Bioassay Services according to ICH Q6B

Bioassays play one of the most important role within the context of product characterization and specifications. They are mandatory and major regulatory requirements as part of submission for regulatory approval and to support clinical trial studies. The objective is to determine the bioactivity and to analyze the mode of action of the recombinant proteins.

Due to the complexity of biopharmaceuticals and their complex manufacturing process, bioassays are one of the most challenging parts of your quality control program. Heterogeneity is a key issue and impact the product quality in terms of batch-to-batch consistency. Given these circumstances the determination of the biological activity belongs to one of the most challenging analyses.

The bioactivity itself is depending on the overall shape of the protein which is laid out by the amino acid sequence. How the protein is folded determines its function. Subtle changes in the protein structure can alter its bioactivity. Glycosylation is one of the most commonly known post-translation modifications. Consistency in assays is mandatory for validation experiments and statistical analysis. Therefore, skilled, experienced and trained technicians are essential and challenging within your work environment.

With 20+ years of dexterity and hands-on experience with the design, development and validation of cell-based potency assays, our bioengineers look forward to supporting your cell-based assays procedures, fit to supporting marketing authorization and GMP release of samples.