This session will explore novel ways to reduce project time lines and demonstrate how PODular manufacturing will increase facility flexibility to meet potential future changing business needs. The presentation is directly applicable to flexible manufacturing facilities and responsiveness of drug supply.  It will address key lead time challenges in traditional manufacturing and offer an option for manufacturing closer to the customer.

Session Moderator 

Mark A. Butler – President and Managing Director, IPS

Genentech’s New Clinical Supply Center: A manufacturing template for future commercial facilities

Speaker: Doug Deveny

The presentation will explore many of the methodologies utilized and resulting design characteristics intended to achieve these goals over the lifecycle of the facility. A modular design approach, involving the creation and deployment of standard unit operation work cells, will be highlighted throughout the discussion, illustrating its impact on the facility configuration, construction techniques and project timelines, as well as the potential options and benefits expected to be realized on similar future next generation projects. In addition, progressive regulatory strategies, leveraging functionally-closed systems, have been integrated to reduce spatial segregations and area classifications, while minimizing the need for modifications to accommodate future process changes and technologies.

Transportable Manufacturing

Speakers: Maria Hoffman, Michael Becker, and Michael O’Brien

Supply chain end-to-end lead times are typically long, triggering decision-making prior to the actual customer demand signals. Demand can be highly variable and unpredictable, while the industry is often challenged with drug shortages. As political, regulatory, and market demand requirements evolve, one’s ability to respond appropriately and in a timely fashion is therefore undermined. Today’s manufacturing platforms and associated analytics are smaller, lighter, and significantly more modular versus their predecessors, enabling much smaller factory footprints, allowing for the realization of a transportable manufacturing platform and facilities concept. These flexible, transportable units can address variable demand through scale out (running the continuous process longer, or replication of the unit), and may be installed more quickly than traditional manufacturing site expansion. Consequently, when business needs change down the road, the manufacturing unit can be moved to another location. The potential financial, technical, and regulatory obstacles for the movability of a manufacturing environment will be addressed. Case studies will be presented that illustrate the benefits of mobility and the opportunities and challenges of operating a mobile facility.