Applications & Products / Bioassays for Biologics / Quality Control & Stability Testing
Contact a Specialist
Applications & Products

Bioassays for Potency & Stability Testing in Quality Control/Lot Release

High Reproducibility with a Simple Protocol for over 750 Targets

PathHunter® Bioassays are ideal for determining drug potency and stability using a simple and rapid, mix & read protocol that reflects the drug’s clinical mechanism of action.  These validated assays have been optimized for superior bioassay performance to enable a successful regulatory submission package, increasing quality and success of the program.   See How it Works
 




Assay Linearity of PathHunter Bioassays for Stability Testing

 
linearity of assay - GLP1R Bioassay
  

Key Features & Highlights

  • Over 1000 available assays
  • High reproducibility
  • Simple protocol with rapid results
  • Reflective of clinical MOA
  • Convenient and easy to transfer
 

Assay Availability
Linearity and range of the GLP1R PathHunter Bioassay was evaluated by testing with theoretical agonist activities ranging from 50% to 150%. The assay was linear over the range tested indicating suitability of the assay to indicate drug stability. 

Want to See Additional Data on Assay Reproducibility?

View slides: “Bioassays for Quality Control and Stability Testing During Biopharmaceutical Manufacturing” to see validation data.
 
View Validation Data  


Target-Specific and Robust Response

IGF1R Assay Specificity

       

GLP1R Time Course Assay
Adrenergic beta 2 receptor (ADRB2)   Prostaglandin D2 Receptor
Target Specific And Robust Assay PathHunter assays provide a target specific response to ligand. IGF1R assay (left panel) using the noted agonists and only observed a response with the IGF1 protein. PathHunter assays are extremely robust assays with a simple protocol. As noted in the GLP1R assay (right panel) at a variety of different time points and observed a robust, stable signal after 15 minutes.