Bioanalytical methods are crucial for all phases of drug development. A robust bioanalytical assay increases the success of drug discovery and development processes. Besides, the safety and efficacy of drug products largely depend on bioanalytical method development and validation. However, several aspects of bioanalytical methods need to be followed thoroughly. Often, researchers need to pay more attention to these requirements during bioanalytical method validation processes. Hence the current article highlights the top five considerations every bioanalytical testing services and assay development company should know when narrowing down these parameters.
Identify specification limits
For release testing, bioanalytical testing companies must determine the specification limits that control the release process. Assay development companies may set the specification limits using industry standards or historical data, statistical k sigma limits, and transfer functions or tolerance levels. However, the set limits must reflect the associated risks, control technical requirements and comply with quality assurance.
Risk assessment includes identifying steps and areas that may influence the accuracy, precision, selectivity, linearity, and signal-to-noise ratio. Researchers must focus on identifying the areas that need assay characterization and development.
Researchers can use several risk assessment methods, such as failure mode effects analysis. Besides the traditional approach of failure mode effects analysis, researchers should also consider probability and detectability, severity, and uncertainty of the risk factors and influence on CQA during risk assessment.
Researchers must plan the assay development and characterization approach based on the risk assessment profile. Here, determining the sampling method and size are crucial considerations. Moreover, the assay development phase can be divided into three steps; system design, tolerance design, and parameter design. During system design, researchers must ensure that the proper materials, chemistry, equipment, and technology are available for assay development. On the other hand, parameter design focuses on the design of experiments to ensure correct parameters produce optimal design set points. Also, adequate care must be taken when characterizing the design space for accuracy and precision.
After developing and validating a bioanalytical assay, researchers must have a well-defined control strategy. The following are some crucial aspects every researcher must know for a precise control strategy.
- Materials and reagents used for controls
- Stable standards
- Assessing true assay variation over time
- Materials used for correcting assay drift
- Transferring controls among laboratories.
Assay method validation and transfer
Researchers can use several measures of assay performance during assay method validation. These measures include impurities, the activity of API, and the amount of API. Moreover, they must organize the validation plan and have a clear picture of all requirements. Besides, representative drug products and drug substance materials should be clearly defined during assay method validation. This assurance helps in the accurate calculation and validation of limits of quantitation and detection.
Acceptance criteria must be appropriately defined and achieved. Moreover, researchers must perform assay method validation using the correct sampling size and bioanalytical testing protocol.. Finally, researchers must ensure that the bioanalytical method is fit for the intended purpose and transferable to both internal and external organizations.