Application of Next Generation Sequencing (NGS) Based Methods for Detection of Viral Contaminants in Biomanufacturing


21st October 2021 | 10:00am EST | Jurgen Mullberg Associate Director at Bristol Myers Squibb |BOOK FREE SEAT FOR THIS WEBINAR

Contamination of a biological product with viruses, potentially harmful for humans, is of concern for therapeutics derived from human and animal sources, i.e. plasma, and for protein therapeutics and vaccines produced in mammalian cells.  More recent “Advanced Therapeutic Medicinal Products (ATMPs)”, such as gene and cell therapies, share the same concern.  Tests for viral contaminants are performed at several stages of manufacturing.  Current tests for the detection of viruses are lengthy; cell culture based assays and animal experiments are required.  Alternative molecular tests, such as “next-generation sequencing (NGS)”, provide faster results, and can eventually replace in vivo animal studies.  It is noteworthy that identification of a viral contaminant that evaded detection in classical tests, by NGS, has been demonstrated.  In addition, due to the fast turnaround time, the application of targeted NGS for “in process” detection of viral contaminants can be envisioned.  Current efforts for the development of unbiased and targeted NGS based viral safety assays will be discussed

Presented by Jurgen Mullberg Associate Director at Bristol Myers Squibb

Jürgen received a Ph.D. in Biology from RWTH Aachen in Germany. He studied molecular mechanisms of inflammation and immune modulation in both, academia and biotech. His previous work in Biopharmaceutical firms (Dyax & Novartis) focused on the expression of therapeutic proteins and vaccines in mammalian cell culture. Currently, Jürgen serves as network viral safety SME at Bristol Myers Squibb and provides guidance on adventitious agent control and safety of manufacturing processes and cell substrates.

Followed by Audrey Brussel, Ph.D. Viral Safety Leader at PathoQuest and company representative to the International Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB).

Audrey has 20 years of experience in the virus safety field applied to the industry. She recently was Project Leader for the Corporate Biological Safety Unit of LFB where she was responsible for promoting operational excellence and continuous improvement in pathogen safety. She previously worked at Sanofi and Texcell, a French CRO specialized in viral safety and she is actively participating in numerous international viral safety working groups and has chaired and presented at international conferences in her field of expertise.

She is strengthening PathoQuest’s in-house expertise in viral safety. Her insights and knowledge of the pharmaceutical industry from a customer’s perspective are helping the company to deliver better services and support the rapid growth and assessing the expansion of the quality control testing business for biologics.

Audrey received her Ph.D. in Virology/Genetics from the Paris VI University and she was a virology post-doctoral fellow at Institut Pasteur of Paris

 

Sponsored by PathoQuest

PathoQuest Your genomic expert for biologics testing

Robust and efficient Quality Control testing is critical for the development of biologics to reduce time to market and improve patient outcomes.

Developers and producers need QC testing solutions that help de-risk their product development pipeline by preventing adventitious agent contamination and cell line misidentification.

To meet those objectives, PathoQuest offers advanced Next Generation Sequencing (NGS) solutions that supplement or replace traditional methods and support the strategic decision-making process. This innovative approach allows for a robust and unambiguous level of testing and for faster turnaround time and is available with R&D, GLP and GMP grade.


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