Blog articles

Journal Club: Validation of a cIEF method for antibody identification

Written by Anindya Ghosh Roy Posted in Method validation

Introduction and background

Monoclonal antibodies (mABs) are monovalent immunoglobulin molecules that bind only to the same epitope. These antibodies have a wide range of applications such as in diagnostics, analytics, and as drugs in the treatment of cancer and other autoimmune diseases. The emerging market of mAB biosimilars demands proper characterization after previously performed isolation of these molecules. Isolating these antibodies however is quite a challenge and was first done by Georges Köhler and César Milstein, for which they were awarded the Nobel prize in medicine and physiology in the year 1984.

What is the difference between specificity and selectivity?

Written by Anindya Ghosh Roy Posted in Method validation

In this small blog article, we would like to explain two terms often mixed up during analytical method validation. It’s about specificity and selectivity.

 

Specificity

According to the official guideline to be applied for method validation ICH Q2(R1), specificity is defined as:

“Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present.”

A day at the Analytica

Written by Anindya Ghosh Roy Posted in Think out of the box

I recently had a chance to visit the Analytica 2018, probably the largest International trade fair for innovative laboratory technology, analysis and Biotechnology, held in Munich, Germany. As a fresher to this field, I was about to witness the very best and my curiosity and enthusiasm went beyond words.

Journal Club: Validation of a clot lysis assay for potency

Written by Anindya Ghosh Roy Posted in Method validation

Introduction and background

Recombinant human tissue Plasminogen Activator (rt-PA), the synthetic version of Tissue plasminogen activator (tPA), is a serine protease involved in degradation of blood clots. As a drug it is used for the treatment of stroke. It functions by converting plasminogen into plasmin, which in turn degrades insoluble fibrin into soluble by-products. This process of converting fibrin into soluble by-products is called fibrinolysis.