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Recent Developments in the Crystallization Process: Toward the Pharmaceutical Industry

By Gao, Zhenguo; Gong, Junbo; Rohani, Sohrab; Wang, Jingkang

Published on

Abstract

Crystallization is one of the oldest separation and purification unit operations, and has recently contributed to significant improvements in producing higher-value products with specific properties and in building efficient manufacturing processes. In this paper, we review recent developments in crystal engineering and crystallization process design and control in the pharmaceutical industry. We systematically summarize recent methods for understanding and developing new types of crystals such as co-crystals, polymorphs, and solvates, and include several milestones such as the launch of the first co-crystal drug, Entresto (Novartis), and the continuous manufacture of Orkambi (Vertex). Conventional batch and continuous processes, which are becoming increasingly mature, are being coupled with various control strategies and the recently developed crystallizers are thus adapting to the needs of the pharmaceutical industry. The development of crystallization process design and control has led to the appearance of several new and innovative crystallizer geometries for continuous operation and improved performance. This paper also reviews major recent progress in the area of process analytical technology.

Journal

Engineering. Volume 3, 2017, 343-353

DOI

10.1016/J.eng.2017.03.022

Type of publication

Peer-reviewed journal

Affiliations

  • The University of Western Ontario
  • Tianjin University

Article Classification

Review article

Classification Areas

  • PAT
  • API

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