Improved clone selection, genetic characterization, clonality and genetic stability testing
Comprehensive genetic characterization has become mandatory in pharmaceutical cell line development, clone selection and ensuring consistent and safe production of biologicals.
Conventional technologies such as Southern Blot and FISH are costly, time-consuming and do not provide complete information on transgene integrity and integration sites.
Cergentis’ Targeted Locus Amplification (TLA) technology constitutes a paradigm shift in cost-effectively and completely resolving transgene integrity, integration site(s) and concatemers on the single nucleotide level, within 7 working days.
This seminar, recorded during BioProcess International Conference (September 2020), will elaborate on the application of TLA-based assays in cell line selection and characterization of cell banks, clonality and genetic stability as well as its use in regulatory filings. We will discuss some case studies and share recent and upcoming developments in our services and products.
Cergentis supports all leading pharmaceutical companies for genetic quality control of their (CHO) cell line development, gene therapy products and transgenic animal models.
Please contact us for more information.
For an overview of the publications and appnotes cited in the presentation, click here.