Unique therapies often warrant customized assays to adequately assess their safety. GeneWerk’s flexible assay development, qualification and validation services are not limited to our in-house developed assays.
We help develop, qualify and validate new or partially-developed assays for customers with unique requirements.
We work closely with our clients often acting as an extension of their internal technical teams. From customization of proven assays to new biomarker assay development, we provide best-in-class services to address specific regulatory needs for emerging gene therapies.
Our highly experienced and interdisciplinary team has been developing and validating assays for over two decades to tackle complex safety issues such as the investigation of severe adverse events (SAEs) during clinical development.
Read our latest press releases and announcements below.
GeneWerk will expand capabilities to meet rapidly growing demand for cell and gene therapy...