Building the House of Rapid Sterility – A Successful Platform Approach to introducing Rapid Methods

This webinar will focus on the implementation of rapid sterility using a strategic platform approach to reduce the post-approval change burden, introduce the use of rapid methods earlier in the pipeline, and reduce validation time. It will also cover overcoming business challenges with alternative methods, perceptions of risk, regulatory challenges, and finance. It will discuss examples of these challenges regarding several products. This technology has been used both in development and commercial spaces, as these areas are very different and require different approaches to implementation. Although this presentation will focus on ATP bioluminescence, this approach may be used for all new alternative or rapid methods.

Presented by Sophie Drinkwater, Senior Scientist in Microbiology at AstraZeneca

Sophie Drinkwater is a senior scientist in microbiology at AstraZeneca, working in the New Modalities and Parenteral Development group. Sophie has worked in pharmaceutical microbiology for 8 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 user groups. 

Jon Kallay, Senior Scientific Portfolio Specialist, Charles River Microbial Solutions

Jonathan (Jon) Kallay is a Senior Scientific Portfolio Specialist working remotely for the Microbial Solutions product lines.  He is a subject matter expert on microbiological investigations for manufacturing facilities that make regulated products. Jon provides practical laboratory experience to help clients identify the optimal path forward for their labs. Jon received his Bachelors in biochemistry from Denison University before earning a post-graduate diploma in pharmaceutical microbiology from the University of Manchester.

Sponsored by Charles River Laboratories

For 30 years, Charles River has been dedicated to the development of precise, robust micro QC solutions that help bring your products to market safely and efficiently. Our mission is to provide industry-leading scientific and technological advances that not only meet ever-changing regulatory guidelines but set a new standard in the way you perform testing. We’ve purposely built our portfolio to bring you progressive products and services that deliver accurate, relevant and measurable data to fuel confident decisions on product quality for release. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture and protects your reputation.