IN-HOUSE Laboratory Service
Bioassays play critical roles throughout the biological product lifecycle. With a QbD based scientific approach and clear understanding of regulatory expectations, development and implementation of qualified biological assays can generate a successful regulatory submission package, and therefore, significantly contribute to the quality and success of the program, and as well as save the overall development time and cost.
Cell Based Potency Assays
- Proliferation assays
- Assays to measure induction or inhibition of functionally essential protein or other signal molecule, such as phosphorylated proteins, enzymes, cytokines, and cyclic adenosine monophosphate (cAMP) are included under cell-based potency assays.
Mode Of Action Assays
- Cytotoxicity/apoptosis assays
- Reporter gene assays
- Enzyme-linked immunosorbent assay (ELISA)
- Surface Plasmon Resonance assay (SPR)
- Fluorescence-activated cell sorting (FACS)