Assessing the Use of Solid-Phase Cytometry for Rapid Bioburden Testing

This presentation explores the use of solid phase cytometry for in process bioburden, short shelf-life product and water testing. Solid phase cytometry is being looked at as the new frontier for pharmaceutical microbiology especially for cell and gene therapy. The presentation looks at the practicality, use and limit of detection of these methods in a GMP QC environment and determines what further work might be required. It focuses mainly on low bioburden and in process testing for small molecules. Other new technologies are discussed such as solid phase real time imaging and real time imaging for pharmaceutical development. 

Presented by Sophie Drinkwater, Associate Director in Microbiology at AstraZeneca

Sophie Drinkwater is an associate director in microbiology at AstraZeneca, working in the Global Product Development group. Sophie has worked in pharmaceutical microbiology for 9 years in both GMP quality control laboratories and pharmaceutical development. In her current role, alongside developing control strategies and regulatory authoring, Sophie is focused on the feasibility testing and implementation of rapid technology in the microbiology space. Sophie is also an active member of several industry consortiums involved in developing new technology solutions as well as global pharmaceutical microbiological strategy.