الفهرس يوجد فقط 14 صفحة متاحة للعرض العام
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المستخلص
Biopharmaceuticals are medical drugs produced using biotechnology; their use has greatly expanded when compared to small molecule drugs. Biopharmaceuticals are complex molecules, so regulatory agencies need full characterization, stability studies, identification of product related impurities and stability indicating assay methods in order to evaluate safety and efficacy of the products. In this study, an orthogonal testing protocol was developed and validated to assess the quality of recombinant human growth hormone. Reversed phase chromatography was used for determination of somatropin in presence of its chemical impurities such as deamidated and oxidized degradation products. The assay method was accurate and precise over a wide linear range. Aggregation of recombinant human growth hormone was assessed by three different methods including initial rapid screening of aggregates and their sizes by dynamic light scattering technique, which gives rapid indication about the presence of aggregates and their different sizes, followed by reducing and non-reducing SDS-PAGE to confirm primary structure, molecular weight and type of aggregates. Finally; determination of somatropin in presence of aggregates by SE-HPLC method was performed to confirm presence of aggregates and their relative amounts, the assay method was accurate and precise over wide linearity range. The primary structure of recombinant human growth hormone was confirmed also by peptide mapping using RP-HPLC method. Different spectroscopic techniques were used to determine the total protein content regardless of impurities, so the results should be correlated with the results in other sections which allow full characterization of recombinant human growth hormone