drug discovery

Guidance Prepared On the Importance of Large & Small Molecule Bioanalysis for Drug Development

Both large and small molecule bioanalysis are techniques that are employed primarily in the pharmaceutical and food & beverage industry. These techniques find great use in the measurement of drug metabolites and other components. Depending on the size of the molecule, the effect of a specific metabolite can vary, which is why these two techniques are separately implemented as and when necessary. 

Next, we’ll cover some of the most essential techniques employed in small molecule bioanalysis for drug development.

While there are tons of laboratories that perform bioanalysis, there are some essential highlights that are to be followed according to a proper guidance system. Some of these include:

  • Extraction of protein precipitation
  • Duplication of standard curves
  • LC-MS or MS for sample analysis
  • Frequent turnaround times
  • Method qualification
  • Electronic data summary

While small and large molecule bioanalysis requires these techniques very often, public labs sometimes fall short to meet the demands. This is one of the reasons why Clinical Research Organizations have a momentous role to play in the pharmaceutical industry. Professional CROs have been adding value with their cutting edge research and drug development capabilities for major pharma players across key geographies. 

Why is this technique so crucial for drug discovery?

Drug discovery is one such aspect wherein there are umpteen rules and regulations for all the right reasons. This is why before a drug reaches clinical trials, it passes through multiple stages; like pharmacokinetic studies, pharmacodynamic studies, et cetera. 

The pharmacokinetic study is one such step wherein the various drug metabolites are identified, or very specifically small molecule bioanalysis is initialized at this step-through primary identification of the molecule. 

A prevalent method of identification is through the LC-MS assay, which is employed for small molecule bioanalysis. The aim here is to achieve maximum sensitivity without a direct reduction capacity of reproducibility. 

Biomarker discovery at this stage is supported through metabolomics, LC-MS, and ADMET, which are just some of the effective techniques. 

The workflow of the bioanalysis depending on the matrix

Both small and large molecule bioanalysis has some major protocols to follow, which depending on the model used for drug discovery, may change. Here’s a list of the most commonly observed method for this analysis:

For Blood plasma/Serum- 

For this matrix, the sample is prepared by BIO SPME method followed by derivatization through reagents. The chromatographic separation is generally carried out through Express UHPLC Columns, and the labware used for this includes vials. 

For drugs that are injected in tissues or cells- 

The sample collection of cells is carried out through Supel Select Polymeric HLB, and in the case of tissues, it uses the MALDI matrices. Chromatographic separation is carried out through Chiral HPLC for cells and HPLC Accessories for tissues. While syringes are used for cells, syringe filters are used for tissues. 

These are some of the commonly used guidance systems for small and large molecule bioanalysis in drug discovery. Most of the discussed approaches, equipment and techniques are generally employed for bioanalysis of small molecules while there are a few exceptions for large molecules. 

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