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.
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.