Facilitating Adoption of Continuous Manufacturing Platforms in the Pharmaceutical Industry

Abstract

Continuous manufacturing (CM) of pharmaceutical products has gained a great deal of interest over the past decade. CM promises multiple benefits to all pharmaceutical industry stakeholders; however, pharmaceutical manufacturers generally have been slow to invest in the technology and even slower to transition their manufacturing operations from batch even when a CM process would make the most sense. This thesis intends to drive the implementation of CM to augment batch manufacturing, allowing for a wider array of manufacturing tools in the pharmaceutical manufacturing enterprise by using a system-focused approach in developing a change system for small molecule pharmaceutical manufacturing, with the emergent property of an actionable framework based on systems architectural design that manufacturers can use. This research will employ the Architecting Innovative Enterprise Strategy (ARIES) Framework1 to illustrate the current and future landscapes of the pharmaceutical manufacturing enterprise. First, the problem space, specifically the environment that impacts the pharmaceutical manufacturing enterprise including stakeholders and governing agencies, will be described. Second, the envisioned future for the drug manufacturing enterprise in which the enterprise adopts CM as a dominant manufacturing process as opposed to solely batch manufacturing is examined. Finally, a framework is synthesized for the transition to CM in the pharmaceutical manufacturing enterprise derived from ARIES elements (strategy, process, organization, knowledge, products, services, information, infrastructure) nested in the previously described ecosystem and stakeholders. This framework will not be prescriptive, but also is intended to be adapted for each company’s unique business model and operational circumstances.