Efficient and agile process development and manufacturing for clinical supplies requires that certain lab and scale-up facility infrastructure and process flexibility concepts be utilized. The facility layout and design features provide the tools needed by the development team and can play an important role in the success of a process development campaign. In this work, we will review details of two recent facility upgrades at AbbVieâs API Pilot Plant and Process R&D Laboratories that help to achieve efficient continuous processing. Case studies of continuous processing setups will be presented to demonstrate how the facility infrastructure lends itself to a more optimized and agile process development campaign.
All authors are employees of AbbVie and may own AbbVie stock. The design, study conduct, and financial support for this research were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication.