Bioassays for Biologics
Ready-to-Use, Cell-based Assays for Biologics Therapeutic Development Including Characterization, MOA Confirmation, nAbs Detection, Stability Studies, and Potency Testing
Bioassays are analytical methods used to measure a drug's biological activity or potency using a biological system representing the mechanism of action (MOA) of that drug.
Eurofins DiscoverX® offers an extensive portfolio of cell-based, mechanistically-relevant bioassays, optimized and qualified with marketed biologic drugs or reference standards using ICH (International Council for Harmonization) guidelines. These robust, quantitative, ready-to-use cell-based assays use a simple, homogenous protocol.
They can be easily implemented for characterization, potency measurement, neutralizing antibodies (nAb) detection, stability studies, and many other additional applications to interrogate biological functions and accelerate your biologics development program from discovery to post-market QC lot-release testing.
Bioassays are ideal for determining drug potency and stability using a simple, homogeneous protocol that reflects the drug’s clinical MOA. These rapid cell-based assays bypass the need for expensive and time-consuming cell culturing or assay development, thereby potentially reducing timelines and errors.
Product Highlights
- Biologically Relevant – MOA-reflective, functional assays for monitoring and testing of biologic therapeutics
- Qualified – Qualified with marketed biologic drugs or reference standards using International Council for Harmonization (ICH) guidelines
- Robust & High Reproducibility – Superior intra-lot and inter-lot reproducibility and assay linearity for stability and potency testing and QC lot release applications
- Simple Protocol, Fast Results – Easy-to-run, rapid homogeneous protocol amenable to implementation in multiple labs and high-throughput format for increased efficiency
Bioassays are ready-to-use cell-based assay kits with a simple, homogenous protocol and are provided as qualified or target-based. These bioassay kits deliver results in less than a day, enabling implementation in QC lot-release programs and transfer across multiple testing sites globally. Qualified bioassays have been optimized for their respective originator drug or reference standard, and can easily reduce assay development timelines by over 12 months. Ready-to-use target-based or MOA-based bioassays are optimized with a reference ligand. These assays can be readily implemented in development programs for biologic drug candidates that use the same MOA or specific target and can be further optimized and qualified with the clinical drug candidate.
Drug Name | Qualified With | Molecular MOA | Assay Measures | Qualification Data | Bioassay Kits & Configuration |
---|---|---|---|---|---|
Rituximab | – | Cytotoxicity | Antibody-Dependent Cellular-Cytotoxicity | View Data | 97-1012Y026-00169 (2-plate) 97-1012Y026-00170 (10-plate) |
Semaglutide | Ozempic® | GLP1R agonist | cAMP Accumulation | View Data | 95-0062Y2-00175 (2-plate) 95-0062Y2-00176 (10-plate) |
Aflibercept | Eylea® | VEGF-Trap | VEGFR2 (KDR) Dimerization | View Data | New HS Version* 93-0996Y1-00153 (2-plate) 93-0996Y1-00154 (10-plate) Standard 93-0996Y1-00005 (2-plate) 93-0996Y1-00006 (10-plate) |
Bevacizumab | Avastin® | Anti-VEGFA mAb | VEGFR2 (KDR) Dimerization | View Data | New HS Version* 93-0996Y1-00165 (2-plate) 93-0996Y1-00166 (10-plate) Standard 93-0996Y1-00001 (2-plate) 93-0996Y1-00002 (10-plate) |
Ranibizumab | Lucentis® | Anti-VEGFA mAb | VEGFR2 (KDR) Dimerization | View Data | New HS Version* 93-0996Y1-00167 (2-plate) 93-0996Y1-00168 (10-plate) Standard 93-0996Y1-00003 (2-plate) 93-0996Y1-00004 (10-plate) |
Adalimumab | Humira® | Anti-TNFα mAb | IkB Degradation | View 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 | View 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) | View Data | 93-1045B3-00109 (2-plate) 93-1045B3-00110 (10-plate) |
Anakinra | Kineret® | IL-1RA (Inhibits IL-1) | IL1R/IL1RAP Dimerization | View Data | 93-1032Y3-00105 (2-plate) 93-1032Y3-00106 (10-plate) |
Darbepoetin Alfa | Aranesp® | EPOR agonist | EpoR/EpoR Dimerization | View Data | 93-0965Y3-00019 (2-plate) 93-0965Y3-00020 (10-plate) |
Epoetin Alfa | Recombinant hEpo | EPOR agonist | EpoR/EpoR Dimerization | View Data | 93-0965Y3-00017 (2-plate) 93-0965Y3-00018 (10-plate) |
Exenatide | Byetta® | GLP1R agonist | cAMP Accumulation | View Data | 95-0062Y2-00101 (2-plate) 95-0062Y2-00102 (10-plate) |
Liraglutide | Victoza® | GLP1R agonist | cAMP Accumulation | View Data | 95-0062Y2-00099 (2-plate) 95-0062Y2-00100 (10-plate) |
Insulin Glargine | USP Insulin | INSRb agonist | SH2 Recruitment | View Data | 93-0466Y3-00011 (2-plate) 93-0466Y3-00012 (10-plate) |
Insulin Lispro | USP Insulin | INSRb agonist | SH2 Recruitment | View Data | 93-0466Y3-00009 (2-plate) 93-0466Y3-00010 (10-plate) |
Insulin | USP Insulin | INSRb agonist | SH2 Recruitment | View Data | 93-0466Y3-00007 (2-plate) 93-0466Y3-00008 (10-plate) |
Panitumumab | Vectibix® | Anti-EGFR mAb | EGFR/ErbB2 Dimerization | View Data | 93-1051Y3-00093 (2-plate) 93-1051Y3-00094 (10-plate) |
Pertuzumab | Perjeta® | Anti-HER2-dimerization mAb | ErbB2/ErbB3 Dimerization | View Data | 93-1042Y3-00095 (2-plate) 93-1042Y3-00096 (10-plate) |
Teriparatide | Forteo® | PTHR agonist | cAMP Accumulation | View Data | 95-0118Y2-00057 (2-plate) 95-0118Y2-00058 (10-plate) |
Somatotropin, Somatropin | Recombinant hGH | GHR agonist | SH2 Recruitment | View Data | 93-0756Y3-00023 (2-plate) 93-0756Y3-00024 (10-plate) |
Follitropin alfa | Gonal-F | FSHR agonist | cAMP Accumulation | View Data | 95-0119Y2-00103 (2-plate) 95-0119Y2-00104 (10-plate) |
Sargramostim | Leukine® | Recombinant GM-CSF (CSFR2 agonist) | CSF2RB/CSF2R Dimerization | View Data | 93-1078Y3-00111 (2-plate) 93-1078Y3-00112 (10-plate) |
Target | Molecular MOA | Assay Measures | Bioassay Kits & Configuration |
---|---|---|---|
IL2RB/IL2RG | IL-15 Agonist | Ligand induced receptor (IL2Rβ/IL2Rγ) dimerization | 93-0998Y3-00183 (2-plate) 93-0998Y3-00184 (10-plate) 93-0998Y3-00188 (10-plate, no ligand) |
HER2 | Cytotoxicity | Antibody-Dependent Cellular-Cytotoxicity | 97-1004Y021-00173 (2-plate) 97-1004Y021-00174 (10-plate) |
CD19, CD20, CD38 | Cytotoxicity | Antibody-Dependent Cellular-Phagocytosis | 97-1012Y026-00179 (2-plate) 97-1012Y026-00180 (10-plate) 97-1009Y025-00177 (2-plate) 97-1009Y025-00178 (10-plate) |
CD19, CD20, CD38 | Cytotoxicity | Antibody-Dependent Cellular-Cytotoxicity | 97-1012Y026-00169 (2-plate) 97-1012Y026-00170 (10-plate) 97-1009Y025-00171 (2-plate) 97-1009Y025-00172 (10-plate) |
IL7R/IL2RG | IL-7 Agonists | Ligand-induced receptor (IL7R/IL2RG) Dimerization | 93-0997Y13-00081 (2-plate) 93-0997Y13-00082 (10-plate) |
IL1RL1/IL1RAP | IL-1 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) 93-1003Y3-00187 (10L-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) |
Parathyroid Hormone(PTH) Receptor | Agonist drugs | β-Arrestin Recruitment | 93-0315Y2-00047 (2-plate) 93-0315Y2-00048 (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) |
Eurofins DiscoverX helps accelerate the entry of your therapeutic molecule to market for the latest and most researched targets with a list of early access cell based potency assays/ bioassays. The early access program offers cell-based potency assays as bioassays available with a short lead-time of 6-8 weeks. These bioassays are ideal for potency testing and detection of neutralizing antibodies. Each bioassay kit is available in 2- or 10-plate bioassay configurations and contains all the materials needed to perform a complete assay, including ready-to-use cryopreserved single-use cells, detection reagents, cell plating reagent, agonist for stimulating the cells, assay plates, and user manual and certificate of analysis.
Early Access Bioassay Kits
Drug Name or Target | Molecular Moa | Assay Measures | Cat. No. |
---|---|---|---|
Denosumab | Anti-RANKL mAb | NF-κB transcriptional reporter | Inquire |
CXCR2 | Agonist drugs | β-Arrestin recruitment | Inquire |
CALCRL-RAMP3 | Agonist drugs | β-Arrestin recruitment | Inquire |
MC1R | Agonist drugs | β-Arrestin recruitment | Inquire |
CSF1R/CSF1R | Antagonist drugs | Ligand-mediated Receptor Dimerization | Inquire |
AXL | Agonist drugs | SH2 recruitment | Inquire |
Advantages of Assay Ready Kits
Bioassays are ideal for determining drug potency and stability using a simple, homogeneous protocol that reflects the drug’s clinical MOA. These rapid cell-based assays bypass the need for expensive and time-consuming cell culturing or assay development, thereby potentially reducing timelines and errors.
Benefits | Outcomes | Implementation |
---|---|---|
Decrease assay development and validation times | Obtain biologically relevant data with assays reflective of the target biology | Simple, homogenous protocol that yields results in < 24 hours |
Provide accurate and precise data | Measure therapeutic potency | Seamless method transfer for faster implementation at CMOs, CDMOs, or CROs |
Reduce costs | Interrogate appropriate MOA | Amenable to miniaturization to run in high-throughput 384 well format |
Accelerate potency testing and QC lot release | Attain high lot-to-lot reproducibility |

A quantitative and robust bioassay that is reflective of the drugs’ MOA is a critical component of any development program. Eurofins DiscoverX offers bioassays that can be implemented to accelerate your biologics development program from discovery to post-market. For characterization and QC lot-release testing, where assay reproducibility is paramount, ready-to-use (RTU) bioassays help you save over 12 months of assay development time.

A well-structured process for bioassay development yields assays that are robust and reproducible. The process begins with selecting the assay that most appropriately reflects the MOA of the drug, followed by optimization of assay parameters. Optimization through qualification steps includes refining conditions with the originator drug or reference molecule to establish robustness, precision, accuracy, and linearity of assay.
Highlights of Bioassays
Reflective of MOA of the therapeutic or molecule | Repeatable, robust, precise, and accurate | Intra-lot (plate-to-plate) |
Stability-indicating | Reproducible | Inter-lot (lot-to-lot) |
Relative potency range (50 to 150%) | Analyst-to-analyst |
Our dedicated team of Field Application Scientists ensures seamless and successful bioassay method transfer across all testing sites. Our analytical cell banking program is available to ensure long-term assay reproducibility and critical reagent supply assurance.
Bioassays measure highly target-specific response and enable interrogation of the therapeutic drug’s MOA.



Eurofins DiscoverX utilizes the robust and flexible Enzyme Fragment Complementation (EFC) technology to design bioassays for interrogating specific MOA that reflect the therapeutic target’s biology. Select examples are shown below of the bioassays’ design to interrogate different MOAs.
Potency Testing
During the late stages of drug development, potency testing is an integral part for the assessment of a drug’s specific ability to produce a given result. Bioassays are the primary tool used for measuring drug efficacy during potency testing, enabling researchers to determine how a particular drug dose will react in a given biological system. Bioassays are also critical bioanalytical tools that enable the determination drug’s MOA. Cell-based assays help establish the relative potency of a product by comparing the biological activity of a drug’s MOA with a reference preparation (from the USP, WHO, or in-house reference standard).

Potency testing of Eurofins DiscoverX bioassays. The PathHunter® Jurkat PD-1 Bioassay Kit was used to test for accuracy, precision, and dilutional linearity. A. Anti-PD-1 samples were tested at varying potencies (ranging from 50% to 150%) relative to a reference sample of 100% potency. The experiments were performed in triplicates in three independent experiments by two analysts over three days. RP = relative potency. Results demonstrate that the assay was found to be extremely accurate (101.2%) and precise (3.1%). B. To demonstrate dilutional linearity of anti-PD-1 sample measurements, we analyzed “measured” against “expected” relative potencies and calculated the slope of the curve and the associated R2 values, arriving at an almost perfect R2 value of 99.4%.
Stability Testing

Stability testing of Eurofins DiscoverX bioassays. A. Heat-stressed samples of an anti-PD-1 antibody were tested to evaluate if the PathHunter PD-1 Signaling Bioassay will differentiate the stressed material from the reference sample. A marked difference between the two response curves of the heat stress and reference samples was observed. B. To demonstrate that the PathHunter PD-1 Signaling Bioassay is stability-indicating, an additional set of experiments were performed as a part of a qualification study at BioOutsource with Nivolumab. The results indicate that only the heat-treated sample showed significant reduction activity, while the freeze thawed sample displayed no differences with respect to the untreated reference material. To further confirm these results, the heat-treated samples were run at 143% Relative Potency to assess the sensitivity to the assay when run at a different potency interval. At 143%, the results returned with a similar shift in the potency of the heat-treated sample as at 100%.
Neutralizing Anti-Drug Antibody Detection
Eurofins DiscoverX bioassays are widely used to detect neutralizing anti-drug antibodies (ADAs) or neutralizing antibodies (NAbs) in patient serum samples (e.g., up to 100% human serum), with high sensitivity and reproducibility.

Example of detection of ADAs activity in the PathHunter Bevacizumab Bioassay Kit. Samples prepared in 10% pooled normal human serum. Increasing concentrations of NAbs against bevacizumab returns assay signal to levels comparable to VEGF alone. Further, the assay is sensitive enough to detect >100 ng of NAb when prepared in 10% human serum. FDA guidelines specify minimum sensitivity of 1000 ng/mL for detection of NAb in human serum.
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Cell-based assays to measure 2nd messengers (cAMP & calcium), β-arrestin recruitment, receptor internalization, & ligand binding
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Enzymes & cell-based functional, binding, & activity assays for discovery through development & for QC lot-release testing
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Custom cell lines, kits, assays, & protein development capabilities optimized to fit your requirements
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