An extensive genetic characterization of cell line is important at all stages of drug development: from the initial transformation to compound production. GenomeScan provides NGS-based tools to accurately characterize the expression constructs that are used in the production of recombinant DNA. Whether you are verifying the sequence of your plasmids or you are seeking to confirm the identity and serotype of your viral vector, GenomeScan will match appropriate solution tailored to your specific needs.

We routinely sequence:

• PCR products
• plasmids e.g. used to generate cell lines, viral vectors
• viral vectors e.g. frequently used in manufacturing of vaccines and gene therapies (adeno-associated viruses, adenoviruses, lentiviruses, retroviruses)

Generation of producer cell lines is not trivial. The transfected gene insert may dramatically affect clonal stability. It is critical to evaluate the insert location (risk of gene disruption at insert site) and to determine the number of inserted copies into the genome. Furthermore, it must be ascertained whether a full or partial insertion of the target sequence has occurred and whether the orientation of the integrated construct(s) is correct.

In any facility utilizing cell lines for development and manufacturing purposes, an extensive genetic characterization of the models used is paramount. Whole Genome Sequencing (WGS) offers the most accurate and extensive characterization of your producer cell line, with an unmatched resolution at the base pair level. To achieve the best results, we recommend using a combination of short and long-read sequencing technologies.

Continuous expansion of cell cultures leads to genetic alterations that often emerge unnoticed. Single nucleotide polymorphisms (SNPs), insertions/deletions (indels) and copy number variations (CNVs), frequently impact the stability of the cell line and its production capabilities. In this context, the classification of the functional consequences of the aforementioned alterations is particularly relevant: a stop-inducing SNP or a synonymous mutation will have very different biological consequences.

Routine monitoring of producer cell lines with NGS is now easily attainable, fast and cost-effective. To ensure stable and consistent production, we recommend authenticating your cell line banks regularly. Our cell line authentication service compares the genetic information of your Working Cell Bank (WCB) or End of Production Cell Bank (EOPC) with your Master Cell Bank (MCB) reference.