Genedata Selector for NGS-Based Biosafety Testing

Genedata Selector for NGS-Based Biosafety Testing INDUSTRY Next-generation sequencing (NGS) is becoming increasingly important for the rapid identifi- Biopharmaceutical R&D cation of contaminants introduced during biopharmaceutical development and manufacturing. Key advantages of NGS are faster, more accurate, and more sensitive results compared APPLICATION Adventitious Agent to traditional methods (Figure ). Manufacturing groups recognize that it is crucial to screen Detection for adventitious agents (e.g., viruses) regularly as failure to detect them early can have dev- Cell-line Stability astating financial consequences. Especially for evolving cell and gene therapy approaches where there are only short time frames between manufacturing and delivery to patients, KEY CHALLENGE efficient and rapid biosafety testing with NGS is crucial. NGS data analysis SUMMARY Assessing the presence of adventitious agents using NGS provides scientists with an unbi- Genedata Selector ased approach, as sequencing detects all organisms. This approach is suitable for testing automates NGS-based starting materials, unprocessed bulk harvest, and the final product. Prerequisites of an NGS- biosafety data processing, based biosafety assessment include sequence data, reference genomes of the production analysis and report host, and a reference database of adventitious agents (e.g., rVDB, etc.). These need to be generation. analyzed efficiently using sophisticated algorithms to gain actionable scientific insights. GENEDATA SOLUTION Genedata Selector® is an end-to-end software solution that enables biopharmaceutical R&D organizations to make data-driven GO/NO-GO decisions regarding product safety, quality, and integrity with significant time savings. By providing out-of-the-box bioinformatics pipelines for automated NGS data processing and analysis, Genedata Selector empowers scientists to implement biosafety testing in house without the need for extensive bioinformatics training. PRODUCT OVERVIEW • GENEDATA SELECTOR® • NGS-BASED BIOSAFETY Challenges Standardizing Reporting for Collaboration and Compliance Developing a Robust Assay It is often laborious and time-consuming for quality control To develop a robust adventitious agent detection assay, teams to compile reports from results generated using a sample preparation and experimental design need to be op- wide variety of assays, including NGS-based assays, and to timized as they influence the sensitivity of the assay, limit of find all the relevant information for a particular sample. To detection (LoD) as well as the false positive and false nega- eliminate any delays in the delivery of documentation to part- tive rate. Biopharma R&D organizations require in-depth data ner organizations or regulatory authorities, a data integration analysis expertise to support their NGS assay development. platform with easy to configure reports is required that can also be validated in a GxP environment. Establishing Efficient Analysis Pipelines NGS-based biosafety testing is often outsourced, leading Keeping Reference Databases and Analysis Pipelines Up to Date to delays in obtaining results and losses in productivity. As An up-to-date reference database, as well as a well anno- Biopharmaceutical R&D organizations establish NGS-based tated genome sequence of the production host, is key for biosafety testing internally, a scalable software solution is obtaining accurate and reliable biosafety test results. Also, required to process and analyze the large quantities of com- data analysis pipelines need to be scientifically proven, plex data yielded by NGS-based assays. transparent, and generate reproducible results. To fulfill reg- Traditional viral safety tests methods require approximately 4–5 weeks. NGS based Adventitious Agent Detection is faster and more versatile than traditional tests. Adventitious Agent Detection involves 3 stages: 1. Sample registration 2. Automated data analysis 3. Report generation. The sample status card in Genedata TRADITIONAL TESTING NGS-BASED BIOSAFETY Selector displays an overview over the processing status. EXTERNAL SERVICE IN-HOUSE TESTING SAMPLE REGISTRATION DATA ANALYSIS REPORTS & DATA MANAGEMENT ALL FIGURES ABOVE ARE DRAFT PRODUCT OVERVIEW • GENEDATA SELECTOR® • NGS-BASED BIOSAFETY ulatory requirements, Biopharma R&D organizations require tation of NGS-based biosafety testing in a broad variety of a professional software solution that maintains up-to-date environments (Figure ). reference databases and analysis pipelines and includes a reproducible curation process for viral sequences, variants of End-to-End Workflows for Automated NGS Data Processing interest, and new mycoplasma strains. The processing and analysis of large, complex NGS data- sets is standardized and automated using workflows within Genedata Selector (Figure ). After a bioinformatics pipeline Solution is adapted to a particular workflow, it can be locked down Assay Development Support throughout Implementation for implementation in a regulated environment. Genedata Genedata provides data science services to guide assay Selector also equips every scientist independent of their development as well as in-depth training enabling you to bioinformatics knowledge, to analyze data from NGS-based operate independently and efficiently with the Genedata Se- biosafety testing and draw conclusions to quickly advance lector platform. Scientific consultants with extensive domain production processes. The software simplifies bioinformat- expertise are available to assist in transitioning into a GMP ics analysis through “Playbooks” (Figure ); step-by-step environment. In addition to providing the software solution, guides enabling sample registration, simple NGS data up- Genedata technical consultants ensure seamless implemen- load, and analysis. Playbooks within Genedata Selector are simple user interfaces designed to automate complex workflows and guide lab personnel through sample registration. An example of a data analysis workflow. Genedata Selector produces time- stamped reports and can follow a 21 CFR part 11 compliant operation, required to integrate the workflow into a GMP environment. As a member ot the FDA-driven Advanced Virus Detection Tech- nologies Interest Group (AVDTIG), Genedata participates in regular discussions with stakeholders in the field, remaining up to date on changing regulations and the needs of the biopharmaceutical industry. PRODUCT OVERVIEW • GENEDATA SELECTOR® • NGS-BASED BIOSAFETY End-to-End Software Solution for NGS-based Biosafety Testing NGS experiments. This results in efficient decision-making Genedata Selector is an enterprise software solution, en- based on informed scientific insights. A process that would abling scientists and laboratory staff to integrate, manage, otherwise require several weeks, can be accomplished in and analyze NGS data. The software consists of modules only a few days using Genedata Selector, accelerating the tailored for NGS-based biosafety testing including: development and manufacturing processes of biotherapeu- • Tracker, for efficient sample management, tracking, analysis tics. automation and report generation • Processor, for accurate, reproducible data processing Transparency and Reporting • Explorer, for efficient data management, visualization of Genedata Selector provides comprehensive data traceability results and knowledge sharing and reproducibility for all biosafety analyses performed. The Genedata Selector supports 21 CFR part 11 compliant envi- data analysis and underlying data processing workflows are ronments. With the software, data processing workflows can transparent and can be configured as needed. Throughout be integrated into a GMP environment by providing time- experimental processes, sample history is also tracked in stamped reports, audit logs, user and access controls, and the database (Figure ) and can be used to generate detailed other supporting features. reports for internal assessment or submission to regulatory authorities as needed (Figure ). Support for Maintenance of Reference Viral Database Beyond software, our scientific consultants provide support Protected Intellectual Property to curate reference databases ensuring the results generated Using your proprietary host cell genome sequence rath- during NGS-based assay experiments are accurate. This abil- er than a publicly available sequence has been shown to ity to oversee all processes from assay generation to data increase the accuracy of results. Genedata Selector equips analysis with proprietary host cell genomes using Genedata scientists to undertake NGS-based biosafety completely Selector provides you with greater transparency and control. in-house so there is no need to share proprietary host cell line genomes with service providers. When using Genedata Benefits Selector for biosafety assessment, IP related proprietary A High-Performing Assay at a Reduced Cost per Sample data never needs to be sent away to outside vendors. In comparison to outsourcing the entire process to third-par- ty service providers, in house NGS-based biosafety testing Summary is cost-efficient, fully traceable, and scalable. By using Genedata Selector empowers scientists to assess the safety Genedata Selector, scientists benefit from additional appli- and integrity of biopharmaceutical products independently cations supported by the software such as cell line stability rather than outsourcing to service providers. While maintain- assessment, gene insert verification, and product integrity

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