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



21st October 2021 | 10:00am EST / 3:00pm GMT / 4:00pm CET | Jurgen Mullberg Associate Director at Bristol Myers Squibb and Joanna Zmurko, NGS specialist at PathoQuest |WATCH FOR FREE

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 Joanna Zmurko, NGS specialist at PathoQuest

Joanna Zmurko has over ten years of professional experience in virology in the CRO environment. She combines a strong scientific background with a broad technical knowledge in molecular biology. She was able to develop her compelling business acumen while serving as Virology Biosafety Scientist at Merck KGaA. Before joining PathoQuest, Joanna held a Business Development role at Q2 Solutions (IQVIA’s testing laboratory). Joanna Zmurko is now a Sales Manager, NGS Specialist at PathoQuest. In her role, she advises on and provides solutions for pharma, biotech, and C(D)MO clients on NGS-based assays as viral safety testing for biologics, vaccines, and AMTPs. Joanna trained as a virologist through Marie Curie Research Fellowship in Virology at Katholieke Universiteit Leuven in Belgium, focusing on flaviviruses such as dengue and Zika.
 
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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