Human Pgp Vesicle Kit with FluoPgp Substrate (HEK293 derived) | Fluorescence Pgp Assay | 100 Reactions

Is the FluoPgp fluorescence assay accepted by FDA and EMA for DDI submissions?

Yes — regulatory acceptance of a vesicular transport assay depends on the demonstrated ATP/AMP transport ratio (>5), appropriate positive and negative controls, and validated assay conditions, not on the detection method. Fluorescence data from a validated vesicular transport assay using FluoPgp, with the required control materials included in this kit, meets the evidentiary standard for DDI submissions under FDA DDI Guidance (2020) and EMA DDI Guideline (2013/2022). The lot-specific QC report and data sheet supplied with every kit document the ATP/AMP ratio and assay performance required for regulatory packages.

What is the FluoPgp substrate, and how does it differ from standard radiolabelled P-gp substrates?

FluoPgp is a proprietary Cell4Pharma fluorescent probe substrate that is transported by P-glycoprotein (ABCB1) in an ATP-dependent manner. It functions identically to classical radiolabelled P-gp substrates such as [³H]-vinblastine or [³H]-digoxin in the vesicular transport assay — ATP-dependent accumulation in vesicles is quantified and compared between ATP and AMP conditions. The difference is detection only: FluoPgp fluorescence is read directly on a standard plate reader, eliminating the need for a scintillation counter, LC-MS/MS system, radiolabelled compound handling, and radioactive waste disposal. Assay throughput and data quality are equivalent to radiolabel-based formats.

Can the FluoPgp substrate be used with existing P-gp vesicles from another source?

The FluoPgp substrate is supplied as an integrated component of this combined kit and is validated specifically against the Cell4Pharma P-gp vesicle preparation. Compatibility with vesicles from other sources has not been tested and cannot be guaranteed. If you already have Cell4Pharma P-gp vesicles and wish to add FluoPgp fluorescence capability to an existing workflow, please contact us to discuss options. For new projects starting from scratch, the combined P-gp + FluoPgp Kit provides the simplest and most fully validated path to fluorescence-based P-gp DDI data.

When should the standard Human P-gp Vesicle Kit be used instead of the FluoPgp kit?

The standard Human P-gp Vesicle Kit (without FluoPgp) is preferred when radiolabel or LC-MS/MS detection is already established in the laboratory and preferred for your regulatory submission package, when the test compound is fluorescent and would interfere with the FluoPgp fluorescence signal, or when an existing validated SOP specifies a non-fluorescence detection method. For all other cases — including high-throughput screening, early-phase profiling, and laboratories without radiolabel infrastructure — the FluoPgp kit offers a simpler and faster route to the same regulatory-grade P-gp transport data.

What documentation is supplied with the Human P-gp + FluoPgp Vesicle Kit?

Every kit shipment includes a lot-specific QC report confirming the ATP/AMP transport ratio (>5) with the FluoPgp substrate, and a data sheet with recommended assay conditions, FluoPgp concentrations, and reference inhibitor controls (e.g. elacridar / GF120918, verapamil). All Cell4Pharma kits are manufactured under ISO 9001 and ISO 13485 certified quality systems. Batch reservation for up to 36 months is available on request, ensuring lot-to-lot consistency in the FluoPgp substrate and vesicle preparation across extended screening campaigns.