Bioassays

Bioassays are an integral part of the overall quality strategy for bio-pharmaceutical products.

Protagen AG provides the following assays:

• Cell based bioassays, e.g. proliferation, cytotoxicity
• ELISA
• Unique bioassay platform for therapeutic antibodies based on Protein Microarrays

For these assays, Protagen AG offers in close collaboration with its clients:

• GMP and non GMP analysis under highest quality standards
• Transfer and establishing of existing assays
• Optimization of bioassays using
  • Design of experiments (DOE)
  • Protein Microarrays for selection of specific detection antibodies
• Assay validation according to ICH Q2 (R1) and USP
• Batch release, stability and comparability testing

Protagen uniquely combines bioassays with structural and functional protein analysis: 

• well accepted analytical techniques (HPLC, PAGE etc) and
• sophisticated mass spectrometry
• modern quality management techniques like risk assessment

This portfolio is completed by profound expertise in bioinformatic data analysis and statistics.

Please This e-mail address is being protected from spambots. You need JavaScript enabled to view it  Protagen for further information.