The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability
نویسندگان
چکیده
منابع مشابه
The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability
The NISTmAb Reference Material (RM) 8671 is intended to be an industry standard monoclonal antibody for pre-competitive harmonization of best practices and designing next generation characterization technologies for identity, quality, and stability testing. It must therefore embody the quality and characteristics of a typical biopharmaceutical product and be available long-term in a stable form...
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Comprehensive analysis of monoclonal antibody therapeutics involves an ever expanding cadre of technologies. Lifecycle-appropriate application of current and emerging techniques requires rigorous testing followed by discussion between industry and regulators in a pre-competitive space, an effort that may be facilitated by a widely available test metric. Biopharmaceutical quality materials, howe...
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The feasibility of the production of a reference material for pesticide residue analysis in a cucumber matrix was investigated. Cucumber was spiked at 0.075 mg/kg with each of the 15 selected pesticides (acetamiprid, azoxystrobin, carbendazim, chlorpyrifos, cypermethrin, diazinon, (α + β)-endosulfan, fenitrothion, imazalil, imidacloprid, iprodione, malathion, methomyl, tebuconazole and thiabend...
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The development of Reference Materials for Nutrients in Seawater (RMNS) has been in progress since 1993. When RMNS were produced for nitrate, silicate, and phosphate, their initial homogeneities were as low as 0.1 to 0.2% in samples of high-nutrient seawater, such as deep water from the Pacific Ocean. The relative standard uncertainties associated with instability during long-term (4.8 years)...
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ژورنال
عنوان ژورنال: Analytical and Bioanalytical Chemistry
سال: 2018
ISSN: 1618-2642,1618-2650
DOI: 10.1007/s00216-017-0800-1