Bioanalytical method development plays a vital role in the drug development process helping to detect and quantify the levels of drugs and metabolites in biological systems (or matrices).
In bioanalytical terms, method development is the creation of the analytical process for identifying and quantifying known components present in a biological sample matrix. Analyte components are measured by several methods, and it involves many considerations, such as chemical properties of the analyte, concentration levels, sample matrix, cost of the analysis, speed of the analysis, and quantitative or qualitative measurement.
The role of a bioanalytical method development is to produce accurate, precise methods that work every time for our analysts. The process of method development includes sampling, sample preparation, separation, detection, and evaluation of the results.1 Achieving a perfect method each time would be ideal, but we know that it may not always be possible.
At Arcinova, A Quotient Sciences Company is to focus on producing good quality methods that analysts can quickly deploy, no matter the study size—whether for a short, preclinical study of a hundred samples or a major clinical study of twenty thousand—enabling us to do our part in helping get molecules to patients faster.
When developing bioanalytical methods, we can either transfer methods in from an outside laboratory—the quickest route—or produce them from scratch—a harder process because there isn’t a preexisting method to work from. Creating a method from scratch allows our team to use our skills more freely and deploy innovative techniques or new equipment, often leading to a better-quality method or faster analyses.
We believe that a good method developer needs to have a solid scientific skillset, with a strong interest in analytical technology and techniques, and a certain ability to be painstaking. While a lot of the work is solitary—pipetting standards, tuning the system, and running samples—it is equally important to be a team player. We need to effectively communicate our progress to the Study Director and the client. We also need to check in with other colleagues when needed for scientific advice or support.
In the end, we must also support the analysts as they begin to run the method, because often even the best methods develop issues that simply were not seen in development, such as a matrix effect for example.
If a customer requires a new method, we ask to review and discuss the compound structure, Certificate of Analysis for the material, sample matrix, level of validation required, and any requirement around detection limits (otherwise, our standard limit of quantitation is 1 ng/mL in plasma.) We'll also need to know if a method has to be ready for a specific study start date, for planning purposes.
Whatever the method, whether elemental or a protein, and whatever the matrix, we apply the same basic workflow and steps to the project, to ensure everything has gone through the same steps, and by doing so, we are more likely to generate a robust method. Our major output, or piece de resistance, is the Bioanalytical Specification document, or BAS, which is the full working method and contains all essential data for reproducing the method.
We also provide our clients with summary documentation that outlines the key features and decision points for the method. So far, we have produced over 400 bioanalytical methods, in an array of sample matrices. The most common matrix is plasma for circulating active drugs; frequently, we look at tissues for compounds and particularly elemental analysis, and sometimes feces.
Learn more: Bioanalysis services from Arcinova
Our bioanalytical team has over 40 years of experience in supporting all stages of drug development, from early pre-clinical through to first-in-human and subsequent patient trials. Our focus is helping our customers get life-changing medicines to patients quickly and efficiently. Get more information about our bioanalytical capabilities.
References
1. Kirthi A, Shanmugam R, Shanti Prathyusha M, Jamal Basha D. A Review on bioanalytical method development and validation by RP – HPLC. 2014;5(4):2265-2271.2.