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Developing innovative therapeutics requires commitment. Commitment to discovery. Commitment to quality. Commitment to process.
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Follow the Analytical Characterization Tools path to find technologies that lead to more precise large molecule characterization.
Navigate Functional Bioassays to find the latest cell-based reporter bioassays to help you stay on the leading edge of the rapid evolution of therapeutic strategies.
Biologics Tool Kit
Development of antibody-based therapeutics requires quantitative MOA-based bioassays during all stages of drug research and development. If your interests include peptide mapping, glycan analysis or stability testing of large protein molecules explore our portfolio assays.
Incorporating commercially available assays, with industry standard technologies can help your program advance more quickly and efficiently. Explore Promega's growing Bioassay portfolio.
Traditional cell killing assays using primary PBMCs or NK cells are highly relevant measures of antibody Fc effector activity. However, these assays are highly variable and often fail to yield quantitative and reproducible data required for drug discovery and development.
Promega’s Fc Effector Bioassays utilize a reporter-based luciferase readout as a surrogate measure of Fc receptor-mediated signaling. The bioassays are specific, qualified according to ICH guidelines, and correlate with primary cell-based killing assays.
Bispecific antibodies can be used to redirect T cells to kill tumor cells. Assays typically used to measure the activity of T cell bispecific antibodies typically rely on T cell activation and/or target cell killing endpoints. Promega’s T Cell Activation Bioassays shorten the time and reduce the variability associated with traditional readouts such as proliferation and cytokine production. Promega technologies used to measure target cell specific killing enable a larger assay window by eliminating signals coming from non-target cells.
Immune checkpoint receptors are promising new immunotherapy targets for the treatment of a variety of cancers and autoimmune-mediated disorders.
Promega has developed a suite of reporter-based bioassays to measure the activity of biologics designed to modulate the activity of co-inhibitory and co-stimulatory immune checkpoint receptors.
Therapeutics designed to either enhance or block cytokine activity have traditionally been measured using primary cells with readouts that may include proliferation, FACS, and ELISAs. While physiologically relevant, these assays may suffer from variability and complex workflows.
Employing a luciferase-based reporter assay offers the advantage of a simplified, homogenous workflow with high data quality. Promega has a rapidly growing portfolio of cytokine and growth factor bioassays and cell lines.
Antibody Drug Conjugates (ADC) aim to take advantage of the specificity of monoclonal antibodies (mAbs) to deliver potent cytotoxic drugs selectively to antigen-expressing tumor cells. Promega offers a suite of robust and reproducible assays to monitor the key attributes of ADC including internalization and cell health in real-time or endpoint. Cell Health assays include toxicity, viability, cellular metabolism, and apoptosis.
Promega is a global leader and partner in providing innovative solutions and technical support for biologics drug development. Promega’s bioassay platform yields quantitative, reproducible, and robust assays with a simple and flexible workflow. We maintain a dynamic pipeline of bioassays and seeks to partner with drug developers in the early stages of development to ensure that our bioassays meet your needs. Explore the benefits of partnering with Promega.
Antibody Drug Conjugates (ADC) are designed to selectively kill tumor cells via delivery of potent cytotoxic drugs. Promega offers a suite of robust and reproducible assays to monitor the key attributes of ADC including internalization and cell health in real-time or endpoint. Cell Health assays include toxicity, viability, cellular metabolism, and apoptosis.
Measure cellular responses to antibody drug conjugates using any cell line. Promega offers a suite of robust and reproducible assays to quantify cellular readouts such as cell viability, cytotoxicity, and apoptosis detection. RealTime kinetic assays and endpoint assays enable multi-dimensional analysis of the impact of ADC products on cellular models.
Our collection of proteases and other protein analysis reagents for biologics testing include antibody-specific proteases such as IdeS and IdeZ, a variety of general proteases (i.e. g trypsin or Lys-C), and glycosidases. We also have pH-reactive dyes for antibody internalization assays and systems for capture and purification.
Our collection of proteases and other protein analysis reagents for biologics testing include antibody-specific proteases such as IdeS and IdeZ, and a variety of general proteases (i.e. g trypsin or Lys-C), glycosidases. We also have pH-reactive dyes for antibody internalization assays and systems for capture and purification.
Improve protein sample prep workflow with rapid digestion, improved sequence coverage and more data from minimal sample material.
Rapid, simple and robot-friendly antibody purification beads and systems for your manual and automated purification needs.
Characterize proteins and antibodies, study glycosylation, perform digestions faster using alternative proteases and trypsin. Find mass spec reference reagents to quantify and qualify your mass spec instruments.
In Complement Dependent Cytotoxicity (CDC) assays, antibodies bind to surface antigens on the target cell and stimulate a complement cascade, where complement binds to the antibodies and induces a membrane attack complex, lysing the target cell. CDC activity is monitored using assays to measure cell death. Promega’s cytotoxicity assays are robust and reproducible, amenable for measuring the activity of biotherapeutics that act through the CDC pathway.
Fold Induction = 56EC50 = 16.8 ng/ml
Fold Induction = 13EC50 = 331 ng/ml
Fold Induction = 70RituximabEC50 = 35.7 ng/mlADCP Control Ab, Anti-CD20EC50 = 44.3 ng/ml
Fold Induction = 90EC50 = 28.7 ng/ml
Fold Induction = 29EC50 = 0.6 ng/ml
Fold Induction = 100EC50 = 74 ng/ml
Fold Induction = 102EC50 = 19.6 ng/ml
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Fold Induction = 40EC50 = 3.39 pM
Fold Induction = 150EC50 = 3.89 pM
Fold Induction = 7.6EC50 = 6.4 pM
Make Target cells that stably and constitutively express Luciferase and show that RLU is proportional to cell number. When Targets are mixed with Effector cells, the measured RLU is inversely proportional to cell death.
Average Fold Induction = 120.9 in 384 well plates
Characterization of Bispecific T-cell Engager (BiTE®) Antibodies with a High-Capacity T-cell Dependent Cellular Cytotoxicity (TDCC) Assay.
Aaron A. Nazarian1, Ivonne L. Archibeque2, Yen H. Nguyen1,Paul Wang1, Angus M. Sinclair2, and David A. Powers1
1 Therapeutic Discovery, Amgen Inc., Thousand Oaks, CA, USA2 Oncology Research, Amgen Inc., Thousand Oaks, CA, USA
Journal of Biomolecular Screening, p.1–9, 2014
Fold Induction = 20EC50 = 2 ng/ml
Fold Induction = 16EC50 = 39 ng/ml
Fold Induction = 11EC50 = 4.1 ng/ml
Fold Induction = 26EC50 = 50 ng/ml
Fold Induction = 1,531EC50 = 2.4 ng/ml
EC50 = 1.1 ng/ml
Fold Induction = 1,220EC50 = 0.35 ng/ml
Cells are transiently transfected and assayed to show proof of concept.
Promega’s Functional Bioassays methodology is designed to develop robust assays with a minimum amount of work. Stable cell clones are used in Design of Experiments (DoE) studies to identify and optimize critical assay parameters.
The use of cryopreserved Thaw & Use cells ensures bioassay reproducibility and transferability, and enables a more streamlined workflow compared with continuously cultured cells.
Our bioassays are pre-qualified according to ICH guidelines.
The PD-1/PD-L1 Blockade Biaossay was pre-qualified according to ICH guidelines. The data below show relative potency, repeatability, and linearity using an anti-PD-L1 blocking antibody.
Don't see a bioassay for your target(s) of interest? Contact us to talk with an R&D scientist about your project needs. Promega maintains a dynamic pipeline of bioassays and seeks to partner with drug developers in the early stages of development to ensure that our bioassays meet your needs. Through these partnerships you gain early access to our newest bioassay technology.
Talk to a scientist to receive more information about early access to our bioassays.
Promega bioassays are currently run in over 40 CROs globally. Promega enables CRO access to Promega bioassays through a variety of mechanisms including direct purchase for use in client services as well as client transfer of bioassays to a CRO.
Please contact Promega to discuss your specific CRO needs.
Our Custom Assay Services team will collaborate with you to build a custom bioassay that meets your needs. Projects are milestone based and payments are made upon completion of each.
Please contact Promega to discuss a custom assay solution.
EC50 = 0.44 μg/ml
Fold Induction = 5.0EC50 = 0.66 μg/ml
Fold Induction = 10.3EC50 = 3.65 μg/ml
Fold Induction = 5.2EC50 = 810 ng/ml
Fold Induction = 8.3EC50 = 1.3 μg/ml
Fold Induction = 25EC50 = 0.56 μg/ml
Fold Induction = 11,EC50 = 64.1 ng/ml
Fold Induction = 52EC50 = 58.8 ng/ml
Fold Induction = 15EC50 = 32.9 ng/ml
Fold Induction = 89EC50 = 50.4 ng/ml
EC50 = 63 ng/ml
Assay in Development
Used with co-stimulatory reporter bioassays to provide antibody cross-linking.
There are three possible responses when the FcyRIIb CHO-K1 Cells are used in conjunction with a co-stimulatory bioassay:
Fold Induction = 9.1EC50 = 2.3 µg/ml
Magne Protein A and Magne Protein G Beads use a novel HaloTag chemistry to immobilize Protein A and Protein G in a covalent and oriented fashion on to porous cellulose beads.
Minimize purification losses and increase sample throughput with exceptional magnetic properties.
Magne® Protein G and Magne® Protein A Beads
High Capacity Magnetic Streptavidin Beads are well suited for pharmacokinetic studies of therapeutic antibodies during preclinical studies.
Characterize a variety of antibody concentrations with a small amount of beads. Drug discovery teams use these beads for affinity enrichment and on-bead de-glycosylation of therapeutic antibodies from patient serum or plasma.
A key feature of pHAb Dyes is that they have two sulfonate groups per dye, which increases solubility and reduces the aggregation often seen with other non-sulfonated dyes. pHAb Dyes maintain their fluorescence response to pH change even after antibody conjugation.
CellTiter-Glo® 2.0 measures ATP, a key indicator of cell health. Based on the original CellTiter-Glo® Assay chemistry, it is a single-reagent format with improved stability for convenient storage and simpler setup. Whether you perform assays in a single plate or process hundreds of plates at a time, the ready-to-use reagent is designed for fast and easy everyday use. A highly sensitive assay with broad linearity, it is amenable to high throughput screening and multiplex applications.
The assay provides a proluminescent caspase-3/7 DEVD-aminoluciferin substrate and a proprietary thermostable luciferase in a reagent optimized for caspase-3/7 activity, luciferase activity and cell lysis. Adding the single Caspase-Glo® 3/7 Reagent in an "add-mix-measure" format results in cell lysis, followed by caspase cleavage of the substrate. This liberates free aminoluciferin, which is consumed by the luciferase, generating a "glow-type" luminescent signal that is proportional to caspase-3/7 activity.
With this real-time assay, repeated measures of luminescence and fluorescence from the same well during compound exposure allow determination of compound potency using far fewer plates and less reagents than endpoint assays. The reagent is well tolerated by a variety of cultured cell types and can be applied prior to treatment or at dosing for real-time measurement of the dose and time-dependent magnitude of apoptotic progression.
The AccuMap™ protocol optimizes the typsin:protein ratio and the digestion time to minimize baseline noise.
UV-HPLC chromatograms of Panitumumab digests. Panitumumab was predigested with AccuMAP™ Low pH Resistant rLys-C, then the reaction was diluted and digestion was completed by incubation with trypsin for 3 hours (upper panel) or overnight (lower panel). In this experiment we used a 1:5 trypsin:protein ratio. Note the accumulation of baseline noise for the overnight digest shown in the lower panel.
IdeS and IdeZ Protease are immunoglobulin G (IgG)-degrading enzymes that are valuable tools for the characterization of therapeutic antibodies, Fc fusion proteins and antibody-drug conjugates.
IdeS and IdeZ Proteases are fast, easy-to-use proteases; complete digestion can be achieved in 30 minutes without optimization. Cleavage is highly reproducible and specific, at a single site below the hinge region.
Isoaspartic acid residues in proteins and peptides can result from the gradual, nonenzymatic deamidation of asparagine or rearrangement of aspartic acid residues during storage or handling. Isoaspartyl formation may limit the useful lifetime of a protein.
Use the ISOQUANT® Isopartate Detection Kit to quantitate isopartic acid residues in proteins and peptides.
The Rapid Digestion-Trypsin and Rapid Digestion-Trypsin/Lys-C Kits are designed to shorten protein digestion times to 60 minutes versus the typical 4–18 hours required for protein digestion. Both kits contain three components: i) protease (Trypsin or Trypsin/Lys-C Mix); ii) protease Resuspension Buffer; and iii) Rapid Digestion Buffer optimized for faster digestions.
Protein digestion with these kits follows a simple-to-use protocol that is both fast and efficient. The protocol is flexible, can accommodate a large range of sample volumes and protein concentrations and requires no special laboratory equipment or off-line desalting. The entire sample preparation procedure is performed in as little as 60 minutes.
Lys-C compensates for trypsin lysine site cleavage inefficiency. Trypsin and Lys-C work simultaneously to digest proteins under conventional non-denaturing conditions. This provides the opportunity to improve trypsin digestion without procedural changes. This combination is also effective for sequential protein digestion.
Minimize Protein Digestion Time, Maximize Results
Use ProteaseMAX™ to enhance enzymatic performance of trypsin, chymotrypsin and Lys-C during in-gel protein digestion. This surfactant improves all in-gel digestion steps including peptide recovery. Complete a two-day procedure in one hour.
CDC activity can be measured using CytoTox-GloTM Cytotoxicity Assay, a sensitive, luminescent measurement of cytotoxicity due to loss of membrane integrity. The assay detects dead cells by measuring the extracellular activity of a distinct intracellular protease when released from membrane-compromised cells.
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