shelf life

(2008) William F. Weiss et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose

(2008) Christine H. Chung et al.   NEW ENGLAND JOURNAL OF MEDICINE

High-Throughput Self-Interaction Chromatography: Applications in Protein Formulation Prediction

(2008) David H. Johnson et al.   PHARMACEUTICAL RESEARCH

Engineering of a femtomolar affinity binding protein to human serum albumin

(2008) A. Jonsson et al.   PROTEIN ENGINEERING DESIGN & SELECTION

Heterogeneity of Monoclonal Antibodies

(2007) Hongcheng Liu et al.   JOURNAL OF PHARMACEUTICAL SCIENCES