,,Our Service Offer to BioPharmaceuticals Industry
Applications for Next Generation Sequencing (NGS)
Adventitious viruses can contaminate biopharmaceutical production systems and go undetected with consequent risks to the final product. NGS testing is a technique which does not require targeted primers to look for viral contamination instead it is able to scan millions of RNA/DNA sequences concurrently. After sequences of interest are identified, bioinformatics are used to scan through these sequences and determine matches to known viruses and also have the potential to identify new, unknown viruses. Confirmation testing for NGS “hits” can then be done via targeted PCR approaches.
Our NGS-based adventitious virus testing approach uses a process called metagenomics to provide a more sensitive and comprehensive method to the identification of pathogens, a GLP graded service level is available.
Our advanced approach permits the identification of pathogens from production samples such as:
· Vaccine & Virus Stocks
· Eukaryote Cell Banks
· Prokaryote Cell Banks
· API & Raw Material
· Investigational materials
Genetic Stability Testing/Cell Line Characterization
NGS permits parallel sequencing of millions of DNA fragments and is now recognized as one of the most powerful and reliable tools for full genome sequencing. The combination of PathoQuest’s expertise in microbiology and virology combined with Illumina’s state-of-the-art NGS sequencing platforms makes us a unique solution provider for your studies on cell lines and virus stocks when looking at cell line identity and/or purity (monoclonality) evaluation.
We offer sequencing on Illumina’s MiSeq® and NextSeq® Systems as well as Oxford Nanopore’s MinION® using STR (single tandem repeat) for DNA fingerprinting, insert, or targeted sequences comparison. For full genome sequencing we offer services on the MiSeq or NextSeq systems and de novo assembly or comparison to a reference sequence in a fast turnaround time.
The full suite of services for cell line characterization includes:
· Characterization of novel cell lines used in production process (e.g., vaccines)
· Full genome sequencing
· Cell identification (STR)
· Clonality testing
· Genetic drift studies
· Cell re-engineering
The use of NGS for these purposes allows you to run one study instead of having to perform multiple assays to achieve the same comprehensive results.
NGS metagenomic approaches also enable the testing of all biological media and other components that are used in the development of biologics from the R&D stage to the batch release of marketed products, including investigations in the case of a contamination. By including raw material testing in your viral safety package, you lower your risk of finding a contaminant later in your production processes.