Role of assay development in testing drug safety and efficacy

Building safe and effective drugs start with the creation of robust and precise assays An assay is an analysis carried out to ascertain the occurrence of a substance and its quantity. 

In a pharmaceutical industry assays ohelp identify and characterise the potential molecules in a new drug. During the process of assay development, it is important that attention is paid to the entire workflow required to be developed right from the sample preparation stage to the data analysis in order to get valid data.

It helps determine the pharmacological or biological potency of a drug. For instance, an assay could be developed to determine the potency of a vaccine.

What is Assay Development?

Assay Development is the measuring or testing the activity of a biochemical or a drug in an organic sample or an organism. 

Assays measure: 

  • Enzyme activity
  • Antigen capture
  • Stem cell activity
  • Competitive protein-binding etc

What does an assay investigate?

It is a procedure that qualitatively assesses or quantitatively measures the presence, quantity, or functional activity of a particular entity, which is the analyte. 

How do Assay development and validation help in testing drug safety and efficacy?

Assay development forms one of the very first steps in the process of drug development and toxicity testing. It evaluates the chemical compound effect on cellular, molecular, or biochemical processes of interest. Such probes could also become therapeutic candidates in drug development.

Bioanalytical assays help in determining the implications of design, its limitations, favorable conditions as well as the suitability of a drug for the anticipated treatment. Before the initiation of assay development and validation, it is essential to understand the analyte’s physiochemical properties. 

Bioanalytical assays are vital to drug discovery and development due to the following aspects. 

  • Their ability to discern the following
    • Purity
    • Identity
    • Potency 
    • Performance

All these factors are crucial to the safety of the drug for the potential treatment.

  • The techniques allow reliable and reproducible quantification of analytes in different biological matrices such as:
    • Plasma
    • Urine
    • Blood
    • Serum
  • Assay development and validation analyses the drugs, biomarkers, and metabolites. This is done to make sure that the test results achieved are specific and accurate. This data is robust and supports the drug development process to improve drug efficacy.¬†
  • Different method characteristics play a vital role during every assay development and validation stage. These include:¬†
    • Precise analyte chemistry¬†
    • Sample clean-up for methodology analysis
    • Desired method sensitivity¬†
  • The main assay development and validation purpose is to get the most appropriate method for the chosen analyte in a particular biological matrix.¬†
  • Assay validation is important because the outcome of the analysis might be erroneous otherwise and will be deemed unreliable.¬†

The importance of assay development and validation requires it to be carried out with the most suitable technology so as to ensure that the necessary compliance with the scientific and regulatory parameters can be achieved. Developing top-quality assays is fundamental to the process of drug discovery and development. Superior quality assays mean fewer potential problems in the later stages of the development process.