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 the development of new drugs, biologics, and medical devices. A […]

Biologics

Biological Purity | Potency Assays

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 […]

Biologics

Immunogenicity of Biologics

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 […]

Biologics

Potency Testing of Biopharmaceuticals

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 […]

Biologics

Ligand Binding Assays (LBAs)

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. […]

Biologics

Biomarkers | Disease Detection

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 […]

Biologics

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 unintentionally left on a product during manufacturing of biological products […]

Biologics

Vaccine Development

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, […]