Webinar - Material Sparing Approaches to Rapid Development and Scale-Up of Complex Drug Products

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.

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