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<p>Freeze-drying has been a workhorse for the pharmaceutical industry to enable long-term storage and long-distance transport of drug products that are unstable in liquid or frozen form. The importance of freeze-drying was particularly evident in the development and storage of life-saving medicines such as mRNA-based vaccines during the COVID-19 pandemic. In response to growing demand for improved manufacturing efficiency, emerging freeze-drying technologies spurred by the U.S. Food and Drug Administration (FDA) Pharmaceutical Quality for the 21st Century Initiative have been introduced with the aim to modernize the pharmaceutical manufacturing sector. Here, we provide regulatory considerations for emerging technologies in pharmaceutical freeze-drying from a manufacturing perspective. We also present an analysis of current trends in freeze-drying and in-process controls submitted in human drug applications—24 New Drug Applications, 118 Abbreviated New Drug Applications, and 20 Biologics License Applications assessed between 2020 and 2023—seeking FDA approval. Additionally, we analyzed the Form FDA-483 Inspection Observations educed from 201 inspections conducted at manufacturing facilities performing freeze-dried parenteral operations between 2015 and 2019, to identify common compliance challenges and provide regulatory insights for the pharmaceutical industry.</p>

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Recent trends in pharmaceutical freeze-drying and control strategies observed in human drug applications and manufacturing inspections

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月1日

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  • Steve Y. Rhieu,
  • Maxwell Korang-Yeboah,
  • David D. Anderson,
  • John Arigo,
  • Thomas O’Connor,
  • Rakhi Shah

摘要

Freeze-drying has been a workhorse for the pharmaceutical industry to enable long-term storage and long-distance transport of drug products that are unstable in liquid or frozen form. The importance of freeze-drying was particularly evident in the development and storage of life-saving medicines such as mRNA-based vaccines during the COVID-19 pandemic. In response to growing demand for improved manufacturing efficiency, emerging freeze-drying technologies spurred by the U.S. Food and Drug Administration (FDA) Pharmaceutical Quality for the 21st Century Initiative have been introduced with the aim to modernize the pharmaceutical manufacturing sector. Here, we provide regulatory considerations for emerging technologies in pharmaceutical freeze-drying from a manufacturing perspective. We also present an analysis of current trends in freeze-drying and in-process controls submitted in human drug applications—24 New Drug Applications, 118 Abbreviated New Drug Applications, and 20 Biologics License Applications assessed between 2020 and 2023—seeking FDA approval. Additionally, we analyzed the Form FDA-483 Inspection Observations educed from 201 inspections conducted at manufacturing facilities performing freeze-dried parenteral operations between 2015 and 2019, to identify common compliance challenges and provide regulatory insights for the pharmaceutical industry.