When it comes to analyzing large numbers of samples, it is a common misconception that the quality of instrumentation and facility are enough to ensure accurate, consistent results. This may be true for analysis of small molecule drugs, which have simple, stable, well-defined structures and little ability to initiate immune responses. However, the characteristics of large molecule drugs are very different, with numerous intricacies that can impact bioanalytical results.
Consider the disparity in levels of complexity alone: aspirin, a typical small molecule drug, has 21 atoms; whereas a large molecule biologic like an IgE antibody has 25,000 atoms. That’s akin to comparing the complexity of a 20-pound bicycle to a 30,000-pound business jet.
Another element of simplicity for small molecule drugs is that they have the advantage of being produced through a well-defined chemical synthesis process. By contrast, large molecule drugs are difficult to completely characterize because they are produced in living cell culture, making them more complex and sensitive to external conditions, with a tendency to be immunogenic. Even slight inherent differences may produce marked dissimilarities in efficacy, safety, and immunogenicity—which can have a major impact on how the the biologic is clinically managed.
Because of these complexities, we feel strongly that large molecule sample analysis still requires the oversight of an experienced team of scientists. It is vital that the CRO partner performing your sample analysis has extensive first-hand expertise working with large molecule drugs, is well-versed in their complexities, and has proven success overcoming their bioanalytical challenges for accurate, reliable results.
This need is made even more critical when conducting analysis for a large number of samples, where small errors can compromise significant amounts of data. Your project should be supported with expertise commensurate with the level of difficulty of the biologic analysis, and scaled appropriately for the amount of sample analysis your study demands.
How BioAgilytix Handles Sample Analysis
The philosophy behind our approach to large molecule sample analysis is simple: every project is a priority, and deserves our most experienced scientific minds. Sample analysis findings are as critical to the success of your study as any other data gathered in the drug development process, so those projects are assigned a team with strong experience and training in conducting analysis of biologics in a number of sample matrices.
This team is led by a Bioanalytical Project Manager (BPM), a scientist with extensive experience in large molecule bioanalysis. Your BPM provides an interface between our scientific team and your own internal scientists to maintain continuity, accountability, and ownership throughout the project – and to deliver high-quality results on time.
Throughout the project, our team will leverage the appropriate technology from our extensive suite of bioanalytical platforms to perform analysis. Our state-of-the-art instrumentation enables us to efficiently manage large numbers of samples by facilitating high throughput and strong data reproducibility. We have first-hand experience with the unique capabilities and strengths of each platform, and will help select the right-fit technology for your specific sample profiles and analysis requirements.
As you can see, there are a number of reasons why large molecule sample analysis requires a proven bioanalytical lab partner. The complexity inherent in biological drug development should not be overlooked at any phase, including sample analysis when conducted at scale. It is important to ensure you have experts overseeing these processes to head off potential challenges before they become costly issues.
If you’d like to learn more about our capacity and capabilities for large molecule sample analysis, I would be happy to describe our differentiated approach in more detail. Drop me a line today!