Giovanni Aprile, Peter Sagmeister, Cedric Devos, Aniket Udepurkar, Francesco Destro, Fateme Molajafari, Torsten Stelzer, Hamza Youssef Ismail, Daniel J. Griffin, Richard D. Braatz and Allan S. Myerson*,
{"title":"Automation in Pharmaceutical Crystallization","authors":"Giovanni Aprile, Peter Sagmeister, Cedric Devos, Aniket Udepurkar, Francesco Destro, Fateme Molajafari, Torsten Stelzer, Hamza Youssef Ismail, Daniel J. Griffin, Richard D. Braatz and Allan S. Myerson*, ","doi":"10.1021/acs.oprd.6c00057","DOIUrl":null,"url":null,"abstract":"<p >Crystallization is a key unit operation in the pharmaceutical industry for separation, purification, solid-form selection, and particle design. Yet, developing robust crystallization processes can be resource-intensive, since thermodynamics and kinetics both govern system behavior, resulting in numerous process parameters that must be optimized. Automation offers a powerful means to accelerate this development, but the very complexity that makes crystallization challenging─nonlinear responses, multiphase behavior, and a large design space, among other factors─also complicates automation. This review discusses how automation technologies are applied for resource-efficient crystallization process development, focusing on their contributions to the core process development activities: design space mapping, modeling, process control, optimization, and scale-up. Many automation tools─ranging from process analytical technology hardware to algorithmic experiment-selection and control software─are already widely used in crystallization, but typically in isolation. This review focuses on automation tools for pharmaceutical crystallization, emphasizing their role in accelerating process understanding, improving resource efficiency, enabling reproducible data generation, and supporting intelligent decision-making.</p>","PeriodicalId":55,"journal":{"name":"Organic Process Research & Development","volume":"30 7","pages":"1746–1780"},"PeriodicalIF":3.3000,"publicationDate":"2026-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Organic Process Research & Development","FirstCategoryId":"92","ListUrlMain":"https://pubs.acs.org/doi/10.1021/acs.oprd.6c00057","RegionNum":3,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/6/25 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"CHEMISTRY, APPLIED","Score":null,"Total":0}
引用次数: 0
Abstract
Crystallization is a key unit operation in the pharmaceutical industry for separation, purification, solid-form selection, and particle design. Yet, developing robust crystallization processes can be resource-intensive, since thermodynamics and kinetics both govern system behavior, resulting in numerous process parameters that must be optimized. Automation offers a powerful means to accelerate this development, but the very complexity that makes crystallization challenging─nonlinear responses, multiphase behavior, and a large design space, among other factors─also complicates automation. This review discusses how automation technologies are applied for resource-efficient crystallization process development, focusing on their contributions to the core process development activities: design space mapping, modeling, process control, optimization, and scale-up. Many automation tools─ranging from process analytical technology hardware to algorithmic experiment-selection and control software─are already widely used in crystallization, but typically in isolation. This review focuses on automation tools for pharmaceutical crystallization, emphasizing their role in accelerating process understanding, improving resource efficiency, enabling reproducible data generation, and supporting intelligent decision-making.
期刊介绍：
The journal Organic Process Research & Development serves as a communication tool between industrial chemists and chemists working in universities and research institutes. As such, it reports original work from the broad field of industrial process chemistry but also presents academic results that are relevant, or potentially relevant, to industrial applications. Process chemistry is the science that enables the safe, environmentally benign and ultimately economical manufacturing of organic compounds that are required in larger amounts to help address the needs of society. Consequently, the Journal encompasses every aspect of organic chemistry, including all aspects of catalysis, synthetic methodology development and synthetic strategy exploration, but also includes aspects from analytical and solid-state chemistry and chemical engineering, such as work-up tools，process safety, or flow-chemistry. The goal of development and optimization of chemical reactions and processes is their transfer to a larger scale; original work describing such studies and the actual implementation on scale is highly relevant to the journal. However, studies on new developments from either industry, research institutes or academia that have not yet been demonstrated on scale, but where an industrial utility can be expected and where the study has addressed important prerequisites for a scale-up and has given confidence into the reliability and practicality of the chemistry, also serve the mission of OPR&D as a communication tool between the different contributors to the field.
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