Next Generation Sequencing
Revolutionizing the development and analysis of biologic therapeutics, next generation sequencing (NGS) now allows you to meet the challenge of rapidly characterizing your products, while identifying known and unknown agents with pinpoint precision and accuracy. Our suite of NGS services is based on complementary technology platforms that rapidly generate deep sequencing datasets for comprehensive data analysis, backed by biosafety experts who deliver intelligent results tailored to your unique testing needs. Our services include:
Identity testing and variant determination
NGS can be used to characterize and confirm the identity of viral and bacterial seed stocks, as well as expression vectors used in vaccine or gene therapy products. Such identity testing is a requirement of regulatory agencies for biologics intended for human use. Materials that routinely undergo identity testing include viral vectors, viral seed stocks, and bacterial seed stocks.
Our services provide deep sequence coverage, confirming identity and detecting ultra-low-frequency genomic variants often missed through conventional sequencing methods. Advantages include:
- High confidence identity determination
- Discrimination of highly related strains or sub-populations
- High confidence detection and identification of sequence variants, including low or ultralow (1-5% of the population) variants within the population
- Generation of accurate reference sequences
Genetic stability testing
NGS revolutionizes traditional approaches to stability testing by providing all the information needed to meet Q5B guidelines in a single run. Our services deliver state-of-the-art characterization of integrated expression constructs used to produce recombinant DNA protein products in cell systems, offering:
- Integrated construct copy number analysis
- Assessment of the integrity and configuration of the genomic and expressed copies of the integrated construct(s)
- Identification of the location of the integrated construct(s) within the genome
- Host cell line flanking sequence characterization
- Identification of sequence variants within the integrated construct(s)
Adventitious agent detection
Use of NGS for adventitious agent testing enables sensitive, unbiased detection of viral, bacterial, and fungal contaminants in a range of sample types – from raw materials and cell lines to final biopharmaceutical products. Implementation can serve as part of a Quality by Design (QbD) approach or as an unbiased investigatory tool. Adventitious agent detection by NGS provides:
- Support for the reduction of animal usage by replacing in vivo testing
- A sensitive alternative to in vitro testing when appropriate antiserum is not available
- Nimble investigation and remediation of biomanufacturing contamination events
NGS has proven itself to be an effective, alternative method for rapid and comprehensive adventitious agent detection. This is particularly true in instances where the nature and source of the contaminant is completely unknown, or where traditional test methods may not exist. An unbiased, sequence-agnostic approach is well suited under these circumstances and provides numerous advantages.
Customized assays and spiking studies
Our experts have significant experience with the design and execution of custom NGS-based experiments, each tailored to meet your unique needs and requirements. Our scientists are available for consultation to design and execute your next study for the highest data quality, meeting regulatory guidelines.
Bioinformatics
Our experienced team can deliver a range of bioinformatics solutions, from the standard identity algorithm to highly customized service offerings. Examples include:
- Complete sequence analysis/confirmatory analysis
- Mapping and de novo assembly
- Variant detection, including low frequency mutation identification
- Transcriptome analysis (RNA-Seq)
- Differential gene expression
- Custom database creation and BLAST analysis
- Custom algorithm development and validation
- Cloud computing services
- 21CFR Part11 compliant data tracking and storage
Our commitment to your success is backed by:
- Scientific and regulatory support for sample submissions
- Fully validated GMP workflow from sample processing to final report
- Robust bioinformatics pipeline and high-quality reference databases
- Comprehensive data analysis and interpretation
- Secure data management
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