Histology Sample Preparation | Fixing, Processing, Sectioning, Staining
Histology is the study of microscopic tissues and their structures. Histology is an important part of biology, medicine and other
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Biologics
21st Century Cures Act
The FDA is continually working to improve patient outcomes by including patients as well as their comfort and safety in
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Biological Purity | Potency Assays
Biological purity and potency assays are procedures used by laboratories studying medicine, pharmacology, or other biological process, to assess or
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Immunogenicity of Biologics
The US Food and Drug Administration defines biologics as “a wide range of products such as vaccines, blood and blood
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Regulation of Biological Products and Biopharmaceutical Products
Biological products comprise a wide array of products, all of which are regulated in the US by FDA’s CBER (Center
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Potency Testing of Biopharmaceuticals
Potency testing is a term used to describe the process of measuring biological activity in a product. Many methods exist
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Pharmaceutical Drug Development (Small Molecules / Large Molecules)
In the world of pharmacology and drug development, there are two ways to classify the molecules used, as small and
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Ligand Binding Assays (LBAs)
Ligand binding assays is an analytical procedure commonly used for large molecules, that relies on ligand molecules binding to macromolecule
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Biomarkers | Disease Detection
Biomarkers, also called biological markers, are measurable indicators of a biological condition. The exact definition is “a characteristic that is
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Residual DNA Testing | Host Cell DNA Analysis
Residual DNA testing, or host cell DNA analysis, is the examination of products for traces of DNA that have been
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