Identify and quantify adventitious agents present in your sample
The safety of vaccines, monoclonal antibodies, cell and gene therapy products and other biologically-derived products is strictly regulated and required for a product release. Specific in vivo and in vitro assays are utilized to assess the purity of biologics. However, performing numerous tests on each product requiring clearance is laborious, lengthy and expensive. Implementing Next Generation Sequencing (NGS) within your safety testing program offers unparalleled specificity, reliability, accuracy and speed.
How do you guarantee that your biologically-derived product is free from adventitious agents, like viruses, bacteria, mycoplasma, fungi?
GenomeScan now offers Next Generation Sequencing-based assays that enable unbiased detection of all contaminants, with unparalleled sensitivity, specificity, reliability, and speed.
Recently, our team of Bioinformaticians designed a robust pipeline that was benchmarked against several commonly used Bioinformatics-workflows.
Are you curious how our pipeline performs?
Fill out the form below to download the benchmark report
NGS is a unique, unbiased approach that detects both known and unknown contaminants. It is unmatched by conventionally applied methods. Notably, detection of adventitious agents with NGS is encouraged by the World Health Organization (WHO), European Pharmacopeia (Ph. Eur.) and U.S. Food and Drug Administration (FDA). With our proprietary sample preparation, combined with tailored sequencing and bioinformatics solutions, we enhance your quality control throughout the entire manufacturing process.
Our assays are compatible with a wide range of products (raw materials, ancillary reagents, virus seeds, cell substrates, cell banks, pre-production cells, pre-filtered harvest, post-production cells, control cells, post-filtered harvest and final product), and have the capacity to identify a contamination of any origin, whether it is viral, bacterial or fungal.
Our NGS-based solutions for detection of adventitious agents:
- replace multiple tests with a single, comprehensive assay
- de-risk and accelerate your manufacturing processes
- improve sensitivity and accuracy of your biosafety testing
- reduce costs