From Data to Discovery: Harnessing AI/ML, Advancing Drug Development

During drug development, researchers need to uncover reliable, actionable insights and articulate critical factors that affect the quality of a product or a process. One powerful technique to achieve this is Design of Experiments (DoE)—a systematic approach that explores the relationship between variables to optimize process and ensure product quality. Identifying and focusing on key variables, like process parameters, can help researchers create reliable workflows that ensure consistent critical quality attributes and scalable production.

Digital solutions can optimize individual processes within the drug development pipeline, but they often fail to provide a complete perspective for identifying the most critical parameters of the drug development process. With the need for automated data collection and increased collaboration, data is often stored in multiple locations or spreadsheets, increasing the risk of data loss or misinterpretation. Streamlining data management and analysis can help biopharma and biotechnology professionals derive insights for drug development more efficiently and accurately.

Cloud-based software platforms equipped with strong data infrastructure are needed to help researchers design and scale better experiments. These platforms can empower researchers with advanced tools for collection, management and sharing of product and process data. They should ensure complete access to comprehensive datasets and enable standardized data analysis across workflows. In the future, AI/ML capabilities will also help scientists leverage existing data to design future process workflows and predict outcomes accurately, saving both time and resources. Continuous process verification will safeguard data integrity and help to reduce the risk of errors and ensure compliance with stringent regulatory requirements.

Navigating through multiple stages of drug development, including cell line development, bioreactor management, and downstream processing can be daunting for researchers. Digitized workflow management and advanced data interpretation can help companies accelerate their product lifecycles, ultimately bringing therapies to patients faster. To learn more about our solutions or explore ways of partnering with us, contact an expert at the Life Science companies of Danaher today.