Bioassay
The objective of bioassays is to determine the bioactivity and to analyze the mode of action of medicinal products.
Do you happen to know the regulatory GMP requirements in bioactivity testing?
About Bioassays
Bioassays play an important role in the product characterization of biological products according to ICH Q6B
The objective of bioassays is to analyze the biological activity of a biological or biotechnologically-derived medicinal products and to determine its mode of action.
Bioassay Validation
Bioassay validation is a mandatory and major regulatory GMP requirement for batch release and submission for manufacturing authorization and clinical trial studies.
The objective of bioassay validation is to verify that the assay is fit for the intended use. The purpose for performing the bioassay must be distinctly specified, e.g. batch release of drug substance (active pharmaceutical ingredient) or drug product; stability; comparability; etc. The GMP requirements are stated in the ICH Q6B Quality Guideline.
Bioassay Validation Services
United States Pharmacopeia (USP)
- Validation Services according to USP Chapter <1032>: Design and Development of Biological Assays
- Validation Services according to USP Chapter<1033>: Biological Assay Validation
Bioactivity Testing
The assessment of the biological activity is part of the characterization profile as described in ICH Q6B. 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.
Statistical Analysis
Dose-response curve
In some bioassays, a linear response model can be applied, for statistical analysis, to quantitatively determine the analyte.
However, the data type of the bioassay model to analyze the cellular response, follows in most cases a sigmoidal dose-response curve.
The dose-response curve represents a graphical illustration of the analyte (x-values) and the biological effect (y-values).
Four-parameter logistic regression model
The four-parameter logistic regression model is quite useful for the statistical analysis of cell-based assays for dose-response analysis.
It is a sigmoidal-shaped, nonlinear regression model used to quantify the analyte.
Four parameters (minimum asymptote, maximum asymptote, inflection point (EC50), and Hill coefficient) define the validation characteristics of the test performance in which the inflection point reflects the EC50 value.
EC50
The EC50 value defines the half-maximal effective concentration of the analyte. The EC50 value is used to determine the potency of proteins.
Key Benefits
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.
GMP Compliance
Compliance with Good Manufacturing Practice (GMP) states that medicinal products must be manufactured under specified quality standards. Compliance with GMP is a mandatory regulatory GMP requirement for all medicinal products to obtain the manufacturing authorization.
Compliance with GMP aims to ensure that the product, the manufacturing process, and the manufacturing facilities meet applicable requirements to ensure the continued safety, purity and potency of the product.
A potency assay is required due to the complexity and heterogeneity of biologicals and biotechnological-derived medicinal products.
Key Expertise
- Proficiency with cell and molecular biology
- Proficiency with florescence activated cell sorting (FACS)
- Proficiency with immunofluorescence analysis
- Proficiency with cell-based assay procedures and potency assays
- Proficiency with mammalian cell culture
- Proficiency with regulatory GMP requirements (FDA, EMA, EU)
- Proficiency with specifications for biological products according to ICH Q6B
Our Bioassay Services
- Design and Development of Biological Assays (USP <1032>)
- Biological Assay Validation (USP <1033>)
- Potency assays
- Cell-based assays for drug screening and target validation
- Assisting testing for release
- Statistical analysis of validation experiments
- Scientific and laboratory assistance
Your Bioassay Benefits
- Contributing to validated bioassays
- Contributing to GMP release of samples
- Contributing to clinical trial and marketing authorization
