W. Alexander Mengel, AbbVie Deutschland GmbH & Co. KG, Analytical R&D, Germany
Cell based potency assays (bioassays) are a central element of the analytical control strategy of biologics since they are the only method capable of testing a drug´s effect in living cells. The requirements for bioassays in pharmaceutical development are high: On the one hand, the drug´s intended physiological Mode of Action (MoA) must be accurately captured. On the other hand, the assay must show a high degree of precision, accuracy and robustness to ensure reproducibility across laboratories around the world. Moreover, a certain degree of flexibility regarding assay performance must be maintained to facilitate routine sample measurement. Finding the right balance between these key requirements is the challenge for potency assay development.
This presentation will highlight achievements greatly facilitating potency assay development including usage of „assay ready cells“, reporter gene assays, application of quality by design tools to systematically identify critical assay parameters and lab automation. Together, these tools have revolutionized the development of potency assays and are indispensable for modern pharmaceutical development.
W. Alexander Mengel is an employee of AbbVie and may own AbbVie stock. AbbVie sponsored and funded the study; contributed to the design; participated in the collection, analysis, and interpretation of data, and in writing, reviewing, and approval of the final publication.
