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Design and Commercialization of an End-to-End Continuous Pharmaceutical Production Process: A Pilot Plant Case Study

By Testa, Christopher J.; Hu, Chuntian; Shvedova, Khrystyna; Wu, Wei; Sayin, Ridade; Casati, Federica; Halkude, Bhakti S.; Hermant, Paul; Shen, Dongying Erin; Ramnath, Anjana; Su, Qinglin; Born, Stephen C.; Takizawa, Bayan; Chattopadhyay, Saptarshi; O'Connor, Thomas F.; Yang, Xiaochuan; Ramanujam, Sukumar; Mascia, Salvatore

Published on

Abstract

The pharmaceutical industry faces multiple challenges (e.g., inefficient manufacturing techniques, quality control issues, and supply chain vulnerabilities) because of its current batch-wise approach to manufacturing. Recent regulatory support for continuous manufacturing and advances in continuous process technologies have caused an increase in interest from some drug manufacturers to modernize their production processes. However, many of these companies have focused on hybrid processes, where only certain steps are continuous, while others remain batch. Herein, the quality by design (QbD)-based design strategy and operation of an end-to-end integrated continuous manufacturing (ICM) pilot plant that produces both small-molecule active pharmaceutical ingredient (API) and oral solid dosages (OSDs) are discussed. Additionally, important quality and economic matters pertaining to scale-up and commercialization are addressed. ICM has significant benefits, including better quality control, increased supply chain flexibility, a lower capital investment (in the example provided, a ∼ 90% reduction), and lower operating costs (in the example provided, a 33.6% reduction for API and 29.4% reduction for tablets).

Journal

Organic Process Research & Development. Volume 24, 2020, 2874-7889

DOI

10.1021/acs.oprd.0c00383

Type of publication

Peer-reviewed journal

Affiliations

  • Continuus Pharmaceuticals
  • IMA S.p.a
  • FDA / USV Private Limited (U.S. Food and Drug Administration / USV Private Limited)

Article Classification

Research article

Classification Areas

  • PAT
  • API

Tags