12th January 2022 | 10:00am EST / 3:00pm GMT / 4:00pm CET | Miriam Guest, New Modalities & Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK and Ulrich Herber Senior Director of Technology and Market Development at Charles River |WATCH FOR FREE
The adoption of rapid sterility testing has significant benefits to the pharmaceutical industry; providing early notification of control drifts, a non-subjective answer to the sterility test and a faster time to product release. However, the challenges of adoption can be daunting. By enhancing the benefits of regulatory interactions in the development phases, a complex post-approval regulatory change can be mitigated, however with limited material available, the outlined strategy provides a robust way forward to adopt rapid sterility and capture the benefits.
AstraZeneca considered the global operations of a major pharmaceutical company in the adoption of rapid sterility. Utilising risk assessment tools and a holistic overview of pharmaceutical cleanroom flora, a representative panel of global microorganisms was selected. Variability between product, consumables, organisms origin & status and testing sites was factored in.
Focused studies were performed and data will be shared to provide an outline of the operating range that has been verified for the ATP Bioluminescence based sterility test.
The presentation will outline a vast & powerful data set which supports the robustness of the rapid sterility test, to enhance our product understanding. Additional data was leveraged in time to result from studies for “challenging organisms” such as slow growers.
Presented by Miriam Guest, Associate Principal Microbiologist, New Modalities & Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK
Miriam Guest is an Associate Principal Microbiologist at AstraZeneca, working in the New Modalities and Parenteral Development group; based at their Macclesfield site in the UK. Miriam has worked in Pharmaceutical Development for over 20 years, in both microbiology & formulation laboratories and GMP manufacturing environments; more recently supporting complex supply chains and designing robust control strategies, including the associated regulatory authoring & interactions.
She leads the AZ Global Microbiology Forum, bringing together the global network of microbiology labs to drive standardisation and quality principals in Microbiology.
Miriam devised & leads AstraZeneca’s “21st Century Microbiology Strategy”, to innovate, industrialise and implement technology solutions to drive efficiencies and process robustness benefits within the AZ global network. Miriam has led many cross site improvement projects, one of which was awarded the AZ Global Operations Award for Performance in 2019.
She is an active committee member of the Pharmaceutical Microbiology Interest Group (Pharmig) and is involved in the Modernisation of Microbiology Cross Industry Consortium (MMCC).
Ulrich Herber Senior Director of Technology and Market Development at Charles River
After receiving his Doctorate Degree in organometallic chemistry from the University of Wuerzburg, Dr Ulrich Herber started his career in the pharmaceutical industry at Sartorius as a Product Manager for sterile filtration process validations. He then moved to Concept Heidelberg where he was the Operations Director for their business segment “Microbiological Quality Control and Biotechnology”. Later on, Dr Herber headed the European activities of Accugenix.
In his current role at Charles River, he is the Senior Director of Technology and Market Development for the Microbial Solutions division. Dr Herber is co-author of scientific papers on new methods applied in microbiological quality control. He has held several talks covering recent developments in the area of rapid microbiological methods and is an Advisory Board Member of the Pharmaceutical Microbiology Working Group at the European Compliance Academy.
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.