In the realm of biopharmaceutical manufacturing, the genetic integrity of cell banks is paramount to ensuring the safety and efficacy of biological products. Traditional methods for testing the genetic stability of CHO (Chinese Hamster Ovary) involve a suite of assays, each designed to address different aspects of cell line characterization as required by ICH Q5B guidelines. These methodologies, while effective, are often time-consuming and complex, demanding considerable resources and expertise. With the advent of the Aptegra™ CHO genetic stability assay, a new era in cell bank testing is emerging.
This innovative assay serves as a comprehensive solution, utilizing whole genome sequencing technology combined with sophisticated bioinformatics algorithms. The Aptegra™ CHO assay transcends conventional testing methods by providing detailed information on the gene of interest, accurate copy number validation, and in-depth analysis of integration sites and flanking regions. Such a holistic approach not only enhances the granularity and accuracy of the data but also significantly expedites the testing process. By amalgamating multiple analyses into a single workflow, the Aptegra™ platform supplies an all-in-one genetic stability profile of CHO cell banks.
Streamlining Biopharmaceutical Development
The Aptegra™ CHO genetic stability assay is revolutionizing how the genetic integrity of CHO cell banks is tested, adhering to ICH Q5B guidelines. Traditional methods, though effective, were laborious and resource-intensive. The Aptegra™ assay, through whole genome sequencing and advanced bioinformatics, delivers comprehensive genomic analysis. It offers insights into the specific gene of interest, validates gene copy numbers, and provides detailed integration site data. This innovative approach consolidates several tests into one, yielding quicker, more detailed genetic stability profiles, and streamlining the cell line characterization process in biopharmaceutical manufacturing. This new technology represents a significant step forward in ensuring the safety and efficacy of biological products.
