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Ready-to-go Bioassays for >35 Biosimilars & Biobetters

Simple, Rapid, Robust, and Reproducible Bioassays

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.
 
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Available Bioassays for Biosimilars

Download assay verification data for each assay below.
Biosimilar or Biobetter Drug INN Drug Name Molecular Mechanism of Action Verification Data Bioassay Kits Kit Size Cell Line
Darbepoetin Alfa Darbepoetin Alfa EPOR agonist View data 93-0965Y3-00019 2-plate 93-0965C3
93-0965Y3-00020 10-plate
Epoetin Alfa Epoetin Alfa EPOR agonist View data 93-0965Y3-00017 2-plate 93-0965C3
93-0965Y3-00018 10-plate
Growth Hormone Somatotropin, Somatropin GHR agonist View data 93-0756Y3-00023 2-plate 93-0756C3
93-0756Y3-00024 10-plate
Exendin-4 Exenatide, Lixisenatide GLP1R agonist (β-Arrestin) Request Data 93-0300Y2-00029 2-plate 93-0300C2
93-0300Y2-00030 10-plate
Exendin-4 Exenatide, Lixisenatide GLP1R agonist (cAMP) Request Data 95-0062Y2-00101 2-plate 95-0062C2
95-0062Y2-00102 10-plate
GLP1 (7-37) Liraglutide, Albiglutide, Dulaglutide GLP1R agonist (β-Arrestin) Request Data 93-0300Y2-00027 2-plate 93-0300C2
93-0300Y2-00028 10-plate
GLP1 (7-37) Liraglutide, Albiglutide, Dulaglutide GLP1R agonist (cAMP) Request Data 95-0062Y2-00099 2-plate 95-0062C2
95-0062Y2-00100 10-plate
Ustekinumab Ustekinumab Anti-p40 mAb (Inhibits IL-12 & IL-23)   NA   93-1007C3
   
Tocilizumab Tocilizumab, atlizumab Anti-IL6R mAb Request Data 93-1045Y3-00043 2-plate 93-1045C3
93-1045Y3-00044 10-plate
Insulin Glargine Insulin Glargine INSRb agonist View data 93-0466Y3-00011 2-plate 93-0466C3
93-0466Y3-00012 10-plate
Insulin Lispro Insulin Lispro INSRb agonist View data 93-0466Y3-00009 2-plate 93-0466C3
93-0466Y3-00010 10-plate
Insulin Insulin, Insulin Aspart INSRb agonist View data 93-0466Y3-00007 2-plate 93-0466C3
93-0466Y3-00008 10-plate
Parathyroid Hormone (PTH) Teriparatide, PTH PTHR agonist (β-Arrestin) Request Data 93-0315Y2-00047 2-plate 93-0315C2
93-0315Y2-00048 10-plate
Aflibercept Aflibercept, ziv-aflibercept Anti-VEGFA Receptor View data 93-0996Y1-00005 2-plate 93-0996C1
93-0996Y1-00006 10-plate
Ranibizumab Ranibizumab Anti-VEGFA mAb View data 93-0996Y1-00003 2-plate 93-0996C1
93-0996Y1-00004 10-plate
Bevacizumab Bevacizumab Anti-VEGFA mAb View data 93-0996Y1-00001 2-plate 93-0996C1
93-0996Y1-00002 10-plate
Secukinumab Secukinumab Anti-IL17A mAb Request Data 93-0999Y3-00053 2-plate 93-0999C3
93-0999Y3-00054 10-plate
Rituximab Rituximab, IDEC-C2B8, Ofatumumab CD20 (ADCC) Request Data NA   In development
Cetuximab Cetuximab Anti-EGFR mAb Request Data NA   93-1051C3
Panitumumab Panitumumab Anti-EGFR mAb Request Data 93-1051Y3-00093
93-1051Y3-00094		 2-plate
10-plate		 93-1051C3
Pertuzumab 2C4, Pertuzumab Anti-HER2-dimerization mAb Request Data 93-1042Y3-00095
93-1042Y3-00096		 2-plate
10-plate		 93-1042C3
Teriparatide Teriparatide, PTH PTHR agonist (cAMP) Request Data 95-0118Y2-00057
95-0118Y2-00058		 2-plate
10-plate		 95-0118C2
Trastuzumab Trastuzumab Anti-HER2 mAb Request Data NA   In development
Follicle Stimulating Hormone (FSH) Follitropin alfa, FSH FSHR agonist (cAMP) Request Data *   95-0119C2
Follicle Stimulating Hormone (FSH) Follitropin alfa, FSH FSHR agonist (β-Arrestin) Request Data NA   93-0517C2
Glucagon Glucagon GCGR agonist (cAMP) Request Data NA   95-0042C2
Glucagon Glucagon GCGR agonist (β-Arrestin) Request Data *   93-0241C2
GHRH Growth-hormone-releasing factor, somatorelin GHRHR agonist (cAMP) Request Data *   95-0076C2
Denosumab Denosumab Anti-RANKL mAb Request Data NA   93-0994C3
Infliximab Infliximab Anti-TNFa mAb Request Data NA   93-0538C15
Golimumab Golimumab Anti-TNFa mAb Request Data NA   93-0538C15
Etanercept Etanercept Anti-TNFa mAb Request Data NA   93-0538C15
Certolizumab pegol Certolizumab pegol Anti-TNFa mAb Request Data NA   93-0538C15
Adalimumab Adalimumab Anti-TNFa mAb Request Data NA   93-0538C15
Anakinra Anakinra IL-1RA (Inhibits IL-1) Request Data *   93-0538C15
Canakinumab Canakinumab, ACZ885 Anti-IL-1b mAb Request Data *   93-0538C15
Lutenizing Hormone (LH) Lutropin, lutrophin LHCGR agonist (cAMP) Request Data *   95-0106C2
Human Chorionic Gonadotropin (hCG) hCG LHCGR agonist (cAMP) Request Data *   95-0106C2
Lutenizing Hormone (LH) Lutropin, lutrophin LHCGR agonist (β-Arrestin) Request Data NA   93-0957C2
Human Chorionic Gonadotropin (hCG) hCG LHCGR agonist (β-Arrestin) Request Data NA   93-0957C2
*  Bioassay kits are currently under development. To develop a potency assay immediately, please use the continuous culture cell lines that are noted above for these targets.

NA – These bioassay kits are not available and are not being developed. Please use the continuous culture cell lines noted above or request custom development of these kits.
 

Key Features and Benefits
  • Verified - Tested with innovator drug or drug-like molecule
  • MOA-based - Reliant on native biology
  • Simple - Easy mix-&-read protocol
  
  • Rapid - Results in a few hours from treatment of cells
  • QC compatible - Precise, accurate, linear & reproducible
  • Convenient & easy to transfer - Available as frozen kits or continuous culture cell line


Assay Protocol

Example Assay Verification Data

    
   
A few examples from over 35 bioassays developed for biosimilars that can be used for both potency and NAb assays. A. Bioassay for Insulin demonstrates high reproducibility with three separate plates tested in a cell-based functional assay. B. GLP1 and Exendin-4 bioassay has been developed to accelerate development of biosimilars to metabolic drugs using a cyclic AMP readout in live cells. C. Bioassay developed for anti-TNFa drugs enables one to benchmark drugs like Humira, Remicade, Enbrel or Cimzia against the appropriate biosimilar molecule. D. A simple assay to determine potency of anti-VEGF-A antibodies for drugs like Avastin and its biosimilars.