As molecules become more complex and the pressure to deliver advanceable First-in-Human formulations increases, a smart, material-sparing approach to CMC development becomes essential.
To truly support accelerated timelines, a scaled-down technique must do more than enable basic formulation screening. It should generate representative test materials and provide meaningful insights for process scale-up and manufacturing risk assessments.
The role of bench-scale techniques minimizing material usage is constantly evolving in pragmatic pharmaceutical product development, but for a truly effective strategy, and integrated approach for technology selection, enabled intermediates, and advanceable and patient-centric drug product must be considered.
In this presentation we introduce the concept of a comprehensive approach for material-sparing product development for complex, yet patient-centric, formulations. Through several case studies, we highlight how bench-scale approaches can be leveraged in CMC development to not only guide formulation selection, but to produce representative test articles that support the early establishment of in vitro - in vivo comparisons, accelerated predictive stability studies, and analytical method development.
Furthermore, we consider how the data generated in these scaled-down models can be leveraged for efficient and material-sparing process scale-up to ensure a robust and reproducible manufacturing process for the first-in-human clinical trial materials and beyond.
In this webinar you’ll learn:
- Material-sparing strategies are essential for accelerating CMC development, especially for complex molecules and First-in-Human formulations
- Bench-scale techniques must do more than screen formulations—they should produce representative test articles that inform scale-up and de-risk manufacturing
- An integrated approach combining technology selection, enabled intermediates, and patient-centric design ensures that early development decisions support long-term product advancement
- Data from scaled-down models can drive predictive insights, supporting in vitro–in vivo correlation, stability assessment, and analytical method development
- Leveraging bench-scale data for process scale-up enables efficient, reproducible, and robust manufacturing—minimizing material use while maintaining quality and speed to clinic
Who should attend:
- CMC Leads
- Formulation Scientists
- Research Scientists