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This document is an application form for the assignment of United States Adopted Names (USAN) to specific biologics, including monoclonal antibodies, gene therapies, and other cellular and non-cellular therapies.
Note: Year
Region / City: United States
Topic: Pharmaceutical naming and regulatory processes
Document type: Application form
Organization / Institution: United States Adopted Names Council, American Medical Association
Target audience: Pharmaceutical companies, researchers, regulatory authorities
Price: 8 / 10 USD
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Direct Referral Template for Community Access to Neutralising Monoclonal Antibodies (nMAB) and Oral Antivirals for Covid-19 Treatment
Note: Date
Heavy and Light Chain Sequences for 5F9, the Human IgG1 Monoclonal Antibody Targeting the Extracellular Domain of GCC
Year: 2023
Region / City: Not specified
Topic: Monoclonal antibody sequences, growth rate inhibition in cell models
Document type: Research Supplementary Material
Organization / Institution: Not specified
Author: Not specified
Target audience: Researchers, biomedical professionals
Effective period: Not specified
Approval date: Not specified
Modification date: Not specified
COVID-19 Monoclonal Antibody (mAb) EUA Treatment Referral Form for Regional Sites
Year: 2026
Region / City: Canada, multiple cities
Subject: COVID-19 treatment eligibility
Document Type: Medical referral form
Organization / Institution: Health Canada; regional hospitals
Author: Clinicians completing referral
Target Audience: Healthcare providers and eligible patients
Eligibility Criteria: Adults and pediatric patients ≥12 years, ≥40 kg, at high risk of severe COVID-19
Treatment Window: Within 7 days of symptom onset
Authorization: Interim authorization (Interim Order) by Health Canada
Patient Data Fields: Name, Date of birth, Allergies, Address, Contact information, Health Card Number
Clinical Criteria: Symptomatic status, vaccination status, comorbidities, immunosuppression, prior COVID-19 infection
Referral Confirmation: Clinician attestation with signature, date, and College number
Supplemental Methods: Monoclonal Antibodies, Cell Lines, Retroviral Vectors, and B7-H3 CAR-T Cell Generation
Section: Supplemental Methods
Field: Immunology and Hematologic Malignancies
Experimental focus: B7-H3 CAR-T cells in acute myeloid leukemia (AML)
Monoclonal antibodies: Anti-human CD markers and related reagents for flow cytometry
Suppliers: Becton-Dickinson (BD) Biosciences; Miltenyi Biotec; BioLegend; Jackson ImmunoResearch Labs
Cell lines: THP1; U937; HL-60; Kasumi-1; OCI-AML2; OCI-AML3
Primary samples: DFAM-6855; CBAM-44728 from Public Repository of Xenografts (PRoXe), Dana-Farber Cancer Institute
Biological material: Primary AML blasts; donor PBMCs; buffy coats from healthy volunteers
Vector system: SFG retroviral vector with MoMLV gag-pol and RD114 envelope
Transduction method: Retronectin-coated plates with retroviral supernatant
Cell expansion cytokines: IL7; IL15
Statistical methods: Mann Whitney test; one-way ANOVA with Holm-Sidak adjustment; Chi-square test
Software: Prism version 8 (GraphPad)
Sample origin: Bone marrow and peripheral blood from AML patients
Animal model: NSG mice for in vivo expansion of xenografts
Culture conditions: RPMI-1640 medium with fetal bovine serum, L-glutamine, penicillin, and streptomycin
KTN0158, a humanized anti-KIT monoclonal antibody, biological activity in normal and malignant human mast cells
Year: 2026
Location: United States
Subject: Immunology, Monoclonal Antibodies, Mast Cell Biology
Document Type: Research Supplement / Methods Section
Institution: Kolltan Pharmaceuticals
Authors: London et al.
Target Audience: Scientific researchers in immunology and pharmacology
Experimental Period: 2026
Cell Types: Human CD34+ progenitor cells, PBMCs, mast cells
Key Techniques: Flow cytometry, antibody assays, cell differentiation, KIT phosphorylation
Reagents: KTN0158, KTN0062C, KTN0209, KTN0235, Imatinib, Nilotinib, IL-3, IL-6, SCF, LDL
Supplementary Data on Clinical Trials of Monoclonal Antibody Therapy for Allergic Diseases
Year: 2023
Region / City: Beijing, China
Subject: Allergic diseases, monoclonal antibody therapy, clinical trials
Document Type: Supplementary data
Institution: Capital Medical University, Department of Immunology
Authors: Yan Chen, Wei Wang, Huihui Yuan, Yan Li, Zhe Lv, Ye Cui, Jie Liu, Sun Ying
Target Population: Children, adolescents, and adults with allergic asthma
Trial Duration: 12–60 weeks
Primary Outcomes: Treatment safety, efficacy, quality of life, pulmonary function, IgE levels
Sample Size Range: 19–4308 participants
Medications Studied: Omalizumab
Study Design: Controlled clinical trials with specific inclusion criteria for allergic asthma patients
Generation of rabbit monoclonal antibody against unprocessed human EF1a and EF1a-1 knockdown analysis in A549 and HCT116 cells
Year: 2026
Research area: Molecular biology / Cancer research
Document type: Supplementary figure
Institution: Unspecified research laboratory
Experimental models: A549 and HCT116 cancer cell lines
Methods: Monoclonal antibody production, siRNA knockdown, Simple Western analysis
Compounds tested: DMSO, M8891
Duration of treatment: 24 hours
Observation period: 96 hours post-knockdown
Controls: Non-targeting siRNA, γ-tubulin loading control
Visualization software: Protein Simple Compass
Evaluating the use of a weight-of-evidence approach to assess the need for chronic toxicity studies for therapeutic monoclonal antibodies
Year: 2024
Region / City: Europe
Topic: Preclinical drug safety assessment
Institution: Master’s programme, Drug Innovation
Author: Benedetta Boscolo Todaro
Supervisors: Hsiao-Tzu Chien, Marieke de Bruin, Peter Van Meer
Target audience: Regulatory scientists, pharmacologists
Study period: October 2024 – April 2025
Data analyzed: 42 monoclonal antibodies submitted for EMA approval (2017–2024)
Methodology: Weight-of-evidence approach, literature review, short-term toxicity studies
Ethical considerations: Reduction of animal testing, alignment with 3Rs principles
Topics: FUSAN Non-Cellular Monoclonal