CASE STUDY #2: Commercializing Molecular Assay Kits?

A biotech startup was developing a PCR-based multiplex assays for detection in infectious and inherited diseases. These assays will run on an instrument platform that utilizes disposable cartridge containing a lyophilized PCR assay. The client approached us after they had completed development with our enzymes, which provided the performance that met their assay requirement. A major problem faced in lyophilized assay was that most enzymes on the market were incompatible with lyophilization due to presence of glycerol in the storage buffer.

Check out the video of Julia Fletcher, R&D Program Lead; discussing how we enter into a R&D and manufacturing development project with the client to remove glycerol from our enzymes prior to lyophilization. The project consisted of:

Development of a method in R&D to remove glycerol from the enzymes
Transfer of this method to manufacturing
Scaling and validation of the method in manufacturing

The collaboration with the client to co-develop and manufacture a custom product formulation allowed the client to bring their lyophilized assay to market. Download the “Take your assay anywhere” Case Study to learn more.