Nothing Special   »   [go: up one dir, main page]

Magnenat et al., 2017 - Google Patents

Demonstration of physicochemical and functional similarity between the proposed biosimilar adalimumab MSB11022 and Humira®

Magnenat et al., 2017

View PDF @Full View
Document ID
1778150677406670191
Author
Magnenat L
Palmese A
Fremaux C
D'Amici F
Terlizzese M
Rossi M
Chevalet L
Publication year
Publication venue
MAbs

External Links

Snippet

Biosimilars are biological products that are highly similar to existing products approved by health authorities. Demonstration of similarity starts with the comprehensive analysis of the reference product and its proposed biosimilar at the physicochemical and functional levels …
Continue reading at www.tandfonline.com (PDF) (other versions)

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by the preceding groups
    • G01N33/48Investigating or analysing materials by specific methods not covered by the preceding groups biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by the preceding groups
    • G01N33/48Investigating or analysing materials by specific methods not covered by the preceding groups biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • G01N33/746Erythropoetin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electro-chemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electro-chemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen

Similar Documents

Publication Publication Date Title
Magnenat et al. Demonstration of physicochemical and functional similarity between the proposed biosimilar adalimumab MSB11022 and Humira®
Seo et al. Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab
Piche-Nicholas et al. Changes in complementarity-determining regions significantly alter IgG binding to the neonatal Fc receptor (FcRn) and pharmacokinetics
Cho et al. Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept
Stracke et al. A novel approach to investigate the effect of methionine oxidation on pharmacokinetic properties of therapeutic antibodies
Huang et al. In vivo deamidation characterization of monoclonal antibody by LC/MS/MS
Schlothauer et al. Analytical FcRn affinity chromatography for functional characterization of monoclonal antibodies
Khawli et al. Charge variants in IgG1: isolation, characterization, in vitro binding properties and pharmacokinetics in rats
Nupur et al. Assessment of structural and functional similarity of biosimilar products: rituximab as a case study
Hong et al. Physicochemical and biological characterization of SB2, a biosimilar of Remicade®(infliximab)
Yeung et al. Engineering human IgG1 affinity to human neonatal Fc receptor: impact of affinity improvement on pharmacokinetics in primates
Suzuki et al. Importance of neonatal FcR in regulating the serum half-life of therapeutic proteins containing the Fc domain of human IgG1: a comparative study of the affinity of monoclonal antibodies and Fc-fusion proteins to human neonatal FcR
Bandyopadhyay et al. Physicochemical and functional characterization of a biosimilar adalimumab ZRC-3197
Tan et al. Characterization and comparison of commercially available TNF receptor 2-Fc fusion protein products
Wang et al. Impact of methionine oxidation in human IgG1 Fc on serum half-life of monoclonal antibodies
Majumdar et al. Correlations between changes in conformational dynamics and physical stability in a mutant IgG1 mAb engineered for extended serum half-life
Peters et al. Engineering an improved IgG4 molecule with reduced disulfide bond heterogeneity and increased Fab domain thermal stability
van Schie et al. Therapeutic TNF inhibitors can differentially stabilize trimeric TNF by inhibiting monomer exchange
Ishino et al. Engineering a monomeric Fc domain modality by N-glycosylation for the half-life extension of biotherapeutics
Shire Monoclonal antibodies: meeting the challenges in manufacturing, formulation, delivery and stability of final drug product
Gong et al. Shortened engineered human antibody CH2 domains: increased stability and binding to the human neonatal Fc receptor
Datta-Mannan et al. Aberrant bispecific antibody pharmacokinetics linked to liver sinusoidal endothelium clearance mechanism in cynomolgus monkeys
Xu et al. Physicochemical and functional assessments demonstrating analytical similarity between rituximab biosimilar HLX01 and the MabThera®
Kelly et al. Target-independent variable region mediated effects on antibody clearance can be FcRn independent
Wang et al. Impact of SPR biosensor assay configuration on antibody: Neonatal Fc receptor binding data