Current USP Perspectives on a Rapid Sterility Test
30th May 2018 | 10 AM UTC | Presented by Dr David Roesti, Novartis/USP and Erin Patton, Senior Product Specialist, Charles River |WATCH FOR FREE
The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under the USP General Chapters– Microbiology Expert Committee to provide recommendations on user requirements specifications and candidate technologies based on the URS in the area of rapid sterility tests. Based on the evaluation of the URS, the expert panel made recommendations for appropriate modern/rapid technologies available from multiple vendors. The next step would be to recruit collaborating labs to conduct the proof-of-concept studies that would support drafting of a rapid sterility test chapter in the USP.
Presented by Dr David Roesti, Novartis/USP
Dr. David Roesti holds a PhD in microbial ecology from the University of Neuchâtel, Switzerland and has 20 years of experience in the field of microbiology within various domains (drug product manufacturing, food microbiology, biogas production, microbial interactions in the rhizosphere).
Currently he works at Novartis Pharma AG in Stein Switzerland in the Manufacturing Science & Technology department and is responsible to define the microbial control strategy at the site and is a global subject matter expert in microbiology for the Novartis group. Prior to this assignment, he led the Rapid Microbiological Methods team at Novartis Pharma AG and was the laboratory supervisor for the microbiological testing of non-sterile drug products at Novartis Pharma Stein AG.
Dr. Roesti is an elected member of the General Chapters Microbiology Expert Committee of the Unites States Pharmacopoeia 2015-2020 revision cycle and is a member of the advisory board of the European Compliance Academy Microbiology Group.
Finally, Dr. Roesti is main author or co-author of many different publications in either peer-reviewed journals or book chapters and has regularly held presentations in scientific congresses or expert groups.
Sponsored by Charles River
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.
Presented by Erin Patton, Senior Product Specialist, Charles River
Erin received her Bachelor of Science degree in biology from Xavier University and her Master of Science degree in cell and molecular biology from the University of Illinois, Urbana-Champaign. Erin has over 14 years’ experience in molecular biology research, microbiology QC, and regulatory compliance. As a Senior Product Specialist for Charles River’s Microbial Solutions division, Erin provides innovative rapid micro solutions for endotoxin testing, microbial identification, and microbial detection (Celsis rapid bioburden and sterility testing). She is based in St. Louis, Missouri.