Fit-for-purpose validation of a drug-tolerant immunogenicity assay for a human mAb drug in animal safety studies

Prophylactic use of an anti-activated factor XII monoclonal antibody, garadacimab, for patients with C1-esterase inhibitor-deficient hereditary angioedema: a randomised, double-blind, placebo-controlled, phase 2 trial

(2022) Timothy Craig et al.   LANCET

FDA approves 100th monoclonal antibody product

(2021) Asher Mullard   NATURE REVIEWS DRUG DISCOVERY

A strategic approach to nonclinical immunogenicity assessment: a recommendation from the European Bioanalysis Forum

(2021) Anna Laurén et al.   Bioanalysis

A phase I, first‐in‐human, randomized dose‐escalation study of anti‐activated factor XII monoclonal antibody garadacimab

(2021) Andrew McKenzie et al.   CTS-Clinical and Translational Science

Pharmacokinetic/pharmacodynamic modeling for dose selection for the first‐in‐human trial of the activated Factor XII inhibitor garadacimab (CSL312)

(2021) Dipti Pawaskar et al.   CTS-Clinical and Translational Science

Antibody-mediated inhibition of FXIIa blocks downstream bradykinin generation

(2018) Helen Cao et al.   JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Bead-extraction and heat-dissociation (BEHD): A novel way to overcome drug and matrix interference in immunogenicity testing

(2018) Weifeng Xu et al.   JOURNAL OF IMMUNOLOGICAL METHODS

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

Factor XII-Driven Inflammatory Reactions with Implications for Anaphylaxis

(2017) Lysann Bender et al.   Frontiers in Immunology

Factor XII as a Therapeutic Target in Thromboembolic and Inflammatory DiseasesHighlights

(2016) Katrin F. Nickel et al.   ARTERIOSCLEROSIS THROMBOSIS AND VASCULAR BIOLOGY

Affinity capture elution bridging assay: A novel immunoassay format for detection of anti-therapeutic protein antibodies

(2016) Yan Q. Chen et al.   JOURNAL OF IMMUNOLOGICAL METHODS

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

Development and characterization of a pre-treatment procedure to eliminate human monoclonal antibody therapeutic drug and matrix interference in cell-based functional neutralizing antibody assays

(2015) Weifeng Xu et al.   JOURNAL OF IMMUNOLOGICAL METHODS

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

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

Comprehensive study into the activation of the plasma enzyme systems during attacks of hereditary angioedema due to C1-inhibitor deficiency

(2015) Dorottya Csuka et al.   Orphanet Journal of Rare Diseases

Assays and Strategies for Immunogenicity Assessment of Biological Agents

(2014) Francesca Nencini et al.   DRUG DEVELOPMENT RESEARCH

A Factor XIIa Inhibitory Antibody Provides Thromboprotection in Extracorporeal Circulation Without Increasing Bleeding Risk

(2014) M. Larsson et al.   Science Translational Medicine

Plasma kallikrein: the bradykinin-producing enzyme

(2013) Jenny Björkqvist et al.   THROMBOSIS AND HAEMOSTASIS

In vivo roles of factor XII

(2012) T. Renne et al.   BLOOD

Regulatory Forum Opinion Piece*

(2012) Michael W. Leach   TOXICOLOGIC PATHOLOGY

C1 inhibitor, a multi-functional serine protease inhibitor

(2010) Fengxin Lu et al.   THROMBOSIS AND HAEMOSTASIS

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