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Your Solution for ICH Q5A(R2)-Compliant Viral Safety

The ICH Q5A(R2) guideline emphasizes the advantages of using highly sensitive NGS (next-generation sequencing) technology for adventitious virus testing as an alternative to in vitro and in vivo animal testing assays. This guideline was implemented by the EMA (Europe) on June 14, 2024, following the implementation by the FDA (USA) in January 2024. This approach helps to reduce the need for animal testing and shortens the time to market.

Genedata Selector® is your trusted partner for seamlessly validating your NGS-based biosafety assays in a GxP environment. As an end-to-end software platform for NGS data management and analysis, Genedata Selector provides out-of-the-box GMP-required functionalities and enables biopharmaceutical organizations to implement various NGS-based assays in-house.

Genedata Selector’s Functionalities for GMP-Compliant Viral Safety

Our commitment lies in keeping the highest standards of expertise and GMP compliance for our customers.

Click below to discover how to simplify and streamline the analysis of your NGS biosafety workflows in-house in a GMP environment with Genedata Selector®.

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Industry Voices - Genedata Selector Podcast Series

Discover the best practices for validated in-house NGS-based biosafety assays with Genedata Selector in our podcast series.

Episode 5: Join our guest, Christoph Bredack, Business Account Manager at Genedata Selector. Christoph shares his experience as a reviewer of the Swiss ICH Q5A and provides insights on the regulatory requirements for NGS assay validation.

Episode 4: Join our guest Siamaque Kazem, Senior Scientist and Team Leader at Johnson & Johnson Innovative Medicine. Siamaque shares his insights on the quality and safety of vaccines in GMP settings, with an emphasis on the increasing importance of NGS-based assays.

Episode 3: Join our guest Aurora Signorazzi, Scientist & Project Leader at Johnson & Johnson. Aurora shares her insights on the validation of in-house NGS-based biosafety assays, and the impact of the ICH Q5A(R2) guideline and the new draft of the 2.6.41 chapter of the European Pharmacopoeia.

Episode 2: Join our guest Ludwig Macko, Head of Development at Genedata Selector. Ludwig discusses his hands-on experience with the process of validating NGS-based workflows in GxP environments.

Episode 1: Join our guest Devon Ryan, Head of Scientific Consulting at Genedata Selector as he shares valuable insights on establishing and maintaining GxP-compliant NGS-based biosafety workflows for biopharmaceutical organizations in the context of the recent ICH Q5A(R2) guideline update.

Connecting the Dots Across R&D Workflows in GMP-Compliant Environments

Genedata Selector is an off-the-shelf digital solution that connects all the dots in the R&D NGS-based workflows. Click on the infographic below to learn more about the platform's various capabilities.

Accelerate Your Biosafety Testing with Genedata Selector

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