Maa Y F, Nguyen P A, Sit K, Hsu C C
Pharmaceutical Research and Development, Genntech, Inc., 1 DNA Way, South San Francisco, California 94080, USA.
Biotechnol Bioeng. 1998 Nov 5;60(3):301-9.
The objective of this work was to improve a bench-top spray dryer's efficiency in both production recovery and throughput for preparing protein aerosol powders. A Büchi mini-spray dryer was used to prepare the powders of recombinant humanized anti-IgE antibody. The resulting powder's physical properties such as particle size, residual moisture, and morphology, along with its recovery and production rate was the basis of this development work. Mass balance suggests that approximately 10-20% of powder was lost in the exhaust air, consisting primarily of particles less than 2 micrometer. Also, significant loss (20-30%) occurred in the cyclone. Attempts were made to improve product recovery in the receiving vessel using dual-cyclone configurations, different cyclone designs, cyclones with anti-static treatment, and different receiver designs. System modifications such as replacing the original bag-filter unit with a vacuum system effectively reduced drying air flow resistance, allowing the protein to be dried at a lower inlet air temperature and the production scale to be increased. We concluded that the modified spray-drying system is advantageous over the original bench-top spray dryer. This improvement will be beneficial to early-stage research and development involving high-valued protein powders.
这项工作的目标是提高台式喷雾干燥机在制备蛋白质气溶胶粉末时的生产回收率和产量效率。使用Büchi小型喷雾干燥机来制备重组人源化抗IgE抗体粉末。所得粉末的物理性质，如粒径、残留水分和形态，以及其回收率和生产率是这项开发工作的基础。质量平衡表明，约10%-20%的粉末在废气中损失，主要由小于2微米的颗粒组成。此外，旋风分离器中也发生了显著损失（20%-30%）。尝试使用双旋风分离器配置、不同的旋风分离器设计、经过抗静电处理的旋风分离器以及不同的接收器设计来提高接收容器中的产品回收率。通过用真空系统替换原来的袋式过滤器单元等系统改进措施，有效降低了干燥气流阻力，使蛋白质能够在较低的进气温度下干燥，并提高了生产规模。我们得出结论，改进后的喷雾干燥系统比原来的台式喷雾干燥机更具优势。这一改进将有利于涉及高价值蛋白质粉末的早期研发工作。
