21st Century Cures Act
The FDA is continually working to improve patient outcomes by including patients as well as their comfort and safety in
Read more
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
Read more
Immunogenicity of Biologics
The US Food and Drug Administration defines biologics as “a wide range of products such as vaccines, blood and blood
Read more
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
Read more
Potency Testing of Biopharmaceuticals
Potency testing is a term used to describe the process of measuring biological activity in a product. Many methods exist
Read more
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
Read more
Ligand Binding Assays (LBAs)
Ligand binding assays is an analytical procedure commonly used for large molecules, that relies on ligand molecules binding to macromolecule
Read more
Biomarkers | Disease Detection
Biomarkers, also called biological markers, are measurable indicators of a biological condition. The exact definition is “a characteristic that is
Read more
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
Read more
Vaccine Development
Are you curious how vaccines are made? Or about the research and time that goes into their development? The U.S.
Read more