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:
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:
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:
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:
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.
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.
Our experienced team can deliver a range of bioinformatics solutions, from the standard identity algorithm to highly customized service offerings. Examples include:
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