While the entire drug development process has evolved tremendously over time, bioanalytics—the foundation of drug development— remains labor-intensive and technically challenging. Despite recent advances involving the combination of traditional and new technologies, there is an urgent need for novel approaches in bioanalytics to increase throughput and improve drug development quality. To that end, the pharma community has employed new types of technologies and tools—traditionally used in a clinical laboratory—setting, such as the use of MesoScale devices and flow cytometry. As a well-established tool for biomarker analysis, flow cytometry has shifted from its origins in the clinical diagnostic laboratories to the regulated bioanalytical laboratory. Beyond whole-cell analysis for drugs such as CAR-T cells medicines, flow cytometry has applications in assisted biomarker and ADA testing.
That being said, the pressure to accelerate critical tasks, such as data transformation, analysis, and follow-on decision-making, continually expands in all phases of drug development. For example, within early clinical-stage bioanalysis, data review for large reports ideally requires 14 days to account for the multi-layered input involving stakeholders spanning bioanalytical scientists, management, quality control, and quality assurance. AI is well-positioned to handle not only the high volumes of bioanalytical data but also manage the complexity of the rules that must be applied to link and contextualize disparate data in key functions of assay development and sample analysis.
Today, pharma manufacturers are seeking analytical testing service providers to look for quality in terms of technical performance—the quality of the data and work performed—as well as with respect to regulatory compliance. Bioanalytical service providers have a deep understanding of the drug development process and extensive knowledge of regulatory requirements, combined with the ability and willingness to provide customized support. Hence, they are often viewed as real added value.
At this juncture, there are a wide variety of bioanalytical service providers in the pharma industry offering innovative services that further the drug development cycle. To help organizations navigate through the best-of-breed companies, Pharma Tech Outlook has compiled a list of leading bioanalytical services firms that are at the top of their game. The enlisted organizations are transforming the drug development process at the convergence of several disruptive technologies. Besides, the magazine also comprises insights from thought leaders in the sector on the industry trends, best practices, recent innovations, and their advice for aspiring CIOs.
We present to you Pharma Tech Outlook’s “Top 10 Bioanalytical Services Companies – 2020.”