[2014 PEGS Conference] Validated Bioassays for Potency, Stability and Lot Release Testing of Biopharmaceuticals

[2014 PEGS Conference] Validated Bioassays for Potency, Stability and Lot Release Testing of Biopharmaceuticals
Version:
042814

File Name/Number:
2014 PEGS Conference

Year:
2014

Biologics represents one of the fastest growing classes of biopharmaceutical molecules today. One of the major bottlenecks in the development of biologics is the lack of ready-to-use bioassays for potency, stability and lot release testing.  Ideal bioassays need to reflect the clinical mechanism of action (MOA) of the biopharmaceutical drug and should be simple, accurate, precise, reproducible and robust according to proposed ICH guidelines.
We describe the validation and application of PathHunter® cell-based assays, a novel technology platform to create simple bioassays with rapid and reproducible results. This technology utilizes cells expressing full length receptors to pinpoint the underlying native biology of the receptor and drug, thereby reflecting the clinical MOA of the biopharmaceutical drug.  These assays are precise, scalable, robust and have a homogenous mix-and-read protocol, which facilitates accurate detection of drug potency. These target-specific assays have been developed for a majority of GPCRs, RTKs, Cytokine receptors and a variety of other receptors. Assays for GLP1R are presented as case studies, demonstrating the validation and application of these assays for potency, stability and lot-release testing of biopharmaceutical drugs.