Quality Control of recombinant proteins: the case of infliximab

Recombinant proteins are complex molecules expressed by living organisms that present numerous possible conformations, post-translational modifications and microheterogeneity that should be pointed out in order to assure the quality, efficacy and safety of the final product. The Quality Target Product Profile (QTPP) is a concept described in the International Council for Harmonisation (ICH) Guideline Q8(R2) and includes all the Critical Quality Attributes of the product. One or more Analytical Procedures can be established to address a particular (or various) product’s Quality Attribute(s), being the analytical performance requirements based on the QTTP. In order to set up a horizontal analytical platform for monoclonal antibodies by Analytical Quality by Design (AQbD), infliximab was used as case study. Systematic method development based on AQbD is performed in different steps: the first step is the development of the Analytical Target Profile, which defines the purpose of the analytical method and the application scope; the second step is Quality Risk Assessment, in which all potential influencing factors are grouped by category in order to facilitate the examination of their influence on the method performances. In this presentation, a preliminary overview of the characterization of the monoclonal antibody infliximab by AQbD approach will be shown.