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Increased Expression Level of Human Blood Clotting Factor VIII Using NS0 Cell Line as a Host Cells.
Iran J Biotechnol
April 2024
Immunology, Asthma and Allergy Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Background: Coagulation factor VIII (FVIII) is applied for spontaneous hemorrhaging inhibition and excessive bleeding after trauma in patients with hemophilia A. High-quality human recombinant factor VIII (rFVIII) has been produced relatively in large quantities in cultured mammalian cells. NS0 is one of the most common mammalian cell lines for therapeutic protein production.
View Article and Find Full Text PDFSite-Specific Glycosylation Analysis of Murine and Human Fcγ Receptors Reveals High Heterogeneity at Conserved -Glycosylation Site.
J Proteome Res
March 2024
Translational Glycobiology Institute, Department of Translational Medicine, Herbert Wertheim College of Medicine, Florida International University, Miami, Florida 33199, United States.
Fc γ-receptors (FcγRs) on leukocytes bind immunoglobulin G (IgG) immune complexes to mediate effector functions. Dysregulation of FcγR-mediated processes contributes to multiple inflammatory diseases, including rheumatoid arthritis, lupus, and immune thrombocytopenia. Critically, immunoregulatory -glycan modifications on both FcγRs and IgGs alter FcγR-IgG binding affinity.
View Article and Find Full Text PDFPharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI-751): Results From a Randomized Phase 1 Trial.
Clin Pharmacol Drug Dev
October 2023
BioFactura, Inc., MD, USA.
BioFactura has developed a proposed biosimilar candidate (BFI-751) to ustekinumab reference product. Results are reported for the first-in-human trial designed to compare the pharmacokinetic profiles, safety, and immunogenicity of BFI-751 and ustekinumab reference products from the European Union and United States as well as similarity of the EU and US reference products. This was a multicenter, randomized, double blind, 3-parallel-group study (trial ID: NCT04843631).
View Article and Find Full Text PDFDetermination of size variants by CE-SDS for approved therapeutic antibodies: Key implications of subclasses and light chain specificities.
J Pharm Biomed Anal
May 2020
Biologics CMC and Developability, IRPF - Centre d'Immunologie Pierre-Fabre (CIPF), Saint-Julien-en-Genevois, France. Electronic address:
In the present work, a generic non-reducing capillary electrophoresis sodium dodecyl sulphate (nrCE-SDS) method was tested for a wide range of 26 FDA and EMA approved monoclonal antibodies (mAbs) and 2 antibody drug conjugates (ADCs) as well as for the NISTmab, in a QC environment (e.g. testing quality requirements for batch manufacturing or batch release).
View Article and Find Full Text PDFLevosimendan prevents doxorubicin-induced cardiotoxicity in time- and dose-dependent manner: implications for inotropy.
Cardiovasc Res
March 2020
National and Kapodistrian University of Athens, Laboratory of Pharmacology, Faculty of Pharmacy, Panepistimiopolis, Zografou, Athens 15771, Greece.
Aims: Levosimendan (LEVO) a clinically-used inodilator, exerts multifaceted cardioprotective effects. Case-studies indicate protection against doxorubicin (DXR)-induced cardiotoxicity, but this effect remains obscure. We investigated the effect and mechanism of different regimens of levosimendan on sub-chronic and chronic doxorubicin cardiotoxicity.
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