Assay Development,
Qualification and Validation

Unique therapies

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.

The GeneWerk approach

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.

Want to get in touch?

Consult with our experts about solutions to your biosafety challenges.

Contact us

Latest news

Read our latest press releases and announcements below.

Protagen Protein Services merges with GeneWerk

Protagen Protein Services (PPS) today announced that it will merge with GeneWerk, an Ampersand...

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GeneWerk Announces Growth Equity Investment from Ampersand…

GeneWerk will expand capabilities to meet rapidly growing demand for cell and gene therapy...

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Insight into Spatial and Temporal Trends of…

Genewerk GmbH in collaboration with University Heidelberg Germany provided an insight into spatial and...

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GeneWerk in the Holiday Park

A little fun for everyone! This year’s company trip took us to the Holiday...

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