Advantages of Bioassay
Bioassays are ideal for determining drug potency and stability using a simple, mix-&-read protocol that reflects the drug’s clinical mechanism of action. These rapid cell-based assays bypass the need for expensive and time-consuming cell culture, reducing lab work errors. Additionally, bioassays decrease assay development and validation times, provide accurate and precise data, reduce costs, facilitate a simplified global method transfer, and ultimately accelerate potency testing and QC lot release.
- Biologically-Relevant — MOA-reflective, functional assays for monitoring and testing of biologic therapeutics
- High Reproducibility — Superior intra-lot and inter-lot reproducibility and assay linearity for stability testing
- Robust Assays – Highly reproducible assays for potency and lot release applications for immunotherapy drug discovery and development
- Simple Protocol, Fast Results — Easy-to-run, rapid homogeneous protocol amenable to implementation in multiple labs and high-throughput format for increased efficiency
Features of Ready-to-Use Bioassay Kits for Biologics
- Assay design is based on the target biology
- Measure potency in single- or co-culture models to interrogate appropriate mechanisms of action
- Contains all components necessary for running the assay
- High inter- and intra-lot reproducibility (<10% CV)
- Simple protocol with results in 24 hours or less
- Seamless method transfer facilitates faster implementation at CMOs, CDMOs, or CROs
- Amenable to high throughput
Bioassay Kit Components
Each bioassay kit is sufficient for at least 1,000 data points and contains the following components:
- 10 vials of frozen ready-to-assay cells
- Detection Reagents
- Cell Plating Reagent
- Dilution Buffer
- Control Ligand
- 10 x 96-well Tissue Culture Treated Plates
Bioassay Programs
- Bioassay Certification – Provide your CRO/CDMO clients with the highest quality bioassays in the Industry. This program is designed to qualify CRO/CDMOs to run our bioassays so we can guide biopharma clients on which CRO/CDMOs they can use for their downstream therapeutic efforts. Learn More
- Analytical Cell Banks – Ensure long-term assay reproducibility with production of bioassay cells, which are considered as critical reagents, from dedicated, well-characterized, and established cell banks. Learn More
Key Resources
These qualified, off-the-shelf bioassays have been optimized for a particular drug and can reduce assay development timelines by at least 6 months. The simple, easy-to-use assay protocols deliver results fast, enabling implementation into QC lot release and transfer across sites globally.
| INN Drug Name |
Qualified With |
Molecular Mechanism of Action |
Assay Measures |
Qualification Data |
Bioassay Kits |
Configuration |
| Aflibercept |
Eylea® |
VEGF-Trap |
VEGFR2 (KDR) Dimerization |
Request Data |
New HS Version*
93-0996Y1-00153
93-0996Y1-00154 |
2-plate
10-plate |
Standard
93-0996Y1-00005
93-0996Y1-00006 |
2-plate
10-plate |
| Bevacizumab |
Lucentis® |
Anti-VEGDA mAb |
VEGFR2 (KDR) Dimerization |
Request Data |
New HS Version*
93-0996Y1-00165
93-0996Y1-00166 |
2-plate
10-plate |
Standard
93-0996Y1-00001
93-0996Y1-00002 |
2-plate
10-plate |
| Ranibizumab |
Avastin® |
Anti-VEGFA mAb |
VEGFR2 (KDR) Dimerization |
Request Data |
New HS Version*
93-0996Y1-00167
93-0996Y1-00168 |
2-plate
10-plate |
Standard
93-0996Y1-00003
93-0996Y1-00004 |
2-plate
10-plate |
| Adalimumab |
Humira® |
Anti-TNFα mAb |
IkB Degradation |
Request Data |
93-0538B15-00131 |
2-plate |
| 93-0538B15-00132 |
10-plate |
| Anti-PD-1/PD-L1 |
Keytruda® |
PD-L1-induced PD-1 signaling |
SHP Recruitment |
Request Data |
93-1104Y19-00117 |
2-plate |
| 93-1104Y19-00118 |
10-plate |
| Tocilizumab |
Actemra® |
Anti-ligand (IL-6) or anti-receptor (IL-6RA) drugs |
Ligand-induced receptor dimerization (IL6RA/IL6ST) |
Request Data |
93-1045B3-00109 |
2-plate |
| 93-1045B3-00110 |
10-plate |
| Anakinra |
Kineret® |
IL-1RA (Inhibits IL-1) |
IL1R/IL1RAP Dimerization |
Request Data |
93-1032Y3-00105 |
2-plate |
| 93-1032Y3-00106 |
10-plate |
| Darbepoetin Alfa |
Aranesp® |
EPOR agonist |
EpoR/EpoR Dimerization |
Request Data |
93-0965Y3-00019 |
2-plate |
| 93-0965Y3-00020 |
10-plate |
| Epoetin Alfa |
Recombinant hEpo |
EPOR agonist |
EpoR/EpoR Dimerization |
Request Data |
93-0965Y3-00017 |
2-plate |
| 93-0965Y3-00018 |
10-plate |
| Exenatide |
Byetta® |
GLP1R agonist |
cAMP Accumulation |
Request Data |
95-0062Y2-00101 |
2-plate |
| 95-0062Y2-00102 |
10-plate |
| Liraglutide |
Victoza® |
GLP1R agonist |
cAMP Accumulation |
Request Data |
95-0062Y2-00099 |
2-plate |
| 95-0062Y2-00100 |
10-plate |
| Insulin Glargine |
USP Insulin |
INSRb agonist |
SH2 Recruitment |
Request Data |
93-0466Y3-00011 |
2-plate |
| 93-0466Y3-00012 |
10-plate |
| Insulin Lispro |
USP Insulin |
INSRb agonist |
SH2 Recruitment |
Request Data |
93-0466Y3-00009 |
2-plate |
| 93-0466Y3-00010 |
10-plate |
| Insulin |
USP Insulin |
INSRb agonist |
SH2 Recruitment |
Request Data |
93-0466Y3-00007 |
2-plate |
| 93-0466Y3-00008 |
10-plate |
| Parathyroid Hormone (PTH) |
Recombinant hPTH |
PTHR agonist |
β-Arrestin Recruitment |
Request Data |
93-0315Y2-00047 |
2-plate |
| 93-0315Y2-00048 |
10-plate |
| Panitumumab |
Vectibix® |
Anti-EGFR mAb |
EGFR/ErbB2 Dimerization |
Request Data |
93-1051Y3-00093 |
2-plate |
| 93-1051Y3-00094 |
10-plate |
| Pertuzumab |
Perjeta® |
Anti-HER2-dimerization mAb |
ErbB2/ErbB3 Dimerization |
Request Data |
93-1042Y3-00095 |
2-plate |
| 93-1042Y3-00096 |
10-plate |
| Teriparatide |
Forteo® |
PTHR agonist |
cAMP Accumulation |
Request Data |
95-0118Y2-00057 |
2-plate |
| 95-0118Y2-00058 |
10-plate |
| Somatotropin, Somatropin |
Recombinant hGH |
GHR agonist |
SH2 Recruitment |
Request Data |
93-0756Y3-00023 |
2-plate |
| 93-0756Y3-00024 |
10-plate |
| Follitropin alfa |
Gonal-F |
FSHR agonist |
cAMP Accumulation |
Request Data |
95-0119Y2-00103 |
2-plate |
| 95-0119Y2-00104 |
10-plate |
| Sargramostim |
Leukine® |
Recombinant GM-CSF (CSFR2 agonist) |
CSF2RB/CSF2R Dimerization |
Request Data |
93-1078Y3-00111 |
2-plate |
| 93-1078Y3-00112 |
10-plate |
*HS Bioassay kits have been further optimized to deliver reproducible results with lower variability.
Ready-to-use target- or MOA-based bioassays are optimized with a reference ligand. These assays can be readily implemented in development programs for drug candidates (biologics or small molecules) that use the same mechanism of action or the target.
| Target |
Molecular Mechanism of Action |
Assay Measures |
Bioassay Kits |
Configuration |
| CD19, CD20, CD38 |
Cytotoxicity |
Antibody- Dependent Cellular-Cytotoxicity |
97-1012Y026-00169 |
2-plate |
| 97-1012Y026-00170 |
10-plate |
| IL7R/IL2RG |
IL-7R/IL-2RG Agonists |
Ligand-induced receptor (IL7R/IL2RG) Dimerization |
93-0997Y13-00081 |
2-plate |
| 93-0997Y13-00082 |
10-plate |
| IL1RL1/IL1RAP |
IL-1RL1/IL1RAP Antagonists |
Ligand-induced receptor (IL1RL1/IL1RAP) Dimerization |
93-1067Y3-00079 |
2-plate |
| 93-1067Y3-00080 |
10-plate |
| TrkA-p75 |
Agonist drugs |
SH2 Recruitment |
93-0529Y3-00147 |
2-plate |
| 93-0529Y3-00148 |
10-plate |
| MCHR1 |
Agonist drugs |
β-Arrestin Recruitment |
93-0940Y3-00149 |
2-plate |
| 93-0940Y3-00150 |
10-plate |
| GHSR |
Agonist drugs |
β-Arrestin Recruitment |
93-0242Y3-00141 |
2-plate |
| 93-0242Y3-00142 |
10-plate |
| LHCGR |
Agonist drugs |
cAMP Accumulation |
95-0106Y2-00137 |
2-plate |
| 95-0106Y2-00138 |
10-plate |
| MRGPRX2 |
Agonist drugs |
β-Arrestin Recruitment |
93-0309Y2-00143 |
2-plate |
| 93-0309Y2-00144 |
10-plate |
| AGTR1 |
AGTR1 Agonists |
β-Arrestin Recruitment |
93-0312Y2-00125 |
2-plate |
| 93-0312Y2-00126 |
10-plate |
| AGTRL1 |
AGTRL1 Agonists |
β-Arrestin Recruitment |
93-0250Y2-00121 |
2-plate |
| 93-0250Y2-00122 |
10-plate |
| BDKRB2 |
BDKRB2 Agonists |
β-Arrestin Recruitment |
93-0189Y2-00113 |
2-plate |
| 93-0189Y2-00114 |
10-plate |
| CNR1 |
CNR1 Agonists |
β-Arrestin Recruitment |
93-0959Y2-00119 |
2-plate |
| 93-0959Y2-00120 |
10-plate |
| C5AR1 |
anti-ligand (anti-C5a) |
β-Arrestin Recruitment |
93-0557Y2-00059 |
2-plate |
| 93-0557Y2-00060 |
10-plate |
| CCR2 |
antagonist drugs |
β-Arrestin Recruitment |
93-0192Y2-00061 |
2-plate |
| 93-0192Y2-00062 |
10-plate |
| CXCR5 |
antagonist drugs |
β-Arrestin Recruitment |
93-0514Y2-00063 |
2-plate |
| 93-0514Y2-00064 |
10-plate |
| Exendin-4 |
agonist drugs |
β-Arrestin Recruitment |
93-0300Y2-00029 |
2-plate |
| 93-0300Y2-00030 |
10-plate |
| FGFR4-β-Klotho |
agonist drugs |
SH2 Recruitment |
93-1060Y3-00089 |
2-plate |
| 93-1060Y3-00090 |
10-plate |
| GPBAR1 |
agonist drugs |
cAMP Accumulation |
95-0049Y2-00139 |
2-plate |
| 95-0049Y2-00140 |
10-plate |
| GLP1R |
agonist drugs |
β-Arrestin Recruitment |
93-0300Y2-00027 |
2-plate |
| 93-0300Y2-00028 |
10-plate |
| GLP2R |
agonist drugs |
β-Arrestin Recruitment |
93-0572Y2-00133 |
2-plate |
| 93-0572Y2-00134 |
10-plate |
| IGF1R |
agonist drugs |
SH2 Recruitment |
93-0505Y1-00069 |
2-plate |
| 93-0505Y1-00070 |
10-plate |
| IL2RB/IL2RG/IL2RA |
modified agonists; anti-IL2 drugs |
Ligand-Induced Receptor (IL2RB/IL2RG/IL2RA) Hetero-oligomerization |
93-1003Y3-00091 |
2-plate |
| 93-1003Y3-00092 |
10-plate |
| IL6R/IL6ST |
Anti-IL-6 mAbs |
Ligand-induced receptor (IL6RA/IL6ST) dimerization |
93-1045Y3-00043 |
2-plate |
| 93-1045Y3-00044 |
10-plate |
| IL10RA/IL10RB |
anti-receptor (IL-10RA) drugs |
Ligand-induced receptor dimerization (IL10RA/IL10RB) |
93-0985Y3-00135 |
2-plate |
| 93-0985Y3-00136 |
10-plate |
| IL17RA/IL17RC |
Anti-IL-17 mABs |
Ligand-induced receptor (IL17RC/IL17RC) Dimerization |
93-0999Y3-00053 |
2-plate |
| 93-0999Y3-00054 |
10-plate |
| IL31RA/OSMRb |
anti-ligand (IL-31); anti-receptor drugs |
Ligand-induced receptor (IL31RA/OSMRb) dimerization |
93-1002Y3-00083 |
2-plate |
| 93-1002Y3-00084 |
10-plate |
| MC4R |
antagonist drugs |
β-Arrestin Recruitment |
93-0211Y3-00085 |
2-plate |
| 93-0211Y3-00086 |
10-plate |
| NPY2R (β-Arrestin) |
agonist, antagonist drugs |
β-Arrestin Recruitment |
93-0212Y2-00065 |
2-plate |
| 93-0212Y2-00066 |
10-plate |
| NPY2R (cAMP) |
agonist, antagonist drugs |
cAMP Accumulation |
95-0077Y2-00055 |
2-plate |
| 95-0077Y2-00056 |
10-plate |
| PD-1 |
Anti-PD-1, PD-L1 drugs |
SHP Recruitment |
93-1104Y19-00117 |
2-plate |
| 93-1104Y19-00118 |
10-plate |
| PDGFRA |
antagonist drugs |
SH2 Recruitment |
93-0823Y3-00071 |
2-plate |
| 93-0823Y3-00072 |
10-plate |
| PDGFRB |
antagonist drugs |
SH2 Recruitment |
93-0493Y3-00073 |
2-plate |
| 93-0493Y3-00074 |
10-plate |
| SIRPa (-CD47) |
agonists, antagonist drugs |
SH2 Recruitment |
93-1135Y19-00129 |
2-plate |
| 93-1135Y19-00130 |
10-plate |
| SSTR2 |
agonist drugs |
β-Arrestin Recruitment |
93-0181Y2-00067 |
2-plate |
| 93-0181Y2-00068 |
10-plate |
| TrkB-p75 |
antagonist drugs |
SH2 Recruitment |
93-0530Y3-00075 |
2-plate |
| 93-0530Y3-00076 |
10-plate |
| TrkC |
antagonist drugs |
SH2 Recruitment |
93-0464Y3-00077 |
2-plate |
| 93-0464Y3-00078 |
10-plate |
| VIPR2 |
agonist drugs |
β-Arrestin Recruitment |
93-0317Y2-00087 |
2-plate |
| 93-0317Y2-00088 |
10-plate |
Applications of EFC for Biologics Development
DiscoverX has exploited the versatile features of Enzyme Fragment Complementation (EFC) technology to create bioassay for a vast number of proteins and applications
EFC technology can be used to study multiple cell surface receptors and their ligands. By exploiting the natural biology of various receptors, this technology can be used to create simple, cell-based chemiluminescent assays. A. By tagging the receptor and the activation-based intracellular response protein, measure receptor activation, e.g. β-arrestin recruitment to an activated GPCR. B. By tagging the early endosome and the receptor, follow receptor internalization for GPCRs, RTKs, and other receptors. C. By tagging various receptors, monitor the formation of receptor heterodimers and homodimers. D. By tagging cellular pathway proteins, evaluate signaling events downstream of receptor activation including cAMP accumulation, protein translocation, or protein degradation.
Potency & Stability Testing in QC Lot Release
Eurofins DiscoverX’s high reproducibility 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 qualified assays have been optimized for superior bioassay performance to enable a successful regulatory submission package, increasing quality and success of the program.
Excellent Assay Reproducibility and Linearity
Bioassays show excellent accuracy and precision. A. PathHunter CHO-K1 CNR1 Bioassay dose response curves for CP 55,940 (a synthetic cannabinoid) demonstrating β-arrestin recruitment in a dose-dependent manner for three days. Table summarizing EC50 values and %RSD for each day; and mean EC50 and %RSD across three days. All three curves show a high degree of overlap for every experiment, thereby demonstrating superior intra-day reproducibility and precision. B. and C. PathHunter Jurkat PD-1 Signaling Bioassay linearity plots showing the average measured relative potency plotted against the expected relative potency for Keytruda and Opdivo, respectively. These assay linearity graphs quantify data generated by two analysts using this bioassay over four days. D. The PD-1 signaling bioassay demonstrates excellent accuracy, precision, and linearity for both Keytruda and Opdivo. Precision values are expressed as a percentage of Relative Standard Deviation (RSD).
Highly Specific Responses for MOA-Reflective Bioassays
Bioassay measures highly target-specific response to ligands. A. PathHunter Anakinra Bioassay cells expressing the IL-1 receptor (assay quantifies ligand-induced heterodimerization of the IL-1RA and IL-1RAP subunits that comprise the receptor) were treated with various ligands that mediate signaling through the NF-kB pathway, which acts downstream of multiple IL-1 family receptors. Only IL-1β induces a signal in the assay, reflecting the specificity of the assay for IL-1β. B. Two different drugs, Anakinra (which blocks signaling through the IL-1R by blocking IL-1β-mediated dimerization and signaling) and Adalimumab (which binds TNFα, and prevents signaling through the TNFR) were tested in the IL-1R/IL-1RAP bioassay. Only Anakinra blocks IL-1β-mediated dimerization.