Biological purity and potency assays are procedures used by laboratories studying medicine, pharmacology, or other biological process, to assess or measure the presence of a substance, referred to as an […]
The US Food and Drug Administration defines biologics as “a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic […]
Biological products comprise a wide array of products, all of which are regulated in the US by FDA’s CBER (Center for Biologics Evaluation and Research) division and include regulation of […]
Potency testing is a term used to describe the process of measuring biological activity in a product. Many methods exist to determine the potency of a biopharmaceutical such as ligand […]
In the world of pharmacology and drug development, there are two ways to classify the molecules used, as small and large molecules. This differentiation refers to more than size, it […]
Ligand binding assays is an analytical procedure commonly used for large molecules, that relies on ligand molecules binding to macromolecule receptors. LBAs are used to quantify biomarkers and anti-drug antibodies. […]
Biomarkers, also called biological markers, are measurable indicators of a biological condition. The exact definition is “a characteristic that is objectively measured and evaluated as an indicator of normal biological […]
Residual DNA testing, or host cell DNA analysis, is the examination of products for traces of DNA that have been unintentionally left on a product during manufacturing of biological products […]
Are you curious how vaccines are made? Or about the research and time that goes into their development? The U.S. Food and Drug Administration’s Center for Biologics Evaluations and Research, […]
Biosimilars are a class of pharmaceutical drug products that are similar to a currently licensed FDA biological product. Biosimilars can be more advantageous to both producers and consumers alike because […]
