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FcγRI ADCP Bioassay

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Measure Potency and Stability of Biologics that Bind and Activate ADCP through FcγRI

  • Prequalified according to ICH guidelines
  • No primary cell culture required
  • Supplied in convenient thaw-and-use format; also available in cell propagation model (CPM) format

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Catalog number selected: GA1341

$ 1,000.00
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FcγRI ADCP Bioassay
Core Kit/1X Each Component
$ 1,000.00
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Demonstrate Antibody ADCP Activity Through FcγRI

Fc receptor-mediated antibody-dependent cell-mediated phagocytosis (ADCP) is an important mechanism of action (MOA) of therapeutic antibodies designed to recognize and mediate the elimination of virus-infected or diseased (e.g., tumor) cells. Unlike antibody-dependent cell-mediated cytotoxicity (ADCC), which is mediated primarily through FcγRIIIa expressed on NK cells, ADCP can be mediated by monocytes, macrophages, neutrophils and dendritic cells via FcγRIIa, FcγRIIIa and FcγRI. All three receptors can participate in antibody recognition, receptor clustering and signaling events that result in ADCP.

Current methods used to measure ADCP rely on the isolation of primary human monocytes, ex vivo differentiation into macrophages and measurement of target cell engulfment. These assays are laborious and highly variable due to complex assay protocols and unqualified assay reagents. As a result, these current methods are difficult to establish in quality-controlled, drug development settings.

The FcγRI ADCP Bioassay is a bioluminescent cell-based assay for measuring the potency and stability of antibodies and other biologics with Fc domains that bind and activate FcγRI. The assay consists of a genetically engineered Jurkat T cell line that expresses the high-affinity human FcγRI and a luciferase reporter. The bioassay workflow is simple, robust, consistent and overcomes many of the limitations of traditional methods.

Product Formats and Components

Core Kits (Cat.# GA1341, GA1345)

  • Includes FcγRI 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.

Cell Propagation Model (Cat.# GA1332)

  • Includes the FcγRI Effector Cells (CPM); these are cryopreserved cells that can be thawed, propagated and banked for long-term use.
  • Use with Bio-Glo™ Luciferase Assay System.

Cell Bank Format (Cat.# GA1330)

  • Available for customers who are planning to expand the CPM vials, but the expansion is done by Promega scientists.

Workflow

Standard bioassay workflow with cultured cells
Improved bioassay workflow with thaw-and-use cells

Standardized Reagents Improve Results

  • Thaw-and-use format provides significant time and labor savings over traditional methods while reducing variability.
  • Easily amenable to high-throughput workflows.

Assay Principle

The FcγRI Effector Reporter Bioassays use an alternative readout from traditional primary cell-based assays. Primary cells are replaced with a Jurkat cell line stably expressing human FcγRI and response element (RE)-mediated activation of luciferase activity in the effector cells.

18022ma

Representation of the FcγRI ADCP Reporter Bioassay. The bioassay consists of a genetically engineered cell line (FcγRI Effector Cells), an antigen expressing target cell and an antigen-specific antibody. When all components are cocultured, the antibody simultaneously binds target cell antigen and FcγRI receptors on the surface of the effector cells. This results in receptor clustering, intracellular signaling and luciferase activity.

Assay Performance Data

Representative data for the FcγRI ADCP Reporter Bioassay.

Representative data for the FcγRI ADCP Reporter Bioassay. Panel A. FcγRI ADCP Bioassay Effector Cells were treated with serial dilutions of Control Ab, Anti-CD20, and infliximab (anti-TNFα) in the presence of Raji target cells. Panel B. FcγRI ADCP Bioassay Effector Cells were treated with serial dilutions of Control Ab, Anti-CD20, in the presence or absence of Raji target cells. Data were generated using thaw-and-use cells. Luciferase activity was quantified using Bio-Glo™ Reagent, and plates were read on a GloMax® Discover System. Data were fitted to a 4PL curve using GraphPad Prism® software.

Specifications

You are viewing: GA1341 Change Configuration

What's in the box?

Item Part # Size

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

FcγRI ADCP Effector Cells

GA133A 1 × 0.7ml

Certificate of Analysis

Search by lot number

Use Restrictions

For Research Use Only. Not for Use in Diagnostic Procedures.

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. 10,077,244 and other patents.

U.S. Pat. No. 8,008,006.

Product cannot be used for proficiency testing.

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.

Specifications

You are viewing: GA1345 Change Configuration

What's in the box?

Item Part # Size

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

FcγRI ADCP Effector Cells

GA133A 5 × 0.7ml

Certificate of Analysis

Search by lot number

Use Restrictions

For Research Use Only. Not for Use in Diagnostic Procedures.

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. 10,077,244 and other patents.

U.S. Pat. No. 8,008,006.

Product cannot be used for proficiency testing.

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.

Specifications

You are viewing: GA1332 Change Configuration

What's in the box?

Item Part # Size

FcγRI ADCP Effector Cells (CPM)

GA133B 2 × 1ml

Certificate of Analysis

Search by lot number

Use Restrictions

For Research Use Only. Not for Use in Diagnostic Procedures.

Storage Conditions

XX

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 modify, derivatize, genetically engineer or otherwise create variations of the cells or genes stably transfected within the cells except that recipient may propagate and store the cells for long-term use. 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.

Product cannot be used for proficiency testing.

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.

Specifications

You are viewing: GA1330 Change Configuration

What's in the box?

Item Part # Size

FcγRI ADCP Effector Cells (CPM)

GA133B 50 × 1ml

Certificate of Analysis

Search by lot number

Use Restrictions

For Research Use Only. Not for Use in Diagnostic Procedures.

Storage Conditions

XX

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 modify, derivatize, genetically engineer or otherwise create variations of the cells or genes stably transfected within the cells except that recipient may propagate and store the cells for long-term use. 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.

Product cannot be used for proficiency testing.

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.

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