(273a) Modular Flexible Manufacturing - Enabling and Accelerating Specialty Product Development and Commercialization

The “traditional” pharmaceutical product development and commercialization paradigm involves formulation development (and early phase clinical supply manufacture) carried out at a development site, followed by commercialization, and launch, at a separate commercial site. In this scenario both sites feature equipment associated with common drug product manufacturing unit operations (e.g., powder conveying, blending, roller compaction, tableting, etc., in the case of oral solid dose formulations). Commercialization typically consists of the tech transfer and scale-up from the development to the commercial equipment train.

This approach fits the pipelines of the past, which were dominated by large-volume, small-molecule, orally delivered drug products. A future state characterized by small-volume, targeted therapies, based on a diversity of modalities, formulation types and delivery routes, however, will likely necessitate the redesign of the development and commercialization paradigm as well.

This talk will present the concept of a network of flexible and versatile sites capable of rapidly tech transferring and commercializing any set of unit operations through the use of self-contained, mobile, autonomous manufacturing units (PODs). The implementation of the concept will be demonstrated using the example of an implantable, long-lasting parenteral product – a formulation requiring non-typical equipment and manufacturing space requirements – without an installed commercial manufacturing base, and without a following pipeline.