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Monitoring and Control of Product Temperature Using Thermal Imaging During Continuous Freeze-Drying Process of Unit Dose Formulations - Aug 2019

ライフィクスアナリティカル

In recent years, the pharmaceutical industry has rapidly advanced the development of biopharmaceuticals such as therapeutic proteins and vaccines. These drugs face challenges regarding stability in aqueous solution, which is why freeze-drying has become an essential technology for long-term storage. Traditional freeze-drying is conducted in a batch process that handles multiple vials at once, resulting in long processing times and high costs. Furthermore, controlling the freezing process is difficult, leading to variations in ice crystal size among vials, which causes inconsistencies in drying rates and poses challenges for ensuring product quality uniformity. Additionally, the heat distribution within the drying chamber is uneven, raising concerns about the risk of product collapse and quality variability. To address these issues, a new manufacturing technology called "continuous freeze-drying" has emerged in recent years. This technology combines continuous supply of raw materials with continuous discharge of products, achieving shorter processing times, cost reductions, and smaller equipment. Moreover, it reduces quality differences between vials, allowing for the efficient production of uniform and stable products. This groundbreaking technology has been further commercialized by RheaVita since its introduction in 2019, and in March 2025, a GMP-compliant system was implemented at their headquarters in Belgium.