The absence of adventitious agents is critical for the quality of pharmaceuticals, where contamination event can arise from starting materials or during production (e.g., cell line, cell substrates, equipment, facilities and/or operators).
Rapid microbial methods offer alternatives to traditional compendial methods: reduced time for testing, reduced sample volume requirement, possible automation, increased sensitivity and accuracy. These technologies are most suitable for products with a short life, limited supply, and urgent needs and which may be infused into patients before the completion of the test.
The presentation will provide a general overview of the official USP RMM chapters and those under drafting or commenting. In addition, the frequently asked questions, general principles and future developments of the USP <72> and <73> chapters will be explained in detail.
Presented by
Dr David Roesti, PhD. Microbiologist/Facilitator QA/QC
Novartis Pharma AG
Dr. David Roesti holds a PhD in microbial ecology from the University of Neuchâtel, Switzerland and has more than 25 years of experience in the field of microbiology. 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. David Roesti is an elected member of the General Chapters Microbiology Expert Committee of the United States Pharmacopoeia 2022-2025 revision cycle and is a member of the advisory board of the European Compliance Academy Microbiology Group. Finally, David 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.
Rapid sterility testing is very appealing to pharmaceutical manufacturers looking to release product and patients eager to receive it. ATP-bioluminescence offers manufacturers the opportunity to release sterile products in as little as 4 days. Establishing that 4-day time to detect was no small feat. Multiple test replicates using a large microbial panel with exceedingly small inocula were analyzed with both the Celsis® ATP-bioluminescence method and the traditional sterility test. This presentation outlines the results of these tests. Included is a look at similar data used to support short-life product release based on the parameters outlined in the newly published USP chapter <73>.
Presented by
Jon Kallay Senior Technical & Market Development Manager
Charles River Laboratories
Jonathan (Jon) Kallay is a Senior Technical & Market Development Manager 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 Bachelor’s degree in biochemistry from Denison University before earning a post-graduate diploma in pharmaceutical microbiology from the University of Manchester.
Followed by a live Question and Answer Session
Sponsored by
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.
