Category Archives: Analytics

Continuing a deeper dive into analytical development, let’s talk about residual impurity assays! It’s important to understand that during the production of biologics (proteins, nucleic acids, viruses) and small molecules it is inevitable that things will be introduced throughout that you want to remove through purification. For example, viruses are produced by cells in cultureContinue reading “Residual Impurity Assay”

Continuing a deeper dive into analytical development, we’ll start by talking about my favorite characterization assay (experiment/method/protocol) – the functional potency assessment! This particular characterization method is a way of quantifying how well the drug is able to execute the desired biochemical interactions within the cell in order to result in the expected therapeutic effect.Continue reading “Functional Potency Assay”

What is an analytical development scientist? (That’s me!) The development of a particular class or type of drug can span long periods of time and consist of collaborations amongst hundreds if not thousands of people. During this entire process it is critical to have lab-based assays (methods/protocols/tests) that can characterize the drug product in it’sContinue reading “Analytical Development”