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

Product List

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All Targets List

Biologics Target List

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

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)

*HS Bioassay kits have been further optimized to deliver reproducible results with lower variability.

Target-Based Bioassays

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)

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.

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

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

CMO = contract manufacturing company; CDMO = Contract Development and Manufacturing Organization; and CRO = Contract Research Organization

Eurofins DiscoverX Bioassays Save over 12 Months of Assay Development Time

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.

Well-Structured Development Process Delivers Robust and Reproducible Assays

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.

Industry Requirements Drive Bioassay Development Strategy

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.

MOA-Reflective Bioassays Deliver Highly Specific Responses

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.

Application Notes Implementing MOA-Reflective ADCC Assays using Ready-to-Use KILR Target and Effector Cells from Screening to Lot Release

The development of antibody-based therapeutics to target the killing of tumor cells has revolutionized the space of immuno-oncology and the…

Application Notes A Simple & Powerful Cell-Based Assay to Quantify Specific Target Cell Death by Antibody-Dependent Cellular Phagocytosis (ADCP)

With the increasing industry focus on antibody drugs, there is an ever-greater need for functional bioassays that interrogate the therapeutic…

Application Notes Automating Cell-Based Bioassay on Tecan®’s Fluent Automation Workstation: Measuring PD-1 Signaling

An Application Note on automating Eurofins DiscoverX Cell-Based PathHunter® PD-1 Signaling Bioassay to bring high-throughput efficiencies to assay workflows. The…

Application Notes Automating Cell-Based Bioassays on Tecan®’s Fluent Automation Workstation: Measuring β-Arrestin Recruitment of Cannabinoid Receptor 1

Through early discovery, screening, characterization, and particularly for market release and commercialization of biologics, drug candidates require physiologically relevant, functional…

Scientific Posters Quantify Antibody-Dependent Cell Phagocytosis (ADCP): Application of a Robust, Non-Radioactive KILR Cytotoxicity Platform

Cell-based assays play an important role in determination of mechanism of action (MOA) for therapeutic antibodies, particularly when evaluating their…

Scientific Posters Novel, Improved Cell-Based Assays to Enable Immunotherapy Drug Development for Checkpoint Receptors

Regulation of immune responses is tightly controlled through a balance of co-stimulatory and inhibitory checkpoint receptors, often exploited by many…

Scientific Posters Building Robust and Simple Cell-Based Assays for Interleukins and Their Receptors

Ligand-induced receptor dimerization is an early functional step in receptor activation, representing the most proximal, functional readout for Interleukin receptors.…

Scientific Posters Advances in tools to compare potency, efficacy, safety & quality of follow-on biologics or biosimilars

Regulatory authorities define biosimilars as drugs that are “highly similar” to or “interchangeable” with an approved biologic. The lack of…

Scientific Posters Development and Evaluation of a Novel Bioassay for Denosumab Activity

Denosumab (Prolia®) is a fully human sequence derived monoclonal antibody used for the treatment of osteoporosis in menopausal women via…

Scientific Posters Development of Simple, Robust Bioassays for Biosimilar & Biobetter Development

One of the major bottlenecks in the development of biosimilars is the need for good bioassays to create potency, stability…

Scientific Posters Qualified, Fit-for-Purpose Bioassays for Liraglutide and Exenatide as Frozen Ready-to-Use Cells

With more than 25% of the world’s population diagnosed with type II diabetes and/or metabolic syndrome, the requirement for cost…

Scientific Posters Ready-to-use potency assays for anti-VEGF drugs such as Bevacizumab

Cell-based bioassays often pose a hurdle during a rapidly moving biologics development program. High standards for assay accuracy, precision, reproducibility…

Scientific Posters Ready-to-Use Potency Assays for Bevacizumab, Aflibercept, & Ranibizumab

Cell-based bioassays often pose a hurdle during a rapidly moving biologics development program. High standards for assay accuracy, precision, reproducibility…

Scientific Posters Robust and Simple Potency and NAb Bioassays for Avastin® Biosimilar Development

One of the major bottlenecks in the development of biosimilars is the need for good bioassays to create potency, stability…

Scientific Posters Simple, Reproducible & Robust Bioassays in Cryopreserved Ready-To-Assay Format

Cell-based bioassays often pose a hurdle during a rapidly moving biologics development program. High standards for assay accuracy, precision, reproducibility…

Scientific Posters Validated Bioassays for Potency, Stability and Lot Release Testing of Biopharmaceuticals

Biologics represents one of the fastest growing classes of biopharmaceutical molecules today. One of the major bottlenecks in the development…

Scientific Posters Development of Novel Cell-based Assays to Detect Neutralizing Antibodies to Therapeutic Biologics

Neutralizing antibodies (NAbs) to biological drugs may cause loss of therapeutic efficacy and in some cases, loss of endogenous protein…

Scientific Posters Validated Cell-Based Assays for Rapid Screening and Functional Characterization of Therapeutic Monoclonal Antibodies

Monoclonal antibodies (MAbs) represent one of the fastest growing classes of biotherapeutic molecules today. While many technologies exist for generating…

Scientific Posters Ready-to-Use Cell-Based Assays to Enable Immunotherapy Drug Development for Checkpoint Receptors

Regulation of immune responses is tightly controlled through a balance of co-stimulatory and inhibitory checkpoint receptors, often exploited by many…

Scientific Posters New PathHunter Reporter Assays: Analysis of PD-1 Checkpoint Receptor and NFAT Signaling Pathways

Reporter genes are a well-established method used to develop cell-based assays for testing drugs that inhibit targets involved in specific…

Scientific Posters Improved Cell-Based Assays To Assess Therapeutic Molecules Against Immune Checkpoint Receptors Such As PD-1, PD-L1 and PD-L2

Regulation of immune responses is tightly controlled through a balance of co-stimulatory and inhibitory checkpoint receptors, often exploited by many…

Scientific Posters Comprehensive & Fit-For-Purpose Solutions to Enable Drug Development for Cytokine Targets

Interleukins are known for their involvement in functioning of both the adaptive and innate immune systems. Interleukins direct immune cells…

Scientific Posters Accelerate Drug Development of GLP-1 & -2 Receptor Analogs with Ready-to-Use Cell-Based Assays

There is an increasing need to generate therapeutics targeting metabolic and gastrointestinal diseases to address the global burden of metabolic…

Scientific Posters Implementing MOA-Reflective ADCC Assays using Ready-to-Use KILR Target and Effector Cells from Screening to Lot Release

The clinical success of an ever-increasing array of biologics has led to the development of a wide spectrum of immunomodulatory…

Presentations [PEGS 2022] Implementing MOA-Reflective ADCC Assays using Ready-to-Use KILR Target and Effector Cells from Screening to Lot Release

Gaurav Agrawal, Ph.D.Scientific Development Manager

Presentations [WCBBA 2022] Accelerating Potency Bioassay Implementation from Development to QC Lot-Release & Ensuring Long-term Assay Reproducibility

Alpana Prasad, Ph.D. Director, Innovations and Strategic Partnership

Presentations [Cytokines Summit 2022] Enabling Cytokine Therapeutic Development with Qualified, Functional Cell-Based Assays

Gaurav Agrawal, Ph.D.Scientific Development Manager Discover how cell-based assays and translational services accelerate cytokine-based immunotherapeutic development from early discovery to…

Presentations [Immuno-Oncology UK 2021] Accelerating Immunotherapy Drug Development with Simple Cell-Based Assays for Immune Checkpoint Receptors

Andrew Green Senior Business Development Manager

Presentations [DOT 2021] Functional, Automatable & MOA-Reflective Cell-Based Bioassays for Accelerating Drug Discovery & QC Lot Release Programs

Gaurav Agrawal, Ph.D. Scientific Development Manager, Eurofins DiscoverX

Presentations [CD47/SIRPa Summit 2020] A Novel MOA-reflective Bioassay for Quantifying Potency of Therapeutics Targeting the SIRPα|CD47 Signaling Axis

Watch Recorded Presentation Jane Lamerdin, Ph.D. Director R&D, Eurofins DiscoverX

Presentations [BEBPA NA 2020] Qualification of Ready-to-Use Cell-Based Assays for Potency to Support Immunology and Immunotherapy Drug Development

Presenter: Jane Lamerdin, Ph.D., Director of R&D, Eurofins DiscoverX

Presentations [BEBPA USA 2017] Optimizing and Qualifying Bioassays for Biosimilars, Biobetters, and Innovator Drugs

Presented by Jane Lamerdin, Ph.D. March 9, 2017 BEBPA 2017, San Francisco, CA

Presentations [DOT 2020] Accelerate Your COVID-19 Drug Discovery with Qualified Cell-Based Assays for Proinflammatory Cytokines

Gaurav Agrawal, Ph.D. Scientific Development Manager, Eurofins DiscoverX

Presentations [EU PEGS 2022] Implementing MOA-Reflective Cytotoxicity Assays Using Ready-to-Use KILR®Target & Effector Cells from Screening to Lot Release

Andrew Green Sr. Business Development Manager

Presentations [Festival of Biologics EU 2021] Accelerating Immunotherapy Drug Development Targeting Checkpoints with Robust MOA-Based Assays

Presented by Dr. Alexander Baumann Head of European Business Development Eurofins DiscoverXProducts

Presentations [Immuno-Oncology Summit 2021] Accelerating Immunotherapy Drug Development with Simple Cell-Based Assays for Immune Checkpoint Receptors

Jennifer Lin-Jones, Ph.D. Senior Group Leader, Assay Development

Presentations [IO Summit 2022] Implementing MOA-Reflective ADCC & ADCP Cytotoxicity Assays Using Ready-to-Use KILR® Target & Effector Cells from Screening to Lot Release

Jane E. Lamerdin, Ph.D. Vice President, Research & Development Eurofins DiscoverX

Presentations [PEGS 2021] Accelerating Development of Therapeutic Interventions for COVID-19

Gaurav Agrawal, Ph.D. Scientific Development Manager Abstract Millions of deaths worldwide have been attributed to COVID-19, caused by the SARS-CoV-2…

Presentations [WCB 2020] Accelerate Your COVID-19 Drug Discovery with Qualified Cell-Based Assays for Proinflammatory Cytokines

Gaurav Agrawal, Ph.D. Scientific Development Manager, Eurofins DiscoverX

Presentations [PEGS 2023] Accelerating Immuno-Oncology Drug Discovery with MOA-Reflective, Functional Cell-Based Assays

Venkatesh Chari, Ph.D. Scientific Market Development Manager Eurofins DiscoverX Products LLC

Target Lists Cell-based Assays for Biologics Development Programs

Accelerate your biologics development from discovery to QC lot release with cell-based assays. Comprehensive list of bioassay kits, cell lines,…

Target Lists Products Target List

Comprehensive Eurofins DiscoverX product list to enable your drug discovery and development programs focused on checkpoint receptors, cytokine receptors/interleukins, cytotoxicity,…

Target Lists GPCR Product Solutions

Your source for a complete offering of GPCR assays, cell lines, and membrane preps

Target Lists Kinase and Phosphatase Product Solutions

Comprehensive Offering of Cellular Assays and Recombinant Enzymes for Drug Discovery Screening and Lead Optimization

Webinars Validated bioassays for metabolic & gastrointestinal diseases: Accelerating development of GLP-1 & -2 therapeutics

Therapeutics targeting glucagon-like peptide, GLP-1 and GLP-2, receptors are being developed to address globally prevalent medical disorders for managing diabetes,…

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Webinars Roundtable Webinar: Accelerating Your Biologics Therapeutics Development with Bioassays

Bioassays are critical components of the quality control system for characterizing biologics. This roundtable involves an interactive panel discussion with…

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Webinars Automating Functional Cell-based Bioassays: Assay Reproducibility and Performance for Potency Testing Programs

Throughout early discovery and particularly for market release, biologic drug candidates require mechanism-of-action (MOA)-based functional, cellular assays as characterisation tools…

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Webinars Accelerating COVID-19 Drug Discovery: Qualified Cell-Based Assays for Proinflammatory Cytokines

COVID-19 has been declared a global pandemic by WHO. The disease is transmitted when the SARS-CoV-2 virus infects the respiratory…

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Webinars Establishing Qualified Bioassays for Checkpoint Receptors to Implement in QC Lot Release: Case Studies on PD-1 and SIRPα

Regulation of immune responses is tightly controlled through a balance of co-stimulatory and inhibitory checkpoint receptors, which is often exploited…

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Webinars Accelerate Biologics and Biosimilars Development: Case Studies Implementing Robust and Simple Potency Bioassays

A quantitative and robust bioassay that is reflective of the MOA of the drug is a critical component of any…

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Webinars Cytotoxicity Bioassays – Measuring Antibody-Mediated Direct Cell Death

The webinar focusses on measuring antibody-mediated cell death using DiscoverX’s KILR Bioassays, and how they can be used to measure…

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Webinars Functional Assays for the Development of Agonistic Abs for Immunotherapies

Watch this webinar to discover qualified bioassays assessing therapeutic antibody mechanisms, case studies about agonistic effects in antibodies initially deemed…

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White Papers Accelerating Biosimilar & Biobetter Drug Development: Ready-to-Use, Cell-Based Assays for Potency and Lot Release Testing

With the drug industry’s expanding emphasis on biologics, the need for robust cell-based assays has grown at all stages of…

White Papers Accelerating Immune Checkpoint Drug Discovery through Functional Cell-Based Assays

Immune checkpoint receptors play a key role in maintaining antitumor immunity, avert immunopathology, and modulate overall immune homeostasis. However, cancer…

Case Studies Evaluating Checkpoint Receptor Bioassays: Fit-For-Purpose Assays Intended for Potency Testing of Therapeutic Candidates in QC Lot Release

Ready-to-Use qualified PathHunter® checkpoint bioassays are fit-forpurpose for potency testing for implementation in downstream development phases and Lot release of…

Case Studies Implementing Robust & Reproducible KILR® Ready-to-Use Bioassays from Screening to Lot Release: Applications for Measuring Direct Cytotoxic Cell Death

Therapeutic regulators require assay data on the impact of Fc effector-mediated function of antibodies during their development as therapeutics. The…

Videos Cell Banking for Bioassays

Learn how to confidently de-risk your biologics’ lot-release strategy by establishing a dedicated analytical cell banks for your bioassay. Find…

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Videos Accelerating Immuno-Oncology Drug Discovery with MOA-Reflective, Functional Cell-Based Assays

Listen to the US PEGS 2023 conference talk by Venkatesh Chari, Ph.D. on MOA-reflective, functional cell-based assays (cell lines and…

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Videos A Novel MOA-reflective Bioassay for Quantifying Potency of Therapeutics Targeting the SIRPα|CD47 Signaling Axis

Learn about the first commercially available SIRPα/CD47 cell-based assay — PathHunter SIRPα Signaling Assay. Find out more about the generation…

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Videos Novel Cell-Based Assays to Enable Immunotherapy Drug Development for Checkpoint Receptors

Learn about PathHunter® checkpoint receptor assays (cell lines and bioassays) for innate and adaptive immunity. Assays discussed include functional cell-based…

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Videos Custom Development Capabilities

Learn about Eurofins DiscoverX cell line engineering, assay development, and recombinant enzyme production custom capabilities. Find out more about cell…

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Blogs & Articles Accelerating Development of GLP-1 & GLP-2 Therapeutics with Validated Bioassays

Glucagon-like peptides, GLP-1 & GLP-2, are well-researched, metabolically significant peptide hormones secreted from the L-cells of the small intestine in…

Blogs & Articles Evaluate GLP-1R Targeted Therapeutics using First-to-Market Semaglutide Qualified GLP-1R Bioassay

Glucagon-Like Peptide-1 (GLP-1), a member of the glucagon-secretin peptide family, is secreted from L-cells of the small intestine and binds…

Blogs & Articles Accelerating Biologics Therapeutics with Bioassays: An In-Depth Discussion on the Essence of Bioassays Implemented for Drug Development

Eurofins DiscoverX, in conjunction with Drug Target Review, sponsored and moderated a Bioassay roundtable discussion webinar with group leaders from…

Blogs & Articles Accelerating Cytokine Drug Discovery and QC Lot Release Testing with Qualified, Functional Cell-Based Assays

Cytokines and their receptors have emerged as major drug targets for inflammatory and autoimmune diseases, allergies, and, more recently, in…

Blogs & Articles Use of Automated Functional, Cell-Based Bioassays

Importance in Drug Discovery & Development for Quality Testing Programs. GPCR CNR1 Bioassay example.

Blogs & Articles Targeting Pro-Inflammatory Cytokines for COVID-19 Therapy: Cell-Based Assays for Accelerated Drug Discovery

The COVID-19 pandemic has left us racing against time for remediation. As a result, we have witnessed hundreds of therapeutic…

Blogs & Articles Accelerating Biologics Development Programs With Phase-Appropriate Ready-To-Use Potency Bioassays

Biological activity of a biotherapeutic is a Critical Quality Attribute (CQA), which needs to be accurately measured by an appropriate…

Qualification Data Adalimumab Bioassay Kit Qualification Data

Qualification Data Anakinra Bioassay Kit Qualification Data

Qualification Data Anti-VEGF Bioassay Kit Qualification Data

Qualification Data EPO Epoetin_Darbepoetin Bioassay Kit Qualification data

Qualification Data Exenatide Bioassay Kit Qualification Data

Qualification Data FollitropinAlfa_Bioassay Kit Qualification Data

Qualification Data Insulin Bioassay Kit Qualification Data.pdf

Qualification Data Liraglutide Bioassay Kit Qualification Data

Qualification Data Panitumumab Bioassay Kit Qualification Data

Qualification Data PD-1 Signaling Bioassay Kit Qualification Data

Qualification Data Pertuzumab Bioassay Kit Qualification Data

CDMO/CRO Certification Program for Cell-Based Assays

Program designed to qualify CRO/CDMOs to run Eurofins DiscoverX bioassays for client downstream therapeutic efforts

Cell Banks for Bioassays

Ensure long-term assay reproducibility with the production of bioassay cells — critical reagents for cell banks

Potency and QC Lot-Release Testing Solutions

Providing functional, MOA-based bioassays with superior lot-to-lot reproducibility

Checkpoint Receptor Assays

Accelerate cancer immunotherapy drug development with easy-to-use, functional cell-based assays

KILR® Cytotoxicity Product Solutions

Simple, non-radioactive, & dye-free cytotoxicity assays to specifically measure target cell death

Cytokine Receptor Product Solutions

Comprehensive portfolio of cell-based, functional assays for cytokines & interleukin receptors

GPCR Product Solutions

Cell-based assays to measure 2nd messengers (cAMP & calcium), β-arrestin recruitment, receptor internalization, & ligand binding

Kinase Product Solutions

Enzymes & cell-based functional, binding, & activity assays for discovery through development & for QC lot-release testing

Custom Capabilities

Custom cell lines, kits, assays, & protein development capabilities optimized to fit your requirements

BIOASSAYS FOR BIOLOGICS