title: Spray-drying performance of a bench-top spray dryer for protein aerosol powder preparation.
abstract: 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.
authors: Pharmaceutical Research and Development, Genntech, Inc., 1 DNA Way, South San Francisco, California 94080, USA. maa.yuh-fun@gene.com
authors: Y F
authors: YF
authors: Maa
authors: P A
authors: PA
authors: Nguyen
authors: K
authors: K
authors: Sit
authors: C C
authors: CC
authors: Hsu
mesh_terms: D000336:Aerosols; D000888:Antibodies, Anti-Idiotypic / Q000737:chemistry* / Q000648:ultrastructure; D000911:Antibodies, Monoclonal / Q000737:chemistry* / Q000648:ultrastructure; D003890:Desiccation / Q000295:instrumentation / Q000379:methods; D004867:Equipment Design; D005079:Excipients; D006801:Humans; D007073:Immunoglobulin E; D008855:Microscopy, Electron, Scanning; D011208:Powders; D011994:Recombinant Proteins / Q000737:chemistry / Q000648:ultrastructure
chemical_list: D000336:Aerosols; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D005079:Excipients; D011208:Powders; D011994:Recombinant Proteins; D007073:Immunoglobulin E