Automated mass characterization for early actionable insights

Many factors contribute to the outcome of an initial pharmaceutical clinical trial. The preclinical evaluation of a drug candidate’s safety and efficacy relies on several in vitro studies being performed, including cell-based potency, ADME-tox, and binding assay studies. These studies are crucial for understanding which candidates are worth sending to trial but time-consuming and labor-intensive. Obtaining actionable data on biotherapeutics earlier in development can allow for exclusion of bad candidates sooner and enable researchers to focus on more promising therapeutics. Achieving this requires the ability to make educated inferences about how drug candidates behave based on critical quality attributes such as mass characterizations.

The amount of data generated through studies evaluating drug characteristics—including potency, efficacy, consistent manufacturability, physical and chemical stability, and safety—is too vast for an individual scientist or team of scientists to analyze and make appropriate decisions on. Actionable data must be extracted from huge datasets spanning drug discovery and early development, a process that would take a team too long to be practical. The use of a mass spectroscopy-based analytics solution like Genedata Expressionist can provide a practical solution to this issue, with highly configurable application-specific data workflows reflecting the variability in structures and modalities of drug candidates. Automated analyses can dramatically increase throughput and improve standardization as well as reproducibility while allowing scientists to focus on the most crucial steps of the analyses performed. The resulting high-quality data enable better, faster, and more confident decision-making regarding a drug candidate’s behavior.

There is a need to compress drug discovery timelines and find novel biotherapeutics faster. Gaining an early and comprehensive molecular understanding of drug candidates is essential to expedite the drug discovery process and reduce attrition rates at later stages of drug development. At the Life Sciences companies of Danaher, we take a holistic approach to drug discovery and analytics to meet your throughput needs, automating and enhancing workflows to unlock productivity and improve quality. To learn more about our offerings or explore ways of partnering with us, contact an expert at the Life Sciences companies of Danaher today.