ADCP Reporter Bioassay (THP-1), Propagation Model Technical Manual

Instructions for Use of Product(s)
GA1272, GA6020

Literature # TM700

Current methods for measuring ADCP rely on isolating primary monocyte-derived macrophages and direct measurement of phagocytosis. These assays are laborious and highly variable due to their reliance on donor cells, complex assay protocols and unqualified assay reagents. As a result, these assays are difficult to establish in quality-controlled, drug-development settings.

The ADCP Reporter Bioassay (THP-1), Propagation Model (Cat.# GA1272) is a bioluminescent reporter cell-based assay that overcomes the limitations of existing assays. It can be used to measure the potency and stability of antibodies and other biologics with Fc domains that bind and activate FcγRI and/or FcγRIIa. The assay consists of a THP-1 monocyte cell-line with endogenous expression of FcγRI and FcγRIIa. This cell line has been genetically engineered to express a NanoLuc® (NL) Luciferase reporter driven by FcγR-dependent response elements. The ADCP Reporter Bioassay Effector Cells (THP-1) are provided in Cell Propagation Model (CPM) format, which includes cryopreserved cells that can be thawed, propagated and banked for long-term use. Cell banks for the ADCP Reporter Bioassay Effector Cells (THP-1) (Cat.# GA6020) are also available.

Summary of Changes
The following changes were made to the 4/25 revision of this document:
1. Added a patent statement and removed an expired patent statement.
2. Corrected text defining ICH in Section 1, Description.
3. Updated the Lumit trademark and a third party trademark.
4. Applied patent statements to Cat.# GA6020.
5. Updated text in Section 3 regarding the cell vial box label.

Revised 4/25.