Bioassays are critical for elucidating and confirming drug MOA during discovery, and measuring drug potency and stability during the later phases of drug development and manufacturing.
Critical attributes of functional bioassays are defined in ICH and USP guidelines and include specificity, accuracy, precision, linearity, range and robustness. To facilitate the development and implementation of functional bioassays in your laboratory, we offer:
- Reporter bioassays developed and prequalified in accordance with ICH Q6B, USP Chapter 1032 guidelines.
- A portfolio of cell viability assays with demonstrated use for biologics characterization and validation for QC lot release.
- Bioassay qualification services to facilitate downstream validation studies in your laboratory or with a CRO partner.