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.
Enteric delivery of my API: How to make it right?
November 15th 2023The enteric delivery of pharmaceuticals has long been a challenge for numerous reasons, including protecting the active pharmaceutical ingredients (APIs) from the harsh environment of the gastrointestinal tract and assuring consistent delivery and dosage in the small intestine. This paper reviews the challenges and the science that shows Lonza’s proposed hard capsule solution has been validated to provide acid protection, customization, and scalability.