2024 AIChE Annual Meeting

(550c) Path to Commercial Reality of Continuous Manufacturing - a Cdmo Perspective

Author

Continuous tableting (CT, defined as continuous manufacturing of oral dosage tablets) represents a paradigm shift in pharmaceutical manufacturing, promising increased efficiency, reduced costs, and accelerated pathways for drug approval. The end users of CT, and especially the CDMOs, play an important role in the adoption of this technology. However, there remain both tangible and perceived obstacles that must be addressed to facilitate widespread adoption.

This session will cover progress being made across multiple fronts and the roadmap towards commercial adoption of the technology.

Details will be provided on engaging with a complex operation involving a large team, challenging sampling procedures, and complex logistics in the process of launching continuous tableting GMP operations. Each step, from running the rig to changeover, presented unique and complex challenges necessitating innovative solutions. The transition from a team of experts to a proficient commercial operation run by operators will be highlighted. Additionally, the journey to a proficient commercial operation, with improved yields and reduced deviations, will be reviewed. The specific challenge of changeover will be discussed, with examples on how it was addressed through simulation modeling and shop-floor operational excellence approaches.

The economics of CT technology will be explored, with insights into its cost competitiveness with batch mode. Based on cost analysis, areas requiring attention will be discussed, such as team size, equipment costs, and maintenance.

The discussion will also highlight recent regulatory guidance and publications, exploring the trend towards accelerated pathways for drug approval, with continuous tableting emerging as a facilitator of acceleration. Realizing the benefits of CT in accelerating drug approval processes requires simplification and flexibility, aligning with regulatory expectations and industry standards.

Attention will be given to the development of simple and flexible CT standards, enabling new modes of operation and ultimately simplifying CT technology through the introduction of flexible rigs. The discussion will include details of the CDC Flex concept, which covers a range of line rates from low to high and encompassing both batch and continuous modes of operation.

Lastly, the session will include a discussion on the journey of CT from complexity to commercial reality, and the diverse opportunities for further simplification and advancement of the technology that result from Hovione's experience as early adopters in this field.