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FcγRIIa-H ADCP Bioassay

Measure Potency and Stability of Biologics that Bind and Activate ADCP through FcγRIIa-H

  • Available in two kit formats:
  • Complete, everything you need to get started
  • Core, used with customer-defined Ab and target cells

Choose a kit format

Choose an option

Catalog number selected: G9901

$ 980.00
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This product is discontinued
FcγRIIa-H ADCP Bioassay
Complete/1 System
$ 980.00
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32454665-ADCC-overview-header

Measure Potency and Stability of Biologics that Bind and Activate FcyRIIa-H

Antibody-dependent cell-mediated phagocytosis (ADCP) is an important mechanism of action (MOA) of therapeutic antibodies. In vivo, ADCP can be mediated by monocytes, macrophages, neutrophils and dendritic cells via FcγRIIa, FcγRI and FcγRIIIa. While all three receptors can participate in ADCP, FcγRIIa is believed to be the predominant Fcγ receptor involved in this process.

The FcγRIIa-H ADCP Reporter Bioassay is a biologically relevant MOA-based assay that can be used to measure the potency and stability of antibodies and other biologics that specifically bind and activate FcγRIIa. The assay consists of Jurkat cells stably expressing human FcγRIIa-H (the high-affinity H131 variant) and NFAT-induced luciferase.

The Workflow

12052MA-W
12052MB-W

Standardized Reagents Improve Results

  • Thaw-and-use cell format provides significant time and labor savings over traditional methods while reducing variability.
  • Kit includes all of the required reagents in standardized formats.
  • Easily amenable to high-throughput workflows.

The Assay Principle

The Fc Effector Reporter Bioassays use an alternative readout from traditional primary cell based assays: the FcγR and NFAT-mediated activation of luciferase activity in the effector cells. Primary cells are replaced with a Jurkat cell line stably expressing human FcγRIIa H-131and NFAT-induced luciferase.

10338MA-W

Luminescent Assay Monitors Fc Effector Activity

Following engagement with the Fc region of a relevant antibody bound to a Target Cell, ADCP Bioassay Effector Cells expressing FcγRIIa-H131 with transduce intracellular signals resulting in NFAT-RE-mediated luciferase activity that can be easily quantified.

Assay Performance Data

Accuracy and Precision are critical to bioassays and the development of new biologics. The ADCP Reporter Bioassays are both accurate and precise and have been prequalified according to ICH guidelines and shows the precision, accuracy and linearity required for routine use in potency and stability studies. Accuracy is a measure of how close results are to a target or reference value. Precision is a measure of repeatability.
32454665-data-target1
Accurate, but not precise

Accuracy

Measure of ability to replicate a reference or “target” value.

32454665-data-target2
Precise, but not accurate

Interlab Precision

Measure of repeatability from multiple assays of the same homogeneous sample under the same operating conditions over a short time (same analyst; same lab; same day).

32454665-data-target3
Precise and accurate

Intermediate Precision

Measure of repeatability of multiple assays of the same homogeneous sample with different analysts or equipment or on different days (many people).

32454665-data-linear
Linear

Linearity

Ability of your assay to provide measured values at are proportional to the concentration of the sample.

ADCP Reporter Bioassay Precision, Accuracy and Linearity

Raji Target Cells

Accuracy


Expected
Relative Potency
Recovery
50% 99.1%
75% 102.7%
150% 105.0%
200% 99.1%

Repeatability (100% reference, %CV)


6.5%

Intermediate Precision (%CV)


3.5%

Linearity


r2 = 0.997(50 – 200% range)
y = 0.997x + 1.95

The ADCP Bioassay reflects the MOA and specificity of antibodies designed to bind and activate FcγRIIa-H

13449MA-W-a
Increasing concentrations of trastuzumab (anti-HER2) or rituximab (anti-CD20) were incubated with SKBR3 (HER2+) target cells and FcγRIIa-H Effector Cells.
13449MA-W-b
Increasing concentrations of trastuzumab (anti-HER2) or rituximab (anti-CD20) were incubated with Raji (CD20+) target cells and FcγRIIa-H Effector Cells.
13449MA-W-c
Increasing concentrations of rituximab were incubated with Raji target cells and NFAT-RE eff ector cells either with or without FcγRIIa-H expression. Bio-Glo™ Reagent was added, and luminescence was measured. Data were fitted to a 4PL curve using GraphPad Prism® software.

Product Format

Complete Kits

  • Include FcγRIIa-H Effector Cells, Target Cells (Raji), Control Antibody, Cell Culture Medium and Assay Reagents.
  • Recommended for use as a starter kit.

Core Kits

  • Include FcγRIIa-H Effector Cells, Cell Culture Medium and Assay Reagents.
  • Recommended for routine use with customer-defined antibody and target cells.
  • Available in 1X and 5X sizes.
  • The bioassay is prequalified according to ICH guidelines and shows the precision, accuracy and linearity required for routine use in potency and stability studies. The bioassay workflow is simple and robust, compatible with 96-well and 384-well plate formats, and unlike traditional primary cell-based assays, amenable for use in quality-controlled drug development settings.

For additional product formats, please enquire.

32454665-ADCC-product-format

Specifications

You are viewing: G9901 Change Configuration

What's in the box?

Item Part # Size

FcγRIIa-H Effector Cells

G988A 1 × 0.62ml

RPMI 1640 Medium

G708A 1 × 36ml

Low IgG Serum

G711A 1 × 4ml

ADCP Control Ab, Anti-CD20

G989A 1 × 2.5μg

Target Cells (Raji)

G960A 1 × 0.55ml

Bio-Glo™ Luciferase Assay Buffer

G719A 1 × 10ml

Bio-Glo™ Luciferase Assay Substrate

G720A 1 × 1 vial

SDS

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Certificate of Analysis

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Use Restrictions

Not For Medical Diagnostic Use.

Storage Conditions

Please see the Protocol for detailed storage conditions.

Patents and Disclaimers

NOT FOR MEDICAL DIAGNOSTIC USE. FOR IN VITRO USE ONLY. BY USE OF THIS PRODUCT, RECIPIENT AGREES TO BE BOUND BY THE TERMS OF THIS LIMITED USE STATEMENT. If the recipient is not willing to accept the conditions of this limited use statement, and the product is unused, Promega will accept return of the unused product and provide the recipient with a full refund.

This product may not be further sold or transferred by the recipient and may be used only by the recipient, and then only for (1) research use, (2) discovery, development and monitoring of biologic drugs and vaccines, (3) quality assurance testing of biologic drugs and vaccines, and (4) product release assays for biologic drugs and vaccines. No other commercial use is allowed. "Commercial use” means any and all uses of this product by recipient for monetary or other consideration, including providing a service, information or data to unaffiliated third parties, and resale of this product for any use. Recipient has no right to propagate, modify, derivatize, genetically engineer or otherwise create variations of the cells or genes stably transfected within the cells. In addition, recipient must use Bio-Glo™ Luciferase Assay System purchased from Promega Corporation for all luminescence assays using this product or contact Promega to obtain a license for use of this product with reagents other than Promega’s. PROMEGA MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH REGARDS TO THIS PRODUCT. The terms of this agreement shall be governed under the laws of the State of Wisconsin, USA.

U.S. Pat. No. 8,008,006 and European Pat. No. 1341808.

Licensed from Lonza Cologne GmbH under U.S. Pat. Nos. 7,700,357, 8,192,990 and 8,003,389, European Pat. Nos. 1297119, 1522587, 1607484 and 1741778 and other pending and issued patents.

Product cannot be used for proficiency testing.

Specifications

You are viewing: G9991 Change Configuration

What's in the box?

Item Part # Size

FcγRIIa-H Effector Cells

G988A 1 × 0.62ml

RPMI 1640 Medium

G708A 1 × 36ml

Low IgG Serum

G711A 1 × 4ml

Bio-Glo™ Luciferase Assay Buffer

G719A 1 × 10ml

Bio-Glo™ Luciferase Assay Substrate

G720A 1 × 1 vial

SDS

Choose language:

Certificate of Analysis

See all certificates for G9991 Search
View more results
No results
Loading…

Use Restrictions

Not For Medical Diagnostic Use.

Storage Conditions

Please see the Protocol for detailed storage conditions.

Patents and Disclaimers

NOT FOR MEDICAL DIAGNOSTIC USE. FOR IN VITRO USE ONLY. BY USE OF THIS PRODUCT, RECIPIENT AGREES TO BE BOUND BY THE TERMS OF THIS LIMITED USE STATEMENT. If the recipient is not willing to accept the conditions of this limited use statement, and the product is unused, Promega will accept return of the unused product and provide the recipient with a full refund.

This product may not be further sold or transferred by the recipient and may be used only by the recipient, and then only for (1) research use, (2) discovery, development and monitoring of biologic drugs and vaccines, (3) quality assurance testing of biologic drugs and vaccines, and (4) product release assays for biologic drugs and vaccines. No other commercial use is allowed. "Commercial use” means any and all uses of this product by recipient for monetary or other consideration, including providing a service, information or data to unaffiliated third parties, and resale of this product for any use. Recipient has no right to propagate, modify, derivatize, genetically engineer or otherwise create variations of the cells or genes stably transfected within the cells. In addition, recipient must use Bio-Glo™ Luciferase Assay System purchased from Promega Corporation for all luminescence assays using this product or contact Promega to obtain a license for use of this product with reagents other than Promega’s. PROMEGA MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH REGARDS TO THIS PRODUCT. The terms of this agreement shall be governed under the laws of the State of Wisconsin, USA.

U.S. Pat. No. 8,008,006 and European Pat. No. 1341808.

Licensed from Lonza Cologne GmbH under U.S. Pat. Nos. 7,700,357, 8,192,990 and 8,003,389, European Pat. Nos. 1297119, 1522587, 1607484 and 1741778 and other pending and issued patents.

Product cannot be used for proficiency testing.

Specifications

You are viewing: G9995 Change Configuration

What's in the box?

Item Part # Size

FcγRIIa-H Effector Cells

G988A 5 × 0.62ml

RPMI 1640 Medium

G708A 5 × 36ml

Low IgG Serum

G711A 5 × 4ml

Bio-Glo™ Luciferase Assay Buffer

G719A 5 × 10ml

Bio-Glo™ Luciferase Assay Substrate

G720A 5 × 1 vial

SDS

Choose language:

Certificate of Analysis

See all certificates for G9995 Search
View more results
No results
Loading…

Use Restrictions

Not For Medical Diagnostic Use.

Storage Conditions

Please see the Protocol for detailed storage conditions.

Patents and Disclaimers

NOT FOR MEDICAL DIAGNOSTIC USE. FOR IN VITRO USE ONLY. BY USE OF THIS PRODUCT, RECIPIENT AGREES TO BE BOUND BY THE TERMS OF THIS LIMITED USE STATEMENT. If the recipient is not willing to accept the conditions of this limited use statement, and the product is unused, Promega will accept return of the unused product and provide the recipient with a full refund.

This product may not be further sold or transferred by the recipient and may be used only by the recipient, and then only for (1) research use, (2) discovery, development and monitoring of biologic drugs and vaccines, (3) quality assurance testing of biologic drugs and vaccines, and (4) product release assays for biologic drugs and vaccines. No other commercial use is allowed. "Commercial use” means any and all uses of this product by recipient for monetary or other consideration, including providing a service, information or data to unaffiliated third parties, and resale of this product for any use. Recipient has no right to propagate, modify, derivatize, genetically engineer or otherwise create variations of the cells or genes stably transfected within the cells. In addition, recipient must use Bio-Glo™ Luciferase Assay System purchased from Promega Corporation for all luminescence assays using this product or contact Promega to obtain a license for use of this product with reagents other than Promega’s. PROMEGA MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH REGARDS TO THIS PRODUCT. The terms of this agreement shall be governed under the laws of the State of Wisconsin, USA.

U.S. Pat. No. 8,008,006 and European Pat. No. 1341808.

Licensed from Lonza Cologne GmbH under U.S. Pat. Nos. 7,700,357, 8,192,990 and 8,003,389, European Pat. Nos. 1297119, 1522587, 1607484 and 1741778 and other pending and issued patents.

Product cannot be used for proficiency testing.

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