Innovative Drying Technologies for Biopharmaceuticals

Sharma, Ashutosh and Khamar, Dikshitkumar and Cullen, Sean and Hayden, Ambrose and Hughes, Helen (2021) Innovative Drying Technologies for Biopharmaceuticals. International Journal of Pharmaceutics, 609. ISSN 0378-5173

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Abstract

In the past two decades, biopharmaceuticals have been a breakthrough in improving the quality of lives of patients with various cancers, autoimmune, genetic disorders etc. With the growing demand of biopharmaceuticals, the need for reducing manufacturing costs is essential without compromising on the safety, quality, and efficacy of products. Batch Freeze-drying is the primary commercial means of manufacturing solid biopharmaceuticals. However, Freeze-drying is an economically unfriendly means of production with long production cycles, high energy consumption and heavy capital investment, resulting in high overall costs. This review compiles some potential, innovative drying technologies that have not gained popularity for manufacturing parenteral biopharmaceuticals. Some of these technologies such as Spin-freeze-drying, Spray-drying, Lynfinity® Technology etc. offer a paradigm shift towards continuous manufacturing, whereas PRINT® Technology and MicroglassificationTM allow controlled dry particle characteristics. Also, some of these drying technologies can be easily scaled-up with reduced requirement for different validation processes. The inclusion of Process Analytical Technology (PAT) and offline characterization techniques in tandem can provide additional information on the Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) during biopharmaceutical processing. These processing technologies can be envisaged to increase the manufacturing capacity for biopharmaceutical products at reduced costs.

Item Type:	Article
Additional Information:	Funding Information: The authors acknowledge funding received from Waterford Institute of Technology – Sanofi Waterford Co-fund PhD Scholarship Program (Ashutosh Sharma) and the Irish Research Council – Enterprise Partnership Scheme (Project ID: EPSPG/2020/56). The authors also acknowledge Robert Turok at SPX Flow Inc. for his valuable suggestions on spray-drying in the manuscript. Funding Information: The authors acknowledge funding received from Waterford Institute of Technology ? Sanofi Waterford Co-fund PhD Scholarship Program (Ashutosh Sharma) and the Irish Research Council ? Enterprise Partnership Scheme (Project ID: EPSPG/2020/56). The authors also acknowledge Robert Turok at SPX Flow Inc. for his valuable suggestions on spray-drying in the manuscript. Publisher Copyright: © 2021 The Author(s)
Uncontrolled Keywords:	/dk/atira/pure/subjectarea/asjc/3000/3003
Departments or Groups:
Depositing User:	Admin SSL
Date Deposited:	19 Oct 2022 23:04
Last Modified:	16 Aug 2023 03:25
URI:	http://repository-testing.wit.ie/id/eprint/3899

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