Absorption Systems, a world leader in novel test systems for drug transporters, has announced a technology licensing agreement with Pfizer. The core technology is a human cell line engineered to express an individual drug transport protein, designed to test for potential safety issues early in the drug development process.
The cell line is stably transfected with the human SLCO1B1 gene, which codes for a protein known as organic anion transporting polypeptide (OATP) 1B1. Drug transporters such as OATP1B1 have received attention from drug regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) because of their importance in drug absorption, efficacy, elimination, and safety.
Only in recent years have scientists come to appreciate the importance of transporters and their genetic variants in different individuals. Test systems such as the OATP1B1-transfected cells have led to a better understanding of the roles that drug transporters play in overall drug disposition, and make it possible to predict potentially dangerous drug-drug interactions long before a new drug is administered to people.
This human OATP1B1 assay system will enable Pfizer to test potential new drug candidates for interactions with OATP1B1, which plays a central role in the effectiveness, safety, and drug-drug interactions of many drugs, including the widely used statins. Drug candidates that are substrates or inhibitors of OATP1B1 may look promising in early-stage testing but have safety issues once they get into clinical trials or post-approval, which is why the FDA and EMA now require lab-based testing for such interactions. The Absorption Systems cell line expresses OATP1B1 at a high level and allows users to predict human outcomes during preclinical testing.
Absorption Systems is well known for its rigorous quality control programs and relentless tracking of cell line performance over time by using its proprietary CellPort Analytics software. This is why pharmaceutical companies rely on Absorption Systems for preclinical testing platforms and services.