The Role of Bioanalysis

Bioanalysis forms part of a greater analytical chemical testing portfolio used to determine and describe the quantitative measurement of a drug or chemical as part of early drug development processes. This happens where detection of the levels of exposure and effects of the compound in given conditions is needed.

The process of bringing a new drug to market and passing the regulatory requirements required to ensure the drug’s safety in, around and on humans is critical. This process has traditionally been costly, leading to many drugs failing during the early developmental stages. Assay testing during the pre-clinical and clinical phases is essential to the safety measures designed to identify, reduce or manage the risks associated with newly developed drugs, chemicals and treatments. Any information or knowledge loss during the process is best overcome by selecting a bioanalytical services provider who can offer the complete battery of testing from pre-clinical to clinical and assist with meeting the demands of the regulatory bodies as you seek approval.

Alderley Analytical, experts in bioanalysis solutions, is a contract research organisation specialising in the services required to support clinical development through discovery, pre-clinical and clinical safety testing of small or large molecules, peptides and oligonucleotide test compounds.

Bioanalysis in action

Drug discovery programs must undertake quantitative studies on the role of drugs and their metabolites within biological fluids to identify chemicals’ pharmacokinetics and metabolic fate in living cells, within humans and animals. Rapid high-volume throughput testing to achieve reliable, lower-cost, economical test results using low volumes of test substances is making the process of bringing a new drug or chemical compound to market and gaining regulatory approval a more straightforward, more durable process, that helps pharmaceutical and chemical businesses achieve wider success in their product and treatment development. 

Bioanalysis of test compounds gives valuable data on the function of the drug to provide critical information required to meet the demands of the regulatory bodies. It is an intrinsic part of the determination of the efficacy and safety of drugs earlier in the development process so that institutions can make better-informed decisions on the way forward. Potentially harmful drugs can be identified in pre-clinical studies, and through modes of action and mechanism studies, researchers can determine their drug’s potential viability and future. Understanding the data provided is vital to making informed decisions on whether the drug or compound can be modified or whether positive results mean the project is no longer viable.

The bioanalytical methods must be validated to meet stringent Food and Drug Administration (FDA) and other regulatory requirements, and high-quality and accurate clinical testing data must fully underpin robust program decisions.  

Is Bioanalysis alone sufficient?

In the pre-clinical stage, bioanalysis should be considered part of the broader toxicology study; it is insufficient to consider it merely as a secondary measure to the in vivo phase. Bioanalysis testing regimes should form part of the early staged planning alongside in vivo, as this inter-dependency can influence the sampling process or the timing of appropriate biomarker data capture. 

Awareness and experience of a broad range of modalities and biologic development scenarios are just some of the benefits you can expect from an early collaboration with an outsourcing bio-analysis research organisation to offer many significant benefits to improve and accelerate the road to drug development that is needed. Many drugs have failed during evolution simply because of the time and money required to identify and study the drug’s effects on humans and the costs to do so. 

Bioanalysis is a key component of drug development and increasingly also includes analysis and in some cases identification of clinical biomarkers.  Bioanalysis and biomarker analysis together provide a broader picture of the therapeutic’s pharmacokinetic and pharmacodynamic profile which expedites the drug development process.