NGS for Critical Quality Attribute Assessment of Biological Products: Considerations and Outcomes

Genedata gave a talk at Omics Analysis Technology in Bioengineering Seminar "NGS for Adventitious Agent Detection and Critical Quality Attribute Assessment in Biopharmaceuticals" hosted by Japan Bioindustry Association.

To receive more information about Genedata in Japanese, please contact japan(at)genedata.com.

Presentation Overview

NGS for Critical Quality Attribute Assessment of Biological Products: Considerations and Outcomes
Thomas Hartsch, Ph.D., Head of Genedata Selector Business Unit, Genedata AG

Next-Generation Sequencing (NGS) is a transformative option for adventitious agent detection and critical quality attribute (CQA) assessment due to its speed, sensitivity, and unbiased nature. Maintaining in-process critical quality attributes is necessary to ensure the timely delivery of safe and effective biologically derived therapeutics. Currently used approaches for monitoring CQAs have limitations that are solvable with next-generation sequencing (NGS). Genedata Selector^® is an end-to-end enterprise software solution streamlining NGS-based assays for vaccine, antibodies, Advanced Therapy Medicinal Product (ATMP) development and manufacturing. The software automates and standardizes NGS-based assays and bringing life-changing treatments to production faster.

You can find more information and videos about the Genedata Selector here.