Quality means doing it right

Are you ready to look at the quality control aspects of your product?

Before releasing a new drug on the market, you’ll need to show whether your protein is ‘working’ or not. Bioassays (or biological assays) measure the effects, such as potency, of your new drug on a cell model.

Successful bioassays require teamwork by a range of specialists. This is because of the complexity of the biomarkers that must be looked at. Our team, which includes a cell-based assay expert and protein chemists, has worked well together for a long time to make our bioassays a success every time.

And because we have our own in-house bioinformatics team, there are no delays when it comes to analysing outputs quickly and accurately.

We set up and carry out highly robust and reliable, GMP-compliant tests for a wide range of cell-based and ligand binding assays. We understand that bioassays are an integral part of quality assessment during the development and manufacture of biological drugs.

Ultimately, bioassays allow us to analyse structure-function relationships in your proteins. Many of our other protein characterization services look at a protein’s structure but bioassays look at its function. This is important because while all the right structural features might be present, your protein might not ‘work’ for functional reasons, such as incorrect folding.

We offer you a method portfolio which combines the analysis of both protein structure and functionality.

You can choose from the following bioassay services:

• An ELISA, which is useful when looking at quality control features such as drug purification, lot release and stability testing.
• Cell-based assays, which are used to determine the potency of a biological product and to monitor specific biological activity.
• Specific enzyme activity assays, which determine the functionality of enzymes.

Too determine protein quantity, we find the extinction coefficient of your sample and combine it with amino acid analysis, as recommended by ICH Q6B.

Your contact for Bioassay at Protagen AG

Dr Katja Aschermann Head of Business Development Protein Services. Her team will be happy to assist you with your project. Phone: +49 (0) 231 9742-6300 Email: salesproteinservices@protagen.de