Developing an Inclusion and Safety Monitoring Assay for a Cell Therapy Clinical Trial
This cell therapy client was able to streamline clinical testing and accelerate the timeline of its phase 1/2 study by utilizing clinical trial support capabilities from Azenta.
A cell and gene therapy company needed a partner for clinical trial support. The immediate need was a quick turnaround time for development and validation of a biomarker assay using next generation sequencing (NGS). Azenta Life Sciences was able to develop a comprehensive, fit-for-purpose sample sourcing solution and assay, as well as logistics for distribution.
Learn how Azenta partnered with this client to achieve:
- Procurement of specific biospecimens to support the feasibility, development, and validation of the assay
- Custom, fit-for-purpose biomarker assay development
- Bioinformatics support
- CLIA/CAP validation and submission
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