Microbial Impact Assessment of In-Process Bioburden Limit Excursions



20th March 2025 | 10:00am EDT / 7:00am PDT / 2:00pm GMT / 3:00pm CET | Friedrich von Wintzingerode, PhD. Director, Microbiology and QC individualized and cell therapy at Genentech, Cheryl Essex, MS. Head of Contamination Control, R&D Global Quality at Sanofi and Jon Kallay, Senior Scientific Portfolio Specialist, Charles River Microbial Solutions |BOOK FREE SEAT FOR THIS WEBINAR

Biologic manufacturing processes are vulnerable to microbial growth, requiring strong contamination controls and in-process bioburden monitoring.

Bioburden in-process limit excursions should be rare but when they occur, the impact from microbial impurities can be unclear. Filtration alone does not remove them and unlike endotoxin, there is no reliable way to detect the full range of microbial by-products, e.g. exotoxins, PAMPs, and proteases. From a patient safety and product quality perspective, the potential impact of microbial contamination must be assessed as part of the investigation.

The biologics industry has not harmonized on a method for conducting microbial impact assessments. This leads to inconsistency in how firms respond to in-process bioburden excursions, particularly when deciding whether to release or to discard the resulting batch.

This presentation will highlight the specific challenges and best practices for assessing the potential product quality impact of an in-process bioburden contamination, including two distinct approaches: a quantitative method built on extensive studies of Roche/Genentech, and a qualitative approach focused on process vulnerability from PDA TR. 90.

Presented by Friedrich von Wintzingerode, PhD. Director, Microbiology and QC individualized and cell therapy at Genentech

Friedrich is Director, Microbiology and QC individualized and cell therapy at Roche-Genentech.

Friedrich joined Roche-Genentech after earning his PhD in Microbiology and has over 23 years of experience in Quality Control and Quality Assurance in the biopharmaceutical industry, working on various topics including microbiological testing, material specifications, environmental monitoring, cleaning analytics, and analytics for release. 

Friedrich has led several global technical teams (e.g. microbial identification, microbiological testing, endotoxin testing, and Low Endotoxin Recovery/LER) at Roche-Genentech and co-chaired the PDA LER Task Force, which authored PDA Technical Report No 82. 

Friedrich is chair of the PDA ATMP advisory board and member of the USP Microbiology Expert Committee.

Cheryl Essex, MS. Head of Contamination Control, R&D Global Quality at Sanofi

Ms. Essex is a recognized global expert in microbial contamination control at Sanofi. She co-led the PDA Technical Report 90 on Contamination Control Strategy. Ms. Essex has 20 years’ experience in Quality focused on Microbiological Contamination Control at large pharmaceutical companies, contract manufacturers, and emerging biotechnology working in mammalian, microbial and human cell systems. Ms. Essex’s undergraduate education focused on Biology & Microbiology and she holds graduate degrees in Bioengineering & Stem Cell Medicine.

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

Jon Kallay, Senior Technical & Market Development Manager, 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.


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