Nick Brann Email & Phone Number

Raleigh-Durham-Chapel Hill Area

• Expanded role in the second Phase I project by coordinating and executing 50L Confirmation and 200L Demonstration runs to provide process scale-up data and non-GMP BDS for multiple pre-clinical studies.
• Authored process description document for future large-scale campaigns and process development report for the second Phase I project.
• Executed two viral clearance studies using both naïve and aged chromatography resin, and impurity clearance studies for a second Phase III project, followed by timely delivery of summary reports for each of the three.
• Utilized JMP 17 software for the analysis of DoE experiments to identify critical process parameters and set target ranges for critical quality attributes in each unit operation, leading to the completion of impact.
• Delivered a seminar to upwards of 100 KBI employees from several different departments on DSPD approach and results from the two Phase I development projects

Raleigh-Durham-Chapel Hill Area

• Implemented KBI's platform downstream purification process and coordinated with multiple departments as co-lead for two Phase I development projects
• Developed a strong capability for interfacing with clients, presenting data, and providing effective recommendations
• Significantly expanded knowledge and capabilities by using AKTA avant and UFDF systems to execute Scale Down Model Qualification (SDMQ) and Process Characterization (PC) studies for all unit operations within the Phase.
• Substantial experience in writing protocols and summary reports for SDMQ and PC studies
• Oversaw execution and participated in partial planning of multiple 200L Pilot-Scale supply runs to generate material for future bench-scale studies
• Attended viral clearance studies for both early and late phase projects in order to demonstrate log reduction of virus for specific processing steps

Raleigh-Durham-Chapel Hill Area

• Gained experience working with AKTA avant chromatography systems and multiple modes of UFDF (manual and automated systems) to assist in the basics of biologics process development for a Phase III project
• Also contributed to on-going data analysis as it related to process scale-up and platform process implementation

Bachelor Of Science - Bs, Biochemistry

Activities and Societies: Phi Delta Theta

Certificate, Biomanufacturing