METHOD VALIDATION

Bioassay play a major role as part 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 their complex nature of biopharmaceuticals and their complex process of manufacture, bioassays are one of the most challenging parts of your quality control strategy. 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.

Its bioactivity is depending on the overall shape of the protein which ist 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 sound dexterity and hands-on experience with the development and validation of cell-based potency assays our bioengineers are looking forward to supporting your cell culture experiments, fit to supporting marketing authorization and GMP release of samples.