Addressing Practical Challenges in CM via Novel Hardware and Automation

This work tackles critical operational challenges in continuous manufacturing processes for oral drug products, focusing on scalability, automation, and efficiency. Key issues include the complexity and manual nature of residence time distribution (RTD) experiments, non-automated execution of multi-point design of experiments (DOEs), and throughput limitations tied to existing continuous manufacturing equipment for oral solids. Innovative hardware and automation-based solutions have been developed to address the aforementioned challenges.

Key learnings of the session:

• Participants will learn of automated, novel approaches to execute residence time distribution experiments in CM process trains.
• Participants will learn of automated, novel approaches to execute DOEs in CM process trains, coupled with automated sampling with the goal of one-person DOE execution.
• Participants will learn of a novel approach that combines batch and continuous processing in a single process train and how built-in modularity enables the operation over a wide throughput range.