Zobrazeno 1 - 10
of 10
pro vyhledávání: '"Faten A. Fathalla"'
Publikováno v:
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences. 1184
Biosimilar products present a growing opportunity to improve the global healthcare systems. The amount of accepted variability during the comparative assessments of biosimilar products introduces a significant challenge for both the biosimilar develo
Autor:
Medhat A. Al-Ghobashy, Samah S. Abbas, Basma M. Eltanany, Abeer A. Mohamed, Faten A. Fathalla, Sara M. Shatat
Publikováno v:
Journal of Chromatography B. 1072:105-115
Peptide mapping (PM) is a vital technique in biopharmaceutical industry. The fingerprint obtained helps to qualitatively confirm host stability as well as verify primary structure, purity and integrity of the target protein. Yet, in-solution digestio
Publikováno v:
Biologicals. 50:129-136
Recombinant human erythropoietin (rhEPO) is a commonly used biopharmaceutical for the treatment of anemia-associated disorders. Epogen; glycosylated erythropoietin (G-EPO) has short half-life and poor stability. Pegylated Epogen (Peg-G-EPO) was intro
Publikováno v:
Biologicals. 44:596-599
A sandwich-type ELISA was optimized and validated to determine the in-vitro relative potency of the four-component prophylactic Human papillomavirus (HPV) vaccine. The vaccine contains the non-infectious virus like particles (VLP) corresponding to HP
Publikováno v:
Journal of Chromatography B. 1032:211-217
Quadrivalent human papillomavirus (HPV) vaccine is formulated of four types of non-infectious recombinant virus like particles (VLPs) that are structurally and immunologically similar to the corresponding infectious HPV virus types 6, 11, 16 and 18.
Publikováno v:
Chromatographia. 78:1005-1015
In the biopharmaceutical industry, protein aggregation and/or degradation has profound pathological implications and is encountered routinely during production, shipping, storage and administration. Lenograstim (glycosylated recombinant human granulo
Publikováno v:
Journal of pharmaceutical and biomedical analysis. 150
Antibody-drug conjugates (ADC) represent an emerging, novel class of biopharmaceuticals. The heterogeneity originating from the sophisticated structure requires orthogonal analytical techniques for quality and stability assessment of ADC to ensure sa
Publikováno v:
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences. 1060
Aggregate formation is a major problem affecting both safety and efficacy of biopharmaceuticals and is associated with protein immunogenicity. Size exclusion high performance liquid chromatography (SE-HPLC) has always been the gold standard technique
Publikováno v:
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences. 1046
In this work pH-responsive neutral and cationic polyacrylamide molecularly imprinted polymers (nMIP and cMIP, respectively) were prepared for separation of recombinant and wild type human serum albumin (HSA, pI 4.7) using mixture of polymerization in
Publikováno v:
Journal of pharmaceutical and biomedical analysis. 97
An orthogonal testing protocol was developed and validated to assess the quality of Filgrastim biosimilars. Results were compared to those obtained from the innovator product. Initial screening was carried out using reducing and non-reducing gel elec