Executive Summary: End-To-End Regulatory CDMO Solutions: Development, Manufacturing, and Approval
July 25th 2025The road to market access is long and complex. Choosing a CDMO with experienced staff can prove vital to success. In this executive summary, Praveenkumar Devakadaksham and Dr. Roché Marcel Walliser explain all the ways they help make the journey from pharmaceutical development to commercial distribution as smooth as possible. Learn more about:
Flexible-Dose Development Strategies for Today's Clinical Landscape - Executive Summary
January 8th 2025This executive summary focuses on dose-flexible manufacturing strategies and their role in drug development. Dose flexibility is increasingly important for early clinical studies, particularly in areas such as pediatric medicines and oncology. However, flexible dosing strategies are often neglected or not prioritized early in development. This presentation will focus on technical strategies that can help anticipate appropriate timing for implementation and how to do so cost effectively while adhering to required timelines.
Risk-Based Development Supporting Process Qualification for Spray-Dried Dispersion
November 13th 2024Spray drying enables the production of amorphous solid dispersions, allowing efficient scale-up from small screening batches to commercial levels. By leveraging small-scale experiments for process design and qualification, a robust validation strategy can be developed to support flexible, scalable manufacturing for small-molecule drug products.
Science of Scale for Spray-Dried Intermediates (July 2024)
July 24th 2024Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up-or scale-down-can play a key part in that process. Significant interest has been focused on the science of scale for spray drying, since this process is the leading technology for formulating drugs with slow dissolution rates or poor solubility, which results in low bioavailability. Lonza has over 20 years of experience in the scale-up and scale-down of spray drying processes. To learn more, read our executive summary.