Analytical Method Validation for Biopharmaceuticals
نویسندگان
چکیده
منابع مشابه
Assays for Controlling Host-Cell Impurities in Biopharmaceuticals
the manufacture of biopharmaceuticals is purification of the drug substance. The downstream process must remove all contaminants, including host cell material such as DNA and cellular protein. Trace amounts of host-cell DNA and proteins can be copurified along with the drug substance. Such contaminants are obviously undesirable because of possible consequences if they are injected into patients...
متن کاملCritical aspects regarding the application of GPL principles to new compounds such as biotechnology products.
The safety evaluation of new products such as the biotechnology-derived pharmaceuticals (biopharmaceuticals) requires a less standardised and more flexible approach. This is basically due to the characteristics of each product, especially so as regards species specificity and immunogenicity activity. Thus, it is necessary to select the relevant animal species for toxicity testing, to evaluate t...
متن کاملQuantitation of DNA and protein impurities in biopharmaceuticals.
The development of drugs and biologicals for human injection generated from recombinant DNA and hybridoma technologies has resulted in new standards for product purity. We discuss the regulatory position relative to impurities in these biopharmaceuticals, focusing on the analytical goals for quantitation. Current methods for making these measurements are reviewed, and a new system designed for ...
متن کاملDevelopment and Validation of a Terbium-Sensitized Luminescence Analytical Method for Deferiprone
A sensitive fluorometric method for the determination of deferiprone (DFP) based on the formation of a luminescent complex with Tb3+ ions in aqueous solutions is reported. The maximum excitation and emission wavelengths were 295 and 545 nm, respectively. The effects of various factors on the luminescence intensity of the system were investigated and optimized, then under the optimum conditions,...
متن کاملDevelopment and Validation of a Terbium-Sensitized Luminescence Analytical Method for Deferiprone
A sensitive fluorometric method for the determination of deferiprone (DFP) based on the formation of a luminescent complex with Tb3+ ions in aqueous solutions is reported. The maximum excitation and emission wavelengths were 295 and 545 nm, respectively. The effects of various factors on the luminescence intensity of the system were investigated and optimized, then under the optimum conditions,...
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