Biologic products cultivated in environments that pose diverse risks to product quality and safety require testing to mitigate the risk of contamination throughout the manufacturing process through to final drug product. Assuring the integrity and purity of your product during cell line characterization and cell bank release testing is integral to any viral safety strategy.

Traditional animal- and cell-based detection methods often fall short in turnaround time, sensitivity, and specificity in the identification of adventitious agents and viruses -- especially unknown viruses, leading to potential contamination risks. For short shelf-life products or those requiring rapid turnaround time for testing, such as cell therapy products, time to result is critical.

We have developed an NGS approach that focused on robust viral detection beyond the species level where available. This is complemented with a secure bioinformatics approach for rapid viral identification using a proprietary analysis platform comprised of multiple curated viral databases. This provides a tested pipeline, designed for speed, accuracy, and comprehensive virus databases for identification, while maintaining Good Manufacturing Practices (GMP).

In this webinar, we will discuss:

• The limitations of traditional in vivo viral detection methods
• How Next Generation Sequencing addresses the critical gaps to replace HAP, MAP, RAP, and in vivo apparent virus testing
• Bioinformatics analysis for rapid viral identification

Presenters:

	Victor Muthu, Ph.D. NGS Group Leader Eurofins BioPharma Product Testing
Victor Muthu, Ph.D. is a Group Leader at Eurofins BioPharma Product Testing. Dr. Muthu has led the implementation of Next Generation Sequencing (NGS) and molecular biology analytical methods tailored for cell and gene therapies in his previous roles. He joined Eurofins in 2023, where he continues to shape the integration of cutting-edge sequencing technologies into biopharmaceutical development, including adventitious agent detection in drug products for cell line testing/characterization of cell and gene therapies and vaccines.
	Jalal Siddiqui, Ph.D. Senior Bioinformatics Scientist Eurofins Viracor
Jalal Siddiqui, Ph.D. (Biophysics, The Ohio State University) is a Senior Bioinformatics Scientist at Eurofins Viracor. Dr. Siddiqui has extensive experience in handling complex omics data and has developed numerous bioinformatics tools/pipelines. During his three years with Eurofins, Dr. Siddiqui contributed to several oncology, infectious disease, and post-transplant clinical care related projects.

Moderator:

Christopher E. Schmidt Senior Scientific Advisor Eurofins BioPharma Product Testing

Christopher Schmidt holds a bachelor’s degree in biology from the University of Georgia and is a seasoned leader in the clinical and biotech industries with over 20 years of experience. Currently serving as Senior Scientific Advisor at Eurofins BioPharma Product Testing, Chris leverages deep technical knowledge in GMP biosafety services—including viral clearance, cell bank production & characterization, sequencing, viral safety, and bulk lot release testing—to assist clients in meeting their regulatory requirements with high quality testing.