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 programme offers unparalleled specificity, reliability, accuracy and speed. 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.
Comprehensive Viral Panel
Use of biologically-derived material in biomanufacturing carries significant risk of viral contamination. Viruses can infect and replicate within living cells, potentially contaminating the final product and rendering it unsafe for use. Viral clearance is, therefore, a crucial step in biomanufacturing pipeline.
NGS offers an unparalleled level of sensitivity and accuracy for detecting and identifying viruses, making it an essential tool for biomanufacturers seeking to maximize the safety and efficacy of their products.
Our Comprehensive Viral Panel, a hybridization-based target enrichment solution, is capable of detecting > 3,000 different viruses, including > 15,000 viral strains in a single reaction. Our proprietary workflow can detect viruses of all genome types: single-stranded RNA, double-stranded RNA, single-stranded DNA, and double-stranded DNA.
Are you curious about clinical diagnostics and pharma / biotech applications of our Comprehensive Viral Panel? Download the technical leaflets below.
Request a full list of viruses detected by our Comprehensive Viral Panel here.
Direct viral metagenomics
In contrast to targeted approaches, direct viral metagenomics solution involves extracting and sequencing genetic material (either DNA, RNA) or both from the sample, which is then analyzed using our proprietary bioinformatic tools to identify and classify viral sequences. The goal is to detect and characterize the diversity and abundance of viruses, including those that may be previously unknown. This technique is “agnostic” because it does not require prior knowledge of the viral genomes that may be present in the sample. It is, thus, particularly useful in identifying novel strains.
Are you curious how our metagenomics pipeline performs compared to several commonly used bioinformatics workflows? Download the benchmark report below.
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
We have summarized key information about our detection of adventitious agents service into a service specification sheet.
Let's get the conversation started for your next NGS project
Let us help you to design and implement a comprehensive detection of adventitious agents programme tailored to your specific requirements. Please fill out the form below or email us directly at geneticQC@genomescan.nl and we will get in touch with you to discuss your requirements.