JOINT WEBINAR

Takeda, PathoQuest & Charles River Laboratories

 

Adventitious Agent Testing For MMV:

How Much Do We Really Know?

 

01st October 2024

10:00am EDT / 7:00am PDT / 3:00pm BST / 4:00pm CEST

Presented by:

Maria Farcet, Head of Cell Culture, Virus Models & Serology in the Global Pathogen Safety /

Global Quality Team at Takeda

featuring

Amina Cherif Louazani, Ph.D., Viral Safety Manager at PathoQuest

and

Dr. Denise Teber, Scientific Expert of the PCR department at Charles River Laboratories

Minute virus of mice (MMV) has contaminated biotechnological processes in the past, making specific MMV testing recommended if the production cell line is known to be permissive for this virus. Testing is widely done using cell-culture based adventitious virus assays, yet MMV strains may differ in their in vitro cell tropism. Here, I present growth characteristics of different MMV strains on A9 and 324K cells and identified significant differences in susceptibility of these widely used indicator cell lines to infection by different strains of MMV, which has implications for MMV detectability during routine testing of biotechnology process harvests[1].

An MMV specific PCR was evaluated as a more encompassing method and was shown as a suitable replacement for cell culture-based detection of the different MMV strains. This method not only provides more rapid detection but also covers other rodent parvoviruses that might contaminate biotechnological processes. Although no MMV contamination event of human-derived cell lines has been reported in the past, biotechnological processes that use these lines, such as HEK293, commonly used in biopharmaceutical manufacturing, also need to consider MMV-specific testing as we showed them to be susceptible to productive MMV infection.

[1] Farcet et al., Biotechnology & Bioengineering 2024; 121:131-138; DOI: 10.1002/bit.28573

Maria Farcet

Head of Cell Culture, Virus Models & Serology in the Global Pathogen Safety / Global Quality team at Takeda

Maria Farcet is Head of Cell Culture, Virus Models & Serology in the Global Pathogen Safety / Global Quality team of Takeda in Vienna, Austria. In her 15+ year career in this field she gained profound expertise in virology and virus safety margins of biological medicinal products.  She currently oversees the establishment and operation of virus test systems to enable virus reduction studies, virus testing and virus neutralization assays, under GMP/GLP.

Amina Cherif Louazani, PhD

Viral Safety Manager at PathoQuest

Amina Cherif Louazani (PharmD, PhD), Viral Safety Manager at PathoQuest, has a strong background in virology and bioinformatics. She holds a PhD in Infectious Diseases from Aix-Marseille University, France, and specializes in NGS data analysis and protocol development for viral transcriptomes. Amina has published several peer-reviewed articles and held various research and clinical roles. At PathoQuest, she leverages her expertise to provide expert reviews of viral safety assessments based on the iDTECT® platform of NGS assays.

Dr. Denise Teber

Scientific Expert of the PCR department at Charles River Laboratories

Dr. Denise Teber is the Scientific Expert of the PCR department at Charles River, Erkrath, Germany. She is responsible for the establishment of new qPCR and ddPCR assays for the detection of pathogens or process-related biological impurities, as well as method validation of platform assays or client-specific requests. She has a biology degree from the University of Münster and a Master’s degree from the University of Cologne. During an external master thesis at the German Aerospace Center (DLR), she investigated the influence of ionizing radiation on cell cycle progression to predict its harmful impact on astronauts on the International Space Station – ISS. During her PhD and post-doctoral work at the Max Planck Institute for Molecular Biomedicine in Münster, she used lentiviral and adenoviral vectors to induce putative mutations causing venous malformations in isolated primary mouse endothelial cells and analyzed their effects by qPCR, co-immunoprecipitation and western blot as well as intravital microscopy.