2023 - Drug Product Development: Challenges and Strategies for High-Potent and Low-Dosed Products

The landscape of drug development is constantly evolving, presenting pharmaceutical companies with unique challenges that demand innovative solutions. Among others, critical areas that require special attention are highly potent active pharmaceutical ingredients (HPAPI) and handling of micro-dosed APIs at the same time. The webinar explores the challenges, and the measures drug developers and manufacturers must adopt to effectively handle HPAPIs, as well as solid dosage form technologies that allow for handling low-dosed APIs.
HPAPI handling stands out as a paramount concern in the current research and development (R&D) pipeline, accounting for a significant 50 percent of the projects. These potent APIs often exhibit remarkable efficacy even at extremely low doses. Consequently, drug product development companies must adopt a comprehensive approach to address the complexities that arise from HPAPI handling. This holistic concept revolves around three pillars: production equipment, processes and people.
Implementing specific concepts for shared facilities and establishing highly flexible setups become crucial factors for the fast and efficient development of drug products. These tailored approaches allow for quicker adaptation to the unique requirements of each HPAPI, ensuring safety, and maintaining high productivity levels.
In conclusion, drug developers must be proactive in their approach to adapt to the current challenges in the R&D pipeline. By effectively handling HPAPIs, devising targeted therapy solutions and employing advanced formulation technologies, they can pave the way for successful drug development in the future.
Join this webinar to get insights into the challenges and strategies in drug product development and manufacturing and the safe and flexible handling of HPAPIs.