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Interrogation of Structure–Activity Relationships in Charge Variants of Therapeutic IgG2s Enabled by Free-Flow Isoelectric Focusing Fractionation
Interrogation of Structure–Activity Relationships in Charge Variants of Therapeutic IgG2s Enabled by Free-Flow Isoelectric Focusing Fractionation
Recombinant immunoglobulin G2 (IgG2) antibodies are effective neutralization agents or antagonists with high medical value...
Progress and Challenges in the Treatment of Fabry Disease
Progress and Challenges in the Treatment of Fabry Disease
Fabry disease is a rare but life-threatening, X-linked, inherited lysosomal storage disorder in which globotriaosylceramid...
Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase
Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase
Promoting the use of biosimilars is a global issue from the perspective of reducing medical costs. In Japan, the replaceme...
Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?
Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?
To evaluate the impact of demand- and supply-side policies on the biosimilar market penetration and identify effective str...
Emerging Therapy in Osteoarthritis: Mesenchymal Stem Cells, Secretomes, and Using Hydrogels to Enhance Efficacy
Emerging Therapy in Osteoarthritis: Mesenchymal Stem Cells, Secretomes, and Using Hydrogels to Enhance Efficacy
Osteoarthritis is a prevalent condition among middle-aged and elderly populations characterized primarily by the progressi...
Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings
Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings
The introduction of biosimilars into healthcare systems globally is recognized by many as a healthcare success. Despite th...
The Use of Biologics for Thyroid Eye Disease
The Use of Biologics for Thyroid Eye Disease
Thyroid eye disease (TED) is the most common extrathyroidal manifestation of Graves’ disease. It is an autoimmune di...
Emerging Role of Targeted Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders
Emerging Role of Targeted Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders
Neuromyelitis optica spectrum disorder (NMOSD) is a rare, autoimmune disease that results in recurring, often severe attac...
Influence of Pharmacokinetic-Pharmacodynamic Failure Mechanisms on Outcomes in Biologic Therapy Sequencing in Inflammatory Bowel Disease: A Retrospective Cohort Study
Influence of Pharmacokinetic-Pharmacodynamic Failure Mechanisms on Outcomes in Biologic Therapy Sequencing in Inflammatory Bowel Disease: A Retrospective Cohort Study
Increasing therapeutic options for inflammatory bowel disease calls for tools to aid choice of sequencing. We investigated...
Lipid-Lowering RNA Therapeutics for Atherosclerotic Cardiovascular Disease Prevention: A State−of−the−Art Review
Lipid-Lowering RNA Therapeutics for Atherosclerotic Cardiovascular Disease Prevention: A State−of−the−Art Review
Despite the modern era of effective and safe high-intensity statins and non-statin agents, a significant portion of patien...
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study
Comparative immunogenicity is a key regulatory requirement for biosimilars. In a streamlined biosimilar development proces...
Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline
Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline
Since blinatumomab’s approval as the first bispecific antibody (BsAb) in cancer therapy, these immunomodulatory agen...
Individual Prescribing Incentives for Biosimilars in Selected European Countries and the USA: a Scoping Literature Review
Individual Prescribing Incentives for Biosimilars in Selected European Countries and the USA: a Scoping Literature Review
The uptake of biosimilar medicines in Europe and the USA remains highly variable and at times slow, despite the significan...
Comprehensive Physico-Chemical and Functional Similarity Assessment of Intravenous and Subcutaneous RGB-19 Drug Products as Proposed Biosimilars to Tocilizumab Reference Product
Comprehensive Physico-Chemical and Functional Similarity Assessment of Intravenous and Subcutaneous RGB-19 Drug Products as Proposed Biosimilars to Tocilizumab Reference Product
Tocilizumab is a recombinant, humanised monoclonal antibody of the immunoglobulin G1 (IgG1) subclass, which specifically t...
Comprehensive Physico-chemical and Functional Similarity Assessment Study of RGB-14-P and RGB-14-X Drug Products as Proposed Biosimilars to Denosumab Reference Products
Comprehensive Physico-chemical and Functional Similarity Assessment Study of RGB-14-P and RGB-14-X Drug Products as Proposed Biosimilars to Denosumab Reference Products
Denosumab is a fully human monoclonal antibody (IgG2) k subclass that targets and binds with high affinity and specificity...
Introduction of Biopharmaceuticals in Europe: A Cross-Sectional Study of Early Diffusion Patterns and Data Availability
Introduction of Biopharmaceuticals in Europe: A Cross-Sectional Study of Early Diffusion Patterns and Data Availability
Biopharmaceuticals add value in the treatment of many diseases but different health systems in Europe face clinical and ec...
Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024
Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024
Advanced therapy medicinal products (ATMPs) often require long-term monitoring to assess both safety and efficacy post-aut...
Targeting CD20 for B-cell Depletion in Autoimmune Kidney Disease: Next Generation
Targeting CD20 for B-cell Depletion in Autoimmune Kidney Disease: Next Generation
Anti-CD20 monoclonal antibodies are gaining clinical relevance in the nephrology community due to their demonstrated effic...
The role of skin testing, drug challenge and IFN-γ ELISpot in delayed hypersensitivity to iodinated contrast media
The role of skin testing, drug challenge and IFN-γ ELISpot in delayed hypersensitivity to iodinated contrast media
The use of in vivo and ex vivo diagnostic tools for delayed hypersensitivity reactions (DHRs) associated with iodinated co...
Characterizing the symptomatology and pathophysiology of allergic rhinitis using a nasal allergen challenge model – a subset of the allergic rhinitis microbiome study
Characterizing the symptomatology and pathophysiology of allergic rhinitis using a nasal allergen challenge model – a subset of the allergic rhinitis microbiome study
Since 2015, our nasal allergen challenge (NAC) protocol has been used to investigate the pathophysiology of allergic rhini...
NOURISH-US: a mixed-methods, randomized crossover study of a program designed to reduce the financial burden of food allergy
NOURISH-US: a mixed-methods, randomized crossover study of a program designed to reduce the financial burden of food allergy
Food allergy imposes considerable financial costs on families, but few programs are available in Canada to offset these co...
Clinicopathological and Immunogenetic Characterization in 8 Patients with Familial Hemophagocytic Lymphohistiocytosis Type 2: A Study from North India with Literature Review
Clinicopathological and Immunogenetic Characterization in 8 Patients with Familial Hemophagocytic Lymphohistiocytosis Type 2: A Study from North India with Literature Review
Familial hemophagocytic lymphohistiocytosis type 2 (FHL2) is the commonest cause of familial hemophagocytic lymphohistiocy...
BK Virus-Specific T Cell Response Associated with HLA Genotypes, RhD Status, and CMV or EBV Serostatus in Healthy Donors for Optimized Cell Therapy
BK Virus-Specific T Cell Response Associated with HLA Genotypes, RhD Status, and CMV or EBV Serostatus in Healthy Donors for Optimized Cell Therapy
The increasing application of virus-specific T cell therapy for treating BK virus infections in immunocompromised patients...
Somatic Mosaic Variants in Autoinflammatory Diseases: Functional Characterization and Correlation of Mosaicism Levels with Disease Age of Onset and Severity
Somatic Mosaic Variants in Autoinflammatory Diseases: Functional Characterization and Correlation of Mosaicism Levels with Disease Age of Onset and Severity
Autoinflammatory diseases (AIDs) are a group of disorders caused by a dysregulation of the innate immune system, among whi...
Evaluation of a Multiplex Electrochemiluminescence Assay for Detection of Anti-Pneumococcal Antibodies in the Diagnosis of Selective Polysaccharide Antibody Deficiency
Evaluation of a Multiplex Electrochemiluminescence Assay for Detection of Anti-Pneumococcal Antibodies in the Diagnosis of Selective Polysaccharide Antibody Deficiency
Streptococcus pneumoniae can be responsible for severe infections, especially in patients with primary antibody deficienci...
Reassessing Polysaccharide Responsiveness: Unveiling Limitations of Current Guidelines and Introducing the Polysaccharide Responsiveness Percentile Approach
Reassessing Polysaccharide Responsiveness: Unveiling Limitations of Current Guidelines and Introducing the Polysaccharide Responsiveness Percentile Approach
The assessment of polysaccharide responsiveness via vaccination is pivotal in the evaluation of patients for primary immun...
Discordant Restoration of TCR Expression and Function by CD247 Somatic Reversions
Discordant Restoration of TCR Expression and Function by CD247 Somatic Reversions
The CD247 chain of the T-cell receptor (TCR) is essential for normal T cell development and function. Reported CD247-defic...
Pilot Study of Anti-PD-1 Antibody Combined with L-DEP Regimens in the Treatment of Relapsed/Refractory EBV-HLH in Children
Pilot Study of Anti-PD-1 Antibody Combined with L-DEP Regimens in the Treatment of Relapsed/Refractory EBV-HLH in Children
Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis (EBV-HLH) is a commo...
Molecular Interactions Between NK Cells and Acute Leukemic Cells: KIR2DL5 Drastically Limits NK Cell Responses
Molecular Interactions Between NK Cells and Acute Leukemic Cells: KIR2DL5 Drastically Limits NK Cell Responses
Natural Killer (NK) cells naturally recognize and eliminate leukemic cells. However, the molecular interactions that gover...
Loss of MALT1 Function in a Patient With Combined Immunodeficiency: a Novel Pathogenic Variant and Immunological Insights
Loss of MALT1 Function in a Patient With Combined Immunodeficiency: a Novel Pathogenic Variant and Immunological Insights
Germline pathogenic variants in the mucosa-associated lymphoid tissue lymphoma translocation gene 1 (MALT1) encodes a casp...
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