There is an additional concept within BioPharmaSpec’s method design concept which relates to an understanding of the expected experimental error for the method being developed. Many of BioPharmaSpec’s current analytical programs are focused on the question of whether a new batch of a product is comparable to the previous or whether a biosimilar is comparable to an innovator reference product. To be able to conclude whether two or more products are comparable requires a knowledge of the expected experimental variance for each of the methods employed.
This is why every method that BioPharmaSpec provides is developed according to the concepts in the table above, as has always been the case. Methods can then be qualified according to ICH Q2(R1), with an eye on the new revision ICH Q2(R2), using standard peptides, proteins, glycoproteins or oligosaccharides as appropriate. Critical methods (i.e. those being used to make critical decisions about the product and those that are destined to potentially become release tests) are also qualified using the product itself with the reliability, robustness, specificity, repeatability, intermediate precision, linearity and accuracy of the method being assessed as appropriate for the methods use.
In summary, although AQbD is being discussed as a new concept that the analytical scientist should be strongly considering, in our eyes it is something that we have simply always done in order to provide the most reliable and robust methods for assessing structural and physicochemical properties of biological products.