Drying technologies for biopharmaceutical applications: Recent developments and future direction
Drying technologies for biopharmaceutical applications: Recent developments and future direction
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DOI：
10.1080/07373937.2017.1355318
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发表时间：
2018-01-01
影响因子：
3.3
通讯作者：
Ohtake, Satoshi
中科院分区：
文献类型：
--
作者：
Langford, Alex;Bhatnagar, Bakul;Ohtake, Satoshi
干燥是生物治疗产品生产中常用的加工技术。除水有许多好处，包括易于处理和储存、降低运输成本和改善稳定性，仅举几例。通常，干燥是通过冷冻干燥完成的，市场上有几种冷冻干燥产品就证明了这一点。然而，冷冻干燥有几个缺点，包括干燥所需的过程时间长，能源效率低，以及购买和维护设备的高成本。此外，冷冻干燥是一个批处理过程，在连续生产工艺方案中适应和实施可能是具有挑战性的。这些局限性导致了对可应用于生物治疗产品制造的下一代干燥技术的探索。本文综述了几种可供选择的干燥方法，特别强调了每种技术与冷冻干燥相比的优点和缺点，以及每种方法用于生物治疗化合物干燥的潜力。
Drying is a commonly used processing technique for the manufacture of biotherapeutic products. Removal of water provides numerous benefits, including ease of handling and storage, reduction in transportation costs, and improved stability, to name a few. Typically, drying is accomplished through freeze-drying, as evidenced by the availability of several lyophilized products on the market. There are, however, several drawbacks to lyophilization, including the lengthy process time required for drying, low energy efficiency, and the high cost of purchasing and maintaining the equipment. Furthermore, lyophilization is a batch process and may be challenging to adapt and implement within a continuous manufacturing process scheme. These limitations have led to the search for next-generation drying technologies that can be applied to the manufacture of biotherapeutic products. Several alternative drying methods are reviewed herein with particular emphasis on the advantages and disadvantages of each technology in comparison to lyophilization and the potential of each to be utilized for drying biotherapeutic compounds.