Research Topic

Freeze-Drying and Process Analytical Technology for Pharmaceuticals

About this Research Topic

Freeze-drying is a key step in pharmaceutical manufacturing due to the higher stability of drugs in a solid state than in a liquid solution. Therefore, the number of products requiring freeze-drying in the production process is increasing exponentially: in 2016, 50% of novel drugs approved by the Food and Drug Administration (FDA) were biopharmaceuticals, and approximately 50% of the approved biopharmaceutical drugs on the list of the FDA and the European Medicines Agency (EMA) are freeze-dried.
Within this framework, according to the “Guidance for Industry: Process Analytical Technology (PAT)” issued by the FDA in 2004, a true quality-by-design manufacturing principle, rather than the classical quality-by-testing approach, should be implemented in order to obtain safe, effective, and affordable medicines. This requires the development of suitable Process Analytical Technologies to monitor and control product quality in-line, focusing also on the physicochemical properties of freeze-dried formulations.
This Research Topic aims to show the most recent advancements in the field of freeze-drying monitoring and control, and in the characterization of freeze-dried products, as well as in the application of these technologies to freeze-drying food.


Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

Freeze-drying is a key step in pharmaceutical manufacturing due to the higher stability of drugs in a solid state than in a liquid solution. Therefore, the number of products requiring freeze-drying in the production process is increasing exponentially: in 2016, 50% of novel drugs approved by the Food and Drug Administration (FDA) were biopharmaceuticals, and approximately 50% of the approved biopharmaceutical drugs on the list of the FDA and the European Medicines Agency (EMA) are freeze-dried.
Within this framework, according to the “Guidance for Industry: Process Analytical Technology (PAT)” issued by the FDA in 2004, a true quality-by-design manufacturing principle, rather than the classical quality-by-testing approach, should be implemented in order to obtain safe, effective, and affordable medicines. This requires the development of suitable Process Analytical Technologies to monitor and control product quality in-line, focusing also on the physicochemical properties of freeze-dried formulations.
This Research Topic aims to show the most recent advancements in the field of freeze-drying monitoring and control, and in the characterization of freeze-dried products, as well as in the application of these technologies to freeze-drying food.


Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

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Submission Deadlines

31 January 2018 Abstract
20 April 2018 Manuscript

Participating Journals

Manuscripts can be submitted to this Research Topic via the following journals:

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Topic Editors

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Submission Deadlines

31 January 2018 Abstract
20 April 2018 Manuscript

Participating Journals

Manuscripts can be submitted to this Research Topic via the following journals:

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