Our highly accomplished team of scientists and project managers enable our clients to safely deliver transformational gene therapies to the clinic. Dive deeper into our comprehensive services.
Leading the industry to safer gene therapies. Building on our two decades of expertise in gene therapy biosafety assessment, we support our clients from pre-clinical development to successful market authorization.
De-risk your development pathway. At GeneWerk, we ensure consistent regulatory compliance, right from preclinical development, through our comprehensive services for biosafety assessment.
Driven by patient safety. GeneWerk provides cell and gene therapy sponsors with patient testing services for biosafety assessment in compliance with FDA and EMA regulatory guidelines.
Customized assays tailored to your unique therapy. At GeneWerk, we offer flexible assay development, qualification and validation for in-house as well as customer-developed assays.
We help you gather actionable insights, not just generate data. GeneWerk’s customized bioinformatics pipelines enable data-driven decision-making to navigate the complex regulatory landscape.
Pioneering technologies implemented with precision. We offer the full range of biosafety analytical services to meet FDA safety standards for gene therapies – from sample preparation through to data interpretation and reporting.
Assess the potential insertional mutagenesis of your lentiviral and AAV vectors with utmost precision and sensitivity. Choose from GeneWerk’s best-in-class integration site analysis services.
This includes: S-EPTS/LM PCR, (nr)LAM-PCR, TES
Choose between PCR- and next-generation sequencing (NGS)-based solutions to accurately quantify on-target editing efficiency and off-target editing events at predicted loci, including chromosome translocation events.
This includes: PCR, NGS
Explore GeneWerk’s comprehensive cell and gene therapy product characterization services, including copy number estimation, nucleic acid impurities quantification, and replication competence testing.
This includes: AAVSEQ, LENTISEQ
Facilitate comprehensive immune-monitoring over time. Our best-in-class approaches allow simultaneous analysis of T cell receptor (all 4 chains) and B cell receptor immune repertoires.
This includes: TES-BASED, RACE-PCR
Quantify lentiviral vector copy numbers (VCN) with accuracy. Learn more about GeneWerk’s validated qPCR assay for absolute quantification of target copies.
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