• How Early Data Drives Better Cell Line Performance

    In the race to bring new biologics to market, development teams are constantly balancing speed, quality, and regulatory expectations. Yet one factor often determines long-term success more than any other: the strength of the data generated in the earliest phases of cell line development. read more
  • Engaging with Regulators for Single-Arm Oncology Research Trials

    When well-planned and well-executed, single-arm trials can accelerate access to life-saving therapies that might otherwise never reach desperate cancer patients. read more
  • HPLC-Based Strategies for Impurity Profiling and Validation in Standard Drug Analysis

    The control of pharmaceutical impurities is a fundamental objective in the development of drugs, focusing on the comprehension of the chemical structures of unidentified impurities. This understanding is essential for evaluating toxicological consequences and grasping the mechanisms of formation. API-related impurities, such as degradation and interaction, can affect drug product quality, safety, and efficacy. Classifying sources of impurities is essential for analytical method development and acceptance criteria. read more
  • Limitations of Existing Life Science Software - and the Opportunity to Evolve

    ELNs, LIMS and SDMS systems aren’t going away anytime soon. They provide a foundation for doing reliable, collaborative, and impactful science. The key here is that by embracing and adopting new technologies, scientific organizations can protect their existing investments while unlocking new levels of efficiency, collaboration, and discovery - at their own pace and on their own terms. read more