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Applications & Products

Ready-to-Use Bioassays for Biosimilars & Biobetters

Simple, Rapid, Robust, and Reproducible Assays
 

Accelerate assay development for potency measurement and QC lot release testing with cell-based assays that use a simple, no-wash protocol to provide results in a few hours. Assays are available either as continuous culture cell lines or as bioassay kits. The bioassay kits increase the convenience and reproducibility of the assay by including cryopreserved ready-to-use cells. These assays have enabled multiple global clients to rapidly develop and successfully transfer precise, robust and accurate potency assays for use in QC lot release testing of their biosimilar drug.
 
 

 

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
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

These bioassays are currently in development and are also available as a custom assay development for customer-defined specifications. To request a custom bioassay for these biologics, email customdevelopment@eurofins.com.
INN Drug Name Molecular Mechanism of Action Assay Measures Cell Line
Canakinumab (IkB) Anti-IL-1b mAb IkB Degradation 93-0538C15
Canakinumab (IL1R/IL1RAP) Anti-IL-1b mAb IL1R/IL1RAP Dimerization 93-1032C3
Certolizumab pegol Anti-TNFa mAb IkB Degradation 93-0538C15
Cetuximab Anti-EGFR mAb Anti-EGFR mAb 93-1051C3
Denosumab Anti-RANKL mAb IkB Degradation 93-0994C3
Etanercept Anti-TNFa mAb IkB Degradation 93-0538C15
Follicle Stimulating Hormone FSHR agonist cAMP Accumulation 93-0517C2
Glucagon (cAMP) GCGR agonist cAMP Accumulation 95-0042C2
Glucagon (β-Arrestin) GCGR agonist β-Arrestin Recruitment 93-0241C2
Golimumab Anti-TNFa mAb IkB Degradation 93-0538C15
Growth-Hormone-Releasing Factor GHRHR agonist cAMP Accumulation 95-0076C2
Human Chorionic Gonadotropin (cAMP) LHCGR agonist cAMP Accumulation 95-0106C2
Human Chorionic Gonadotropin (β-Arrestin) LHCGR agonist β-Arrestin Recruitment 93-0957C2
Infliximab Anti-TNFa mAb IkB Degradation 93-0538C15
Lutropin (cAMP) LHCGR agonist cAMP Accumulation 95-0106C2
Lutropin (β-Arrestin) LHCGR agonist β-Arrestin Recruitment 93-0957C2
Rituximab anti-CD20 mAb ADCC 97-1012P026
Trastuzumab Anti-HER2 mAb ADCC In development