title: Design and application of a low-temperature Peltier-cooling microscope stage.
abstract: A light microscopy system has been designed for freezing and lyophilization studies of protein pharmaceuticals. The system consists of a cascade of four Peltier thermoelectric modules in the lyophilization cell to freeze samples to -60 degrees C, controllers to regulate temperature and pressure conditions, and a video camera to record the events under study. Specific demonstration of the system was conducted using recombinant CD4-IgG and human growth hormone (hGH) as model proteins. Observations of recrystallization during warming of frozen CD4-IgG solution and lyophilization of hGH solution are discussed. These examples demonstrate that the system is a useful tool for the fundamental understanding of freezing and lyophilization of protein pharmaceuticals.
authors.affiliation: Department of Pharmaceutical Research, Genentech, Inc., South San Francisco, CA 94080, USA.
authors.forename: C C
authors.initials: CC
authors.lastname: Hsu
authors.forename: A J
authors.initials: AJ
authors.lastname: Walsh
authors.forename: H M
authors.initials: HM
authors.lastname: Nguyen
authors.forename: D E
authors.initials: DE
authors.lastname: Overcashier
authors.forename: H
authors.initials: H
authors.lastname: Koning-Bastiaan
authors.forename: R C
authors.initials: RC
authors.lastname: Bailey
authors.forename: S L
authors.initials: SL
authors.lastname: Nail
mesh_terms: D015704:CD4 Antigens / Q000737:chemistry; D003080:Cold Temperature; D005612:Freeze Drying / Q000295:instrumentation*; D005615:Freezing; D013006:Growth Hormone / Q000737:chemistry; D006801:Humans; D007074:Immunoglobulin G / Q000737:chemistry; D008027:Light; D008853:Microscopy / Q000295:instrumentation*; D011994:Recombinant Proteins / Q000737:chemistry; D012996:Solutions
chemical_list: D015704:CD4 Antigens; D007074:Immunoglobulin G; D011994:Recombinant Proteins; D012996:Solutions; D013006:Growth Hormone