Bioreactor Studies – Lab Based Experimental designs to characterize the PIXER including but not limited to: determination of gas mass flow rate (kLa), shear forces experienced by cells or AAV’s as measured by cell viability […]
Automation Discovery in Clinical Supply Chain The Global Study Planners (GSPs) ensure that clinical final drug product (FDP) supply is consistently available for 20,000+ patients across 200+ clinical studies globally. Although there are several digital tools […]
Single Use Bioreactor Environmental Impact Compare and contrast the environmental impact for routine use of the following four approaches to sterile bioprocess solution preparation [the scenarios]: Stainless steel tanks, Traditional single-use mixers, A new proprietary […]
Digital Integration and Visualization Amgens Digital Integration and Predictive Technologies organization is a global process development function that develops and deploys state of the art advanced computational technologies in: 1) data capture, integration and […]
FDA Filing Documentation Preparation Development of a briefing book for a Type C meeting with the FDA regarding a Phase 2 multicenter study for the use of Tomolarimab in the treatment of myelodysplastic syndrome.
Developing Standard Work and Risk Assessment to Improve Critical Operations This project is focused on developing Standard Work to improve critical operations at the Abzena San Diego cGMP Facility. The TMP team will be responsible for identifying and collaborating with […]
Gut Microbiome Studies Gut microbiome dysbiosis has become a major threat to public health in current times world-wide but particularly in urban areas where food has become metabolically narrow thus destroying the diversity […]
Plant Capacity Modeling This year’s BI TMP will focus on building the groundwork for a new plant model capable of simulating the Upstream and Downstream operations in the production facility at BI Fremont. […]
Downstream CFD Modeling The objective of this project is to enhance our understanding of mixing in downstream hold tanks and associated small-scale models through computational fluid dynamics (CFD). These portable and fixed hold […]
Manufacturing Cost Standards BSi uses process and financial standards with a variety of real-world applications, including program investment analysis and potential deal valuations. Were interested in engaging a team of graduate students to […]