As announced in summer this year and now in more detail in November, ICH's guideline on validating analytical methods will be revised. The content of this guideline comes from two previously separate guidelines merged in 2005, which were published more than 20 years ago. The decision to revise the validation guideline ICH Q2(R1) was made at the ICH meeting in June, together with the decision to create a new analytical procedure development guideline (ICH Q14). Currently, it is unknown whether these will be two separate documents, or whether a combined guideline will result as a possible combination should be examined by the Expert Working Group.

In our last blog post we had a look on the first approach to infer trueness from linearity in method validations by applying normalization. This can be used to determine trueness in case no alternative methods or impurities for spiking are available. Apart from normalization, another possibility to solve this problem exists, which will be highlighted today.

In today's blog, we’d like to address a quite common problem during method validations and by using a practical example showing possibilities to solve it.

Introduction and background

Monoclonal antibodies (mABs) are immunoglobulin molecules that bind to the same epitope and have a variety of applications in medicine and healthcare (e.g. as drugs). Although therapeutic mABs are extremely favorable due to their specificity, they are heterogeneous due to their manufacturing process and hence provide a challenge for characterization.