Bioassay
The objective of bioassay is to determine the bioactivity and to analyze the mode of action of recombinant proteins.
Bioassay Services according to ICH Q6B
About Bioassay
Bioassays play one of the most important roles 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.
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.
Bioactivity
The bioactivity 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.
Our Bioassay Expertise
Our validation engineers, who are well-qualified, specializes in cell and molecular biology, allowing us to contribute to the design, development and validation of cell-based assay, potency assays, ADCC assay, assay for target validation and drug screening, to support marketing authorization and GMP release of samples.
Providing Bioassay Expertise
- Proficiency with cell and molecular biology
- Proficiency with multiparametric flow cytometry analyses (FACS)
- Proficiency with immunofluorescence analysis
- Proficiency with cell-based assay procedures and potency assays
- Proficiency with mammalian cell culture and laboratory technologies
- Proficiency with GMP requirements and regulations (FDA, EU)
- Proficiency with specifications according to ICH Q6B
Our Bioassay Services
- Design, development and validation of potency assays
- Design, development and validation of cell-based assays for drug screening and target validation
- Supporting testing for release and stability
- Statistical analysis of validation experiments
- Supporting scientific and laboratory assistance
Your Bioassay Benefits
- Contributing to validated bioassays
- Contributing to GMP release of samples
- Contributing to clinical trial and marketing authorization
