When it comes to the drug manufacturing industry Assay development plays a vital role in identifying and characterizing a new drug molecule. The need for assays was very crucial in biomedical research which has the ability to design, develop, and run assays that are very specific, sensitive, and robust. In the very basic research format, one needs to identify the level of proteins and their quantifying levels, determine how their metabolite level is present in their urine or serum. And also to identify the catalytic activity of the enzymes that are present in the normal tissue and the diseased one. Even identifying the stability of the molecule is also an important thing in stability studies a part in assay development.
What is measured here?
Initially, it needs to be clear about what the molecule is going to be tested and the property of the molecule should be measured. It is the first and foremost thing to consider when it comes to assay development activities. If a researcher wishes to measure the total availability of protein particularly in a cell lysate, this may even indicate the specific isoforms or the splice variants of the protein molecule which is inspected. If a person really wants to know about the key factor that makes or affects the biological functions such as the effect of a cytokine, enzymatic activities and etc.
Alternatively it may be acceptable or desirable to measure the level of gene expression at the mRNA level. In order to measure the gene level, separate assays have to be developed in order to check their protein l levels and their functions.
What is the source of the molecule?
Another important thing to be considered is the source of the molecule, where the source is extracted from either serum or urine. Where the molecule to be tested is extracted from either from a biopsy or from a particular human organ or from an animal or else even it can be obtained from the post martem tissue. The source of the molecule is essential in identifying the sample quality and the quantity of the sample available from the source. It is also used to determine the molecule of interest and also the stability of the component available.
Samples to be assayed:
It is also important to know the number of samples needs to be assayed. If only a few numbers of test need to be done that can be taken forward with the help of laboratories and the samples were tested in a step by step procedure. If they need to run more and more test then the time allocation has to be done and an automate assay process has to be scheduled to test the lump amount of samples.
It is important to understand the stability of the molecule for which the assay has to be developed. When it comes to assay development it is thoroughly segmented into each section and the stability studies are a part of it. If the molecule to be tested is stable then no problem if the molecule is extremely unstable hen the proper precautions have to be carried out.