Liaison(s): Craig Vincze
Alphinity is a bioproduction equipment start-up company headquartered in Carson City, Nevada, with a mission to increase drug production efficiency and accessibility to essential medicines throughout the world. Due to limitations of drug manufacturing technologies in the pharmaceutical industry that result in the lack of supply to meet demand, there are billions of patients that have no access to necessary medicines. Alphinity’s solution is a polymorphic pump technology that is expected to reduce production cost, increase product yield, and be applicable through the development of next generation single-use bioproduction equipment. This technology, referred to as the PIXER®, is a novel, single-use, blending pump that offers a scalable two-in-one solution for all types of drug production unit operations. At KGI, the Alphinity TMP team was tasked with investigating the mixing characteristics and utility of the PIXER® to be used for bioprocessing. Initially designed for downstream specific steps, the team conducted experiments and studies that characterized the PIXER® in the application of a single-use bioreactor. These experiments included cell viability studies, kLa experiments, mixing studies, and aseptic verification studies. The results from these tests were statistically compared to similar tests in industry standard single-use-benchtop bioreactors. This comparison enabled the team to make a conclusion on the PIXER® suitability for mixing media and cell growth. A research report and application notes on the PIXER® pump were developed based on the findings, which Alphinity can thereby use to inform future customers of the PIXER® capabilities.