Now Offering: Integration Site Analysis in the US

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Burlington Bio Center Lab Launches Integration Site Analysis Capabilities

December 13, 2022

For more than 20 years, GeneWerk, now part of ProtaGene, has pioneered advanced Integration Site Analysis (ISA), improving the safety of lentiviral and AAV gene therapies.

We’re excited to announce the addition of our industry-leading ISA methodologies to our new, state-of-the-art laboratory in the Burlington Bio Center, located in suburban Boston’s rapidly growing biotechnology hub.

Costly & Complex International Sample Shipping Eliminated

These new capabilities will eliminate the complex international shipping procedures and complicated customs requirements for sensitive materials. Our experts in Germany and the U.S. are now working together to meet the rapidly growing needs of gene therapy developers.

We tailor our ISA services to meet the needs of each of our clients, from receiving samples to report delivery, including sample QC, library preparation, next-generation sequencing, bioinformatics analysis, and reporting.

We contribute to safer gene therapies by ultimately delivering:

  • Data supporting safety assessments for cell and gene therapies involving viral vectors, non-viral vectors, or gene editing approaches
  • Superior assay performance in a wide range of viral vectors
  • De-risked regulatory approvals—the first ICH-validated ISA methodology
  • Fast turnaround times

Your Partner in Vector Integration Site Analysis

From project design and execution to data interpretation and regulatory approval, we provide agile, customer-focused solutions to support clients at every stage of the vector safety assessment process. Our Heidelberg and now Burlington sites are ready to ensure regulatory safety requirements are met for your gene therapy products.

Learn more about our Integration Site Analysis capabilities by downloading our Fact Sheet or contact us to discuss your project.