Clonality assurance assay and genetic stability analysis
UTRECHT, THE NETHERLANDS - August 27, 2020. Cergentis, a genomics company that develops and commercializes kits and services based on its proprietary Targeted Locus Amplification (TLA) technology, today announced the expansion of its product portfolio with new service packages for cell line development: clonality assurance package and genetic stability package. These packages rely on Cergentis’ TLA technology for transgene and integration site sequencing and provide reliable, single-nucleotide information on the genetic composition of producer cell lines.
To ensure consistent quality in the production of any pharmaceutical biologic, assurance of clonal derivation of producer cell lines is a regulatory requirement by both FDA and EMA and vital to ensure product quality and patient safety.
Assessing clonality can nowadays be done using various methods. However, such assessments can be time consuming and costly or may not have been possible during the generation of older 'legacy’ cell lines. Rederiving these cell lines is generally to be avoided.
TLA combined with qPCR-based breakpoint analysis can provide assurance of clonality within 10 weeks, thereby filling a gap in the need for a reliable, quick testing method. Technical details can be found in our new white paper: Targeted Locus Amplification and NGS combined with qPCR-based breakpoint analysis for the assurance of monoclonality in recombinant cell lines.
Besides clonality, assessing the genetic stability of producer cell lines is equally important. Cergentis provides a genetic stability assessment package in which TLA is used to gain genetic insight into the genetic stability of producer cell lines, ensuring consistent production of biologics.
Joris Schuurmans, CEO of Cergentis, commented: "We are very excited to be launching these new service packages. It addresses the increasing demand of our current customer base to adopt these services into our TLA-based genetic engineering portfolio and enables us to support our customers even better in their cell line development work.”
Cergentis is a genomics company that develops and commercializes TLA-based diagnostic kits for targeted complete next-generation sequencing of (trans)genes and gene editing events. The company also provides commercial services for leading research institutes and pharmaceutical companies worldwide. TLA is a well-established technology that provides unique and critical advantages in the implementation of personalized medicine and advanced genetic engineering. For more information: cergentis.com.