Surface acoustic wave biosensor as a functional quality method in pharmaceutics

• SAW biosensors are used for functional quality characterization in pharmaceutics.
• An aQbD approach aims to produce high quality data and results.
• CMAs such as sensitivity, selectivity and variability are evaluated.
• We suggest qualification tests as well as SSTs (system suitability tests).
• We recommend inclusion of biosensors into pharmacopoeia and pharmaceutical guidelines.

With the recent successes of biopharmaceuticals, new bioanalytical tools are needed for the functional quality characterization of new biological entities and biosimilars towards marketing authorization approval and during the product life. Biosensors are emerging technologies in the pharmaceutical field in drug discovery, development and Quality Control (QC) stages; however, they are not yet included in any pharmacopoeia. Surface acoustic wave (SAW) biosensors allow the user to detect and quantify binding events, giving information not only on affinity (KD) and kinetics (kon and koff), but also on viscoelastic effects. We present here an analytical quality by design (aQbD) based approach using somatropin (rhGH, recombinant human growth hormone) and derivatives as model biotechnological drugs and an antibody interaction partner to evaluate the functional quality. Using techniques described in ICH Q2, Q5 and Q8–11, we evaluated the performance of this SAW biosensor technique from a pharmaceutical quality point of view. CMAs (Critical Method Attributes) such as sensitivity, selectivity and variability are evaluated as a function of different experimental variables using DoEs (design of experiments). We suggest qualification tests as well as SSTs (system suitability tests), as required by the pharmaceutical competent authorities and recommend the inclusion of biosensor techniques into the different pharmacopoeia and pharmaceutical guidelines.