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 using ICH (International Council for Harmonization) guidelines with marketed innovator biologic drugs or reference standards. These robust, quantitative, ready-to-use cell-based assays use a simple, homogeneous protocol. They are 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, 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 ICH guidelines
  • Robust & Reproducibility – High intra- & inter-lot reproducibility with assay linearity for stability & potency testing in QC lot release applications
  • Simple Protocol, Fast Results – Automation friendly, homogeneous protocol amenable to implementation in multiple labs & high-throughput format for increased efficiency

Consider Eurofins DiscoverX’s custom development capabilities for custom cell lines, assays, & enzyme development.

Products

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.

Qualified Bioassays

Bioassay Kit Drug Name Qualified With Molecular MOA Assay Measures
cAMP Hunter Tirzepatide (GIP RA) Bioassay Kit Tirzepatide Tirzepatide GIPR Agonist cAMP Accumulation
cAMP Hunter Tirzepatide (GLP-1 RA) Bioassay Kit Tirzepatide Tirzepatide GLP1R Agonist cAMP Accumulation
KILR® Raji ADCC Bioassay Kit Rituximab Direct Target Cell Death Antibody-Dependent Cellular-Cytotoxicity
cAMP Hunter Semaglutide Bioassay Kit Semaglutide Ozempic® GLP1R Agonist cAMP Accumulation
PathHunter® Aflibercept Bioassay Kits (includes HS version) Aflibercept Eylea® VEGF-Trap VEGFR2 (KDR) Dimerization
PathHunter® Bevacizumab Bioassay Bioassay Kits (includes HS version) Bevacizumab Avastin® Anti-VEGFA mAb VEGFR2 (KDR) Dimerization
PathHunter® Ranibizumab Bioassay Kits (includes HS version) Ranibizumab Lucentis® Anti-VEGFA mAb VEGFR2 (KDR) Dimerization
PathHunter® Adalimumab Bioassay Kit Adalimumab Humira® Anti-TNFα mAb IkB Degradation
PathHunter® PD-1 Bioassay Kit (SHP1 Signaling) Anti-PD-1/PD-L1 Keytruda® PD-L1-induced PD-1 Signaling SHP Recruitment
PathHunter® Tocilizumab Bioassay Kit Tocilizumab Actemra® Anti-ligand (IL-6) or Anti-receptor (IL-6RA) Drugs IL6RA/IL6ST Dimerization
PathHunter® Anakinra Bioassay Kit Anakinra Kineret® IL-1RA (Inhibits IL-1) IL1R/IL1RAP Dimerization
PathHunter® Darbepoetin Alfa Bioassay Kit Darbepoetin Alfa Aranesp® EPOR Agonist EpoR/EpoR Dimerization
PathHunter® Epoetin Alfa Bioassay Kit Epoetin Alfa Recombinant hEpo EPOR agonist EpoR/EpoR Dimerization
cAMP Hunter Exenatide Bioassay Kit Exenatide Byetta® GLP1R agonist cAMP Accumulation
cAMP Hunter Liraglutide Bioassay Kit Liraglutide Victoza® GLP1R agonist cAMP Accumulation
PathHunter® Insulin Glargine Bioassay Kit Insulin Glargine USP Insulin INSRb agonist SH2 Recruitment
PathHunter® Insulin Lispro Bioassay Kit Insulin Lispro USP Insulin INSRb agonist SH2 Recruitment
PathHunter® Insulin Bioassay Kit Insulin USP Insulin INSRb agonist SH2 Recruitment
PathHunter® Panitumumab Bioassay Kit Panitumumab ‎Vectibix® Anti-EGFR mAb EGFR/ErbB2 Dimerization
PathHunter® Pertuzumab Bioassay Kit Pertuzumab Perjeta® Anti-HER2-dimerization mAb ErbB2/ErbB3 Dimerization
cAMP Hunter Teriparatide Bioassay Kit Teriparatide ‎Forteo® PTHR agonist cAMP Accumulation
PathHunter® Growth Hormone Bioassay Kit Somatotropin, Somatropin Recombinant hGH GHR agonist SH2 Recruitment
cAMP Hunter Follitropin Alfa Bioassay Kit Follitropin alfa Gonal-F FSHR agonist cAMP Accumulation
PathHunter® Sargramostim Bioassay Kit Sargramostim Leukine® Recombinant GM-CSF (CSFR2 agonist) CSF2RB/CSF2R Dimerization
*HS Bioassay kits have been further optimized to deliver reproducible results with lower variability.

Target-based Bioassays

Bioassay Kit Target Molecular MOA Assay Measures
PathHunter® CALCRL-RAMP3 (AM2) Bioassay Kit AM2 CLR Agonist β-Arrestin Recruitment
cAMP Hunter GCGR Bioassay Kit GCG GCG Agonist cAMP Accumulation
cAMP Hunter GLP-1 RA Bioassay Kit GLP-1 GLP-1 Agonist cAMP Accumulation
cAMP Hunter GIP RA Bioassay Kit GIP GIP Agonist cAMP Accumulation
PathHunter® IL-15 Bioassay Kit (Dimerization) IL2RB/IL2RG IL-15 Agonist IL2Rβ/IL2Rγ Dimerization
PathHunter® IL-15 Bioassay Kit (Reporter) IL-15 Endogeneous Receptor Activation IL-15 Signaling
KILR® NCI-N87 ADCC Bioassay Kit HER2 Cytotoxicity Antibody-Dependent Cellular-Cytotoxicity (ADCC)
KILR® Raji ADCP Bioassay Kit CD19, CD20, CD38 Cytotoxicity Antibody-Dependent Cellular-Phagocytosis (ADCP)
KILR® Daudi ADCC Bioassay Kit CD19, CD20, CD38 Cytotoxicity Antibody-Dependent Cellular-Cytotoxicity (ADCC)
PathHunter® DLD1 IL7R/IL2RG Bioassay Kit IL7R/IL2RG IL-7 Agonists IL7R/IL2RG Dimerization
PathHunter® U2OS IL1RL1/IL1RAP Bioassay Kit IL1RL1/IL1RAP IL-33 Antagonists IL1RL1/IL1RAP Dimerization
PathHunter® U2OS TrkA-p75 Bioassay Kit TrkA-p75 Agonist drugs SH2 Recruitment
PathHunter® U2OS MCHR1 Bioassay Kit MCHR1 Agonist drugs β-Arrestin Recruitment
PathHunter® U2OS GHSR Bioassay Kit GHSR Agonist drugs β-Arrestin Recruitment
cAMP Hunter CHO-K1 LHCGR Bioassay Kit LHCGR Agonist drugs cAMP Accumulation
PathHunter® CHO-K1 MRGPRX2 Bioassay Kit MRGPRX2 Agonist drugs β-Arrestin Recruitment
PathHunter® CHO-K1 AGTR1 Bioassay Kit AGTR1 AGTR1 Agonists β-Arrestin Recruitment
PathHunter® CHO-K1 AGTRL1 Bioassay Kit AGTRL1 AGTRL1 Agonists β-Arrestin Recruitment
PathHunter® CHO-K1 BDKRB2 Bioassay Kit BDKRB2 BDKRB2 Agonists β-Arrestin Recruitment
PathHunter® CHO-K1 CNR1 Bioassay Kit CNR1 CNR1 Agonists β-Arrestin Recruitment
PathHunter® CHO-K1 C5AR1 Bioassay Kit C5AR1 Anti-ligand (anti-C5a) β-Arrestin Recruitment
PathHunter® CHO-K1 CCR2 Bioassay Kit CCR2 Antagonist drugs β-Arrestin Recruitment
PathHunter® CHO-K1 CXCR5 Bioassay Kit CXCR5 Antagonist drugs β-Arrestin Recruitment
PathHunter® Exendin-4 Bioassay Kit Exendin-4 Agonist drugs β-Arrestin Recruitment
PathHunter® U2OS FGFR4-β-Klotho Bioassay Kit FGFR4-β-Klotho Agonist drugs SH2 Recruitment
cAMP Hunter CHO-K1 GPBAR1 Bioassay Kit GPBAR1 Agonist drugs cAMP Accumulation
PathHunter® GLP1 (7-37) Bioassay Kit GLP1R Agonist drugs β-Arrestin Recruitment
PathHunter® CHO-K1 GLP2R Bioassay Kit GLP2R Agonist drugs β-Arrestin Recruitment
PathHunter® IGF-1 Bioassay Kit IGF1R Agonist drugs SH2 Recruitment
PathHunter® IL-2 Bioassay Kit (Dimerization) IL2RB/IL2RG/IL2RA Modified agonists; anti-IL2 drugs IL2RB/IL2RG/IL2RA Hetero-oligomerization
PathHunter® U2OS IL6RA/IL6ST Bioassay Kit IL6R/IL6ST Anti-IL-6 mAbs IL6RA/IL6ST Dimerization
PathHunter® U2OS IL10RA/IL10RB Dimerization Bioassay Kit IL10RA/IL10RB Anti-receptor (IL-10RA) drugs IL10RA/IL10RB Dimerization
PathHunter® IL-17A/IL-17F Bioassay Kit (Dimerization) IL17RA/IL17RC Anti-IL-17 mABs IL17RC/IL17RC Dimerization
PathHunter® U2OS IL31R/OSMRb Bioassay Kit IL31RA/OSMRb Anti-ligand (IL-31); Anti-receptor drugs IL31RA/OSMRb Dimerization
PathHunter® U2OS MC4R Bioassay Kit MC4R Antagonist drugs β-Arrestin Recruitment
PathHunter® CHO-K1 NPY2R Bioassay Kit NPY2R (β-Arrestin) Agonist, Antagonist drugs β-Arrestin Recruitment
cAMP Hunter CHO-K1 NPY2R Bioassay Kit NPY2R (cAMP) Agonist, Antagonist drugs cAMP Accumulation
PathHunter® U2OS PDGFRa Bioassay Kit PDGFRA Antagonist drugs SH2 Recruitment
PathHunter® U2OS PDGFRb Bioassay Kit PDGFRB Antagonist drugs SH2 Recruitment
PathHunter® PTH Bioassay Kit Parathyroid Hormone(PTH) Receptor Agonist drugs β-Arrestin Recruitment
PathHunter® Jurkat SIRPa Signaling Bioassay Kit SIRPa (-CD47) Agonists, Antagonist drugs SH2 Recruitment
PathHunter® CHO-K1 SSTR2 Bioassay Kit SSTR2 Agonist drugs β-Arrestin Recruitment
PathHunter® U2OS TrkB-P75 Bioassay Kit TrkB-p75 Antagonist drugs SH2 Recruitment
PathHunter® U2OS TrkC Bioassay Kit TrkC Antagonist drugs SH2 Recruitment
PathHunter® CHO-K1 VIPR2 Bioassay Kit VIPR2 Agonist drugs β-Arrestin Recruitment

Early Access Bioassays

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.

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