Based on more than two decades of expertise in the field of gene editing, gene- and immunotherapy GeneWerk GmbH was founded 2014 in the heart of biotechnology metropolitan area Rhein-Neckar, Germany. Our business partners appreciate our worldwide unique experience in assessing vector safety and efficacy in gene therapy and immune repertoire studies as well as assistance in associated regulatory demands. Thereby we provide highly sensitive technical platforms and bioinformatics to determine fusion sequences adjacent to known DNA or RNA fragments in minimal tissue samples down to single cell level.
Applications include clonality and safety of viral vectors in gene therapy, on-target specificity of designer nucleases, immune repertoire studies in T and B cells and Next Generation Sequencing. Operating within several consortia (e.g. SCIDNET, CRACK IT) allows us to focus on our mission - to improve the safety of novel gene therapy products for patients and help reducing the reliance on animal models.
GeneWerk Product Line provides modular services where client data are processed under high quality standards in validated analysis pipelines:
Integration Site Analysis of Viral Vectors via (nr)LAM-PCR
Identification of viral vector flanking genomic sequences at GeneWerk is performed with linear amplification mediated PCR (LAM-PCR) (Schmidt et al Nat Meth 2007). Optionally, non-restrictive LAM-PCR (nrLAM-PCR) is applied (Gabriel et al Nat Meth 2009, Paruzynski et al Nat Protoc 2010). Subsequently our experts process the data according to clients’ needs using our semi-automated bioinformatics tool suite.
Integration Site (IS) Analysis via Target Enrichment Sequencing (TES)
GeneWerk applies new approaches to identify viral vector IS based on NGS. Referring to our unique experience with cancer genomics studies we offer partial or complete vector genome TES. Results yield information on clonality, quantitative individual clonal contributions and vector genome stability. Enrichment of cellular subgenomic DNA in parallel to vector sequences further allows definition of vector copy number in sample.
Gene Editing On-/Off-Target Analyses
Gene Editing is based on designer nucleases that allow targeted insertion of genetic material into specific loci of the mammalian genome. Off-target analyses based on (nr)LAM-PCR or TES may be performed using sequence information of target genomic locus or of applied donor sequence (Gabriel et al. Nat Biotech 2015). Bioinformatically defined off-targets are analyzed by locus-specific PCR based NGS.
Im Neuenheimer Feld 582
Phone: +49 6221 4279010
Fax: +49 6221 4279042
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