Challenges faced by the modern bioanalytical laboratory have grown along with its greater role in drug development. At face value, the requirements from a bio lab often seem contradictory. For example, the lab must provide services at low-cost while maintaining high-quality and fast turnaround rates. All of this, while complying with stringent legal and regulatory requirements.
Many of these challenges lean towards the administrative side of things. However, there are also a significant number of challenges with bioanalysis and the processes involved.
Proper method development is a key requirement for bioanalytics. The focus goes to faster method development using robust methods. This is generally a way to save time and thus move the process along faster. At the same time, the speed of faster and more robust methods needs to conform to producing more sensitive methods. Additionally, the method should be capable of working with lower sample volumes.
Sample preparation should also consider the isolation and quantification of test analytes. The biological matrix is often a complex mix of various components. This can lead to interference and distortion of the results. Proper separation of the test analyte, working with low sample volumes, and better separation efficiency are necessary. Possible sample clean-up has to be considered as it can affect and cascade through subsequent samples of a batch.
The introduction and use of SPE and LC-Ms help with several aspects, but the process remains challenging.
Proper assay development and validation can require both time and effort. The requirement for fast-turnaround times for bioanalysis puts pressure on the process. Sample preparation for an assay has to deal with reducing interference from the biological matrix. Additionally, the assay should conform to various requirements, including robustness and reproducibility.
A robust assay is a great way to reduce time requirements. However, care must be taken not to sacrifice attributes like selectivity and sensitivity in choosing the assay. Often, this requirement can be contradictory. Generally, a biolab will also focus on the reproducibility of the assay.
Selectively capturing analytes of interest and bringing increased reproducibility to the assay is important. In some cases, it is desirable to reproduce well-to-well, going all the way to year-to-year.
In some cases, regulation may be unable to keep pace with the development and best-possible use of assays. For example, regulators may require the use of cell-based assays, whereas a laboratory may find plate-based assays to be more robust, inexpensive, and efficient.
Monetary and time limitations are a very big part of the challenges faced by any bio lab. Faster, cheaper, and better is the holy grail of any industry. It is way more important in the case of a bioanalytical laboratory. Efficiency requires faster method development, spending less time per sample, and needing less instrument time to produce data.
Requirements like assay validation, incurred sample reanalysis (ISR), metabolites in safety testing (MIST), and compliance must also be satisfied. All of this should ideally be achieved at low-cost, and where relevant, high throughput.
Automation processes are available but often have major limitations. Laboratories often end up taking the route of semi-automating the process to achieve better results, rather than using full automation.
Setting up efficient communication with the sponsor and other stakeholders is another challenge that should not be overlooked. Most sponsors often see communication as an important deciding factor shaping their opinion of a bioanalytical laboratory.
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