Quantics can help ensure that your bioassay validation study follows the appropriate regulatory guidance in all its statistical aspects, both design and analysis.

Our expert team of world-leading statisticians are well-equipped to assist with the design and analysis of any bioassay validation study. We can help you determine critical bioassay validation parameters including:

  • Relative Bias (Accuracy)
  • Intermediate Precision (Precision)
  • Assay Range
  • Specificity
  • Dilutional Linearity
  • Robustness
  • & More

We know that bioassay validation can be complicated, which is why we pride ourselves on clear and regular communication with our clients, both to determine client needs and to discuss results and next steps.

Image credit: https://www.usp.org/

Validation of Bioassays

Bioassay validation is the process of demonstrating and documenting that the performance characteristics of the procedure and its underlying method meet the requirements for the intended application and that the assay is thereby suitable for its intended use.

Read our blog about upcoming updates to USP <1033>

Get in Touch!

Need bioequivalence statistics? Use the form below to book a 30 Minute discovery call with our Customer Experience Manager, Andy Rust (andy.rust@quantics.co.uk).

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Follow our Bioassay Blog!

Jan 28

USP <1033>: The Goals of Bioassay Validation

One can think of the life of a bioassay in two main acts. First comes the design and development of the assay, where the assay method is conceptualised, refined, and optimised. Later, the goal is for the assay to be deployed in a regulated environment to, for example, test... read more →
Jan 14

The Challenges of Correlation: SPC for Bioassay Data

One common use for bioassays is to test manufactured biologic products before they are released to the wider consumer market. While all bioassays used for this purpose will have undergone stringent testing and validation, it is vital that their ongoing performance is closely monitored to ensure that any changes... read more →
Dec 10

Biosimilars: Are Comparative Efficacy Studies Required?

It is far from a controversial statement that biologic therapeutics – such as monoclonal antibody and recombinant protein therapies – are complex and expensive to develop. As one might expect, therefore, the results of that development are also expensive when provided to patients, with per-patient annual costs for some... read more →