Next Generation Sequencing for Complete Biological Insight
Next Generation Sequencing (NGS) is a revolutionary technology that combines detection and sequencing of any kind of nucleic acids. The sequence information can be used to detect and identify specific targets like viruses or genetic sequences without upfront information as it is needed for PCR approaches. This technology is pivotal in genetic characterization and identity testing of Gene therapy based medicinal product and in the detection of pathogens in any kind of biologics. With its high throughput, scalability, and speed, NGS has transformed the landscape of genetic analysis and pathogen detection.
Through our partnership with PathoQuest, we have expanded our comprehensive portfolio to include Next Generation Sequencing services to pharmaceutical and biotech companies. Our NGS services include viral contamination testing and genetic characterization of cell lines used for production of biologics and cell and gene therapy products. We can provide GMP and EMA compliant solutions ensuring high acceptance by regulatory bodies.
Next Level Viral Safety Testing
Biologics are vulnerable to viral contamination, posing risks to patient safety. This whitepaper discusses traditional detection methods and their limitations and demonstrates how validated NGS technology can enhance viral safety testing, ensuring reduced risk and expedited market access.
Read the whitepaper
Benefits of our NGS Services
- Very low sample volumes are needed for testing
- Faster turnaround times to meet tight clinical timelines
- Robust and powerful bioinformatics tools including an automated BioIT pipeline
- Powerful substitute to animal testing
- Ability to identify a broad range of viruses, including still unknown viruses
- Opportunity to replace multiple standard virus tests with one NGS assay
- Discriminating infectious virus from non-replicating carryover or dormant virus
- More efficient and comprehensive genetic characterization of production cell banks and gene therapy products
- Accelerate your drug development by ensuring fast, comprehensive safety testing package
NGS Applications
Our collaboration with PathoQuest has allowed us to enhance our extensive service offerings by incorporating Next Generation Sequencing services for pharmaceutical and biotech companies addressing a broad range of products including critical start materials. We have different approaches to your testing depending on the source material and the desired outputs. Our NGS services include a faster, safer, animal free viral safety testing of raw materials, cell banks and bulk harvests with iDTECT® Transcriptome and iDTECT® Virome. For genetic characterization we offer a simpler, more certain genetic characterization of cell banks, plasmids, and virus lots with iDTECT® Identity and iDTECT® Integration Site Analysis.
Our GMP NGS services assays and bioinformatic approaches are designed to accelerate adventitious agent detection and bioprocess characterization enabling the safe and high-quality production of biopharmaceuticals. Our team can provide comprehensive testing services for a wide range of modalities.
"Next generation sequencing (NGS) is the ultimate viral safety testing technology and is about replacing several standard testing tools. NGS should be applied for products without viral clearance capabilities and for cell therapy products specifically where the standards testing tools can fail to detect critical viral contaminants."
Horst Ruppach, Executive Director Scientific Portfolio Biologics
Viral Vectors
Our Next Generation Sequencing services offer comprehensive viral vector services, including viral safety testing and plasmid screening, to ensure the safety of these therapies. Viral vector characterization is essential to ensure the quality and efficacy of these therapies. Viral vectors can be used for a range of applications, from direct in vivo gene delivery in genetic therapies to in vitro transduction for gene-modified cell therapies such as CAR-T, as well as oncolytic applications. Manufacturing the virus can be very complex, involving critical input materials such as plasmids. Plasmid screening is necessary to identify and verify the plasmids used in the production process.
Next Generation Sequencing for Adventitious Virus Testing
Next Generation Sequencing approaches have been developed to detect live viral contaminants in cells, and regulatory bodies are encouraging its use as a replacement for in vivo assays.
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Cell and Gene Therapy
For cell and gene therapy companies, we offer GMP characterization and release tests for many cell therapy applications. Traditional testing can require large volume of samples which can be hard to come by. By using our Next Generation Sequencing services, you can overcome volume and compatibility issues with traditional animal or cell-based testing giving you more samples to use for life-changing cell therapies to patients. Our NGS services include Cell Therapy quality control, iPSC characterization, stem cell characterization, and CAR-T Release Testing, ensuring that every therapy meets the highest standards of safety and efficacy.
Regulatory agencies have accepted NGS as an alternative to the in vivo adventitious virus testing strategies, depending on a risk assessment. ICH Q5A(R2) 3.2.3: NGS is encouraged as a replacement for in vivo assays due to its enhanced detection capabilities and alignment with global objectives to reduce animal testing.
The future of Cell Therapies: Are you using the best tools for success?
Next Generation Sequencing is the modern solution best suited to the complexities of developing donor-derived cell therapies, offering many advantages over traditional Polymerase Chain Reaction.
Read Feature Article
Cell Line Characterization
Next Generation Sequencing 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 Charles River and PathoQuest's expertise in microbiology and virology, combined with Illumina’s state-of-the-art NGS sequencing platforms, makes us a unique solution provider to assess the safety of your cell lines and virus stocks.
We offer Next Generation Sequencing services on Nanopore MinIon, MiSeq, or NextSeq of STR (single tandem repeat) for DNA fingerprinting, insert, or targeted sequences comparison. For full genome sequencing we offer services on Luminex, MiSeq or NextSeq systems and de novo assembly or comparison to a reference sequence in a rapid turnaround time. 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 and is currently available on demand.
mAbs and Recombinant Proteins
Monoclonal antibodies demand a comprehensive and integrated approach from development to manufacturing requiring specialized QC testing and characterization within a regulated GMP environment. Because of the complex biologics, companies are faced with time-consuming and labor-intensive processes to isolate specific monoclonal antibodies. Our Next Generation Sequencing services provides timely and sustainable results and completely remove animal testing from your product release requirements. Our expertise extends to mAb characterization, CHO cell line characterization, and mAb and recombinant testing.
Vaccines
An important step in vaccine testing is being sure each batch of vaccine meets all safety and efficacy standards. From established recombinant and inactivated vaccine technologies to the emerging RNA and viral vector vaccine platforms, our GMP level Next Generation Sequencing services include vaccine testing, vaccine characterization, vaccine release, and vaccine sequencing. These services are supported by industry-leading expert bioinformatic analysis, giving you ultimate confidence in the analysis of the results.
RNA-based Therapy
NGS is uniquely placed to enable characterization and identification of the RNA product, such as its ability to identify ultra-rare sequence variants, which can be problematic. From pathogen identification to antibiotic resistance mapping, our experts can deliver high-throughput genomics solutions including sample preparation, high quality data generation, analysis, and data interpretation so critical decisions can be made to help advance your products from discovery to development. Our NGS services include mRNA sequencing and RNA sequence analysis, ensuring the highest standards of precision and reliability.
Adventitious Agent Testing For MMV: How Much Do We Really Know?
Experts discuss the current state of viral safety testing and the emergence of broad molecular methods, such as Next Generation Sequencing (NGS), that address some of the gaps in traditional viral safety testing of biologics.
Watch the webinar
Regulatory Support for NGS Services
The greatest perceived challenge to replacing an existing assay with NGS is the concern with regulatory acceptance. We offer regulatory excellence from the R&D stage to the batch release of marketed products with full GLP and GMP-integrated services, from sample preparation to actionable report, including review by an expert virologist or geneticist. Our Next Generation Sequencing services meet the highest regulatory requirements in biotesting, guaranteeing accuracy, reliability, and compliance with GMP, FDA, EMA, and ICH Q5A and Q5B.
Frequently Asked Questions (FAQs) About Next Generation Sequencing Services
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What is Next Generation Sequencing (NGS)?
There are many terms used to describe the technique in which millions of nucleotide sequences are deciphered simultaneously. Next Generation Sequencing is the same as massively parallel sequencing, high-throughput sequencing (HTS), and deep sequencing. These related terms describe a technology which has revolutionized genomic research. With Next Generation DNA Sequencing, an entire human genome can be sequenced within a single day. NGS allows for rapid sequencing of DNA and RNA much more quickly and cheaply than traditional methods like Sanger sequencing.
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What is High-Throughput Sequencing?
While sequencing has traditionally been performed via a low throughput technique called Sanger sequencing, high-throughput sequencing (HTS) technologies are capable of sequencing multiple DNA molecules in parallel, enabling hundreds of millions of DNA molecules to be sequenced at the same time. High-throughput sequencing (HTS) is also known as Next Generation Sequencing (NGS).
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Why Should Genome Sequencing Companies Use NGS?
The primary reason to use Next Generation Sequencing services vs. traditional methodologies is due to the decreased turnaround time that NGS offers. Furthermore, regulatory authorities are advancing support for NGS. It has the potential to replace existing in vitro/in vivo assays and molecular tests:
- It can be used in direct testing of cells, virus stocks, etc. and Bioassay readout
- Non-hypothesis driven
- A broad range of detection
- Differentiates live from inert viruses
