“Validation of Analytical Procedures: Text and Methodology (ICH Q2(R1))” published by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human (ICH) is a tripartite harmonized guideline that identifies validation parameters needed for variety of laboratory methods to analyze drugs. The three parties involved in this harmonization are the US, EU and Japan. There are quite a lot of other ICH guidelines, which are categorized into 4 major groups:

In this article we will have a short look on the range of a method in context of analytical method validation.

The common guideline used for method validation, the ICH Q2(R1), defines range as an interval from the upper to the lower concentration of the analyte in the sample e.g. drugs for which the analytical method has been demonstrated to work with acceptable level of trueness, precision, and linearity. The linearity studies for a method usually define the range for it.

In this small blog article, we would like to explain the parameter “Linearity” for an analytical method validation, its importance, and how it is calculated.

Mathematically speaking, linearity is a function of values that can be graphically represented as a straight line. Similarly, as per the method validation ICH Q2(R2) guideline, the linearity of an analytical method can be explained as its capability to show “results that are directly proportional to the concentration of the analyte in the sample” [1].

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.