v-IMG_4830 Test your product on live cells

In an ideal world you would conduct clinical trials to see if your new drug is working, but these can be costly and there are often ethical issues to consider. So how do you know if a drug is working if you can’t test it on humans?

Many of our clients turn to cell-based assays, which are basically experiments on a small number of live cells. By monitoring the number and behaviour of the cells, they offer the potential for dynamic observation.

We excel in this area because we have a talented and experienced cell-based assay specialist that has worked with us for many years. You can rest assured that your experiments are being overseen with the highest level of quality control in mind. And our team can complete the complicated procedure in as quickly as six to eight weeks.

Compared to ELISA, cell-based assays are very complex but they give better results and are far more thorough. We use a simplified version of the organism you’re trying to treat, but retain the complicated live cells and metabolism of the original organism.

Cell-based assays are commonly applied by our clients during the drug development phases of characterization of a biological product, lot release or stability testing.

Technical information

Cell-based assays are commonly designed around a specific biological drug and its particular mode of action (MoA).

We optimize the routine cell culture by creating master and working cell banks for each cell line. Several assay responses are possible, including cell proliferation, cell killing (cytotoxicity), differentiation, cytokine/mediator secretion (receptor activation) or enzyme activation. We determine the specific activity of proteins like monoclonal antibodies, cytokines, hormones and growth factors.

By using cell lines that respond to the specific MoA, cell-based assays can determine the relative potency of a biological product in relation to a reference standard material. Potency assays provide assurance of the quality and consistency of the product.

We determine the relative potency of your drug by comparing it to a Test to Standard assay response. For the data evaluation, specific software such as PLA2.0 can be used to fulfil all the statistical requirements.

Cell-based assays are often carried out according to PharmEu. Assay transfer, establishment and optimization as well as validation of existing assay formats is performed in close collaboration with you. The assays can be set up to be GMP-compliant to ICH Q6B or, alternatively, under non-regulatory conditions of the highest quality standards.

Note that biological activity (receptor ligand interactions) can also be determined with an ELISA. Furthermore, cell-based assays can be coupled with an ELISA as readout.

Your contact for Cell-based Assays at Protagen Protein Services GmbH

Marcus-Mreyen

Dr Marcus Mreyen

Director Business Development
Our business development team will be happy to assist you with your project.

Phone: +49 (0) 231 9742-6100
Email: salesproteinservices@ProtagenProteinServices.com