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12 Pharmaceutical Technology ® Trends in Formulation eBook September 2024 PharmTech.com TRIOCEAN – STOCK.ADOBE.COM A n essential factor to consider when develop- ing a robust continuous manufacturing (CM) process is the impact that inherent excipient and API physicochemical variations can have on the drug product performance, CM unit operations, or CM process as a whole. This paper examines the key information needed for excipients and their potential impact on CM pro- cesses. Much of this information is derived from sev- eral presentations made at a Product Quality Research Institute (PQRI) workshop entitled, "Managing Excip- ient and API Impact on Continuous Manufacturing", held virtually on May 17–18, 2022 (1). CM involves continuous feeding of input materi- als into, the transformation of in-process materials within, and the concomitant removal of output mate- rials from an interconnected manufacturing process in which two or more-unit operations are directly in- tegrated. While many excipients have been continu- ously manufactured for decades, the use for pharma- ceutical drug products, particularly oral solid dosage (OSD) forms, is relatively new. Knowing how excipient physicochemical properties impact CM, whether as a whole or in individual unit operations, needs to be understood to implement a rigorous control strategy and ensure a robust CM process. Not every excipient will have a direct impact on the overall process but may affect individual unit operations to some degree. Most regulatory guidelines apply only to APIs and drug product manufacture but not excipients (e.g., International Council for Harmonisation [ICH] Q13 [2]). However, regulators and other organizations are discussing what impact excipients may have on CM and what controls or understanding are needed to Key information is needed for excipients and their potential impact on continuous manufacturing processes. Krizia M. Karry, Brian Carlin, Nigel Langley, R. Christian Moreton, David R. Schoneker, Katherine L. Ulman, and Joseph Zeleznik Understanding Excipient Characteristics to Ensure Robust Continuous Manufacturing