title: Freeze-drying of HESylated IFNα-2b: Effect of HESylation on storage stability in comparison to PEGylation.
abstract: A comparison of lyophilized PEGylated and HESylated IFNα was carried out to investigate the influence of protein conjugation, lyoprotectants as well as storage temperature on protein stability. Results show that PEG tends to crystallize during freeze-drying, reducing protein stability upon storage. In contrast, HESylation(®) drastically improved the stability over PEGylation by remaining totally amorphous during lyophilization, with and without lyoprotectants while providing a high glass transition temperature of the freeze-dried cakes.
authors.affiliation: Department of Pharmacy, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximillians-University Munich, Butenandtstr. 5-8, 81377 Munich, Germany. Electronic address: robert.liebner@cup.uni-muenchen.de.
authors.forename: Robert
authors.initials: R
authors.lastname: Liebner
authors.affiliation: Innovation Centre Complex Formulations, Fresenius Kabi Deutschland GmbH, Pfingstweide 53, 61169 Friedberg, Germany.
authors.forename: Sarah
authors.initials: S
authors.lastname: Bergmann
authors.affiliation: Innovation Centre Complex Formulations, Fresenius Kabi Deutschland GmbH, Pfingstweide 53, 61169 Friedberg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hey
authors.affiliation: Department of Pharmacy, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximillians-University Munich, Butenandtstr. 5-8, 81377 Munich, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Winter
authors.affiliation: Department of Pharmacy, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximillians-University Munich, Butenandtstr. 5-8, 81377 Munich, Germany.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Besheer
mesh_terms: D002152:Calorimetry, Differential Scanning; D003460:Crystallization; D004355:Drug Stability; D004356:Drug Storage; D005612:Freeze Drying; D006895:Hydroxyethyl Starch Derivatives / Q000737:chemistry*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000737:chemistry*; D011092:Polyethylene Glycols / Q000737:chemistry*; D055550:Protein Stability; D011994:Recombinant Proteins / Q000737:chemistry; D013696:Temperature; D044366:Transition Temperature
chemical_list: D006895:Hydroxyethyl Starch Derivatives; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols
keywords: Crystallization; Freeze-drying; HESylation; Interferon α-2b; PEGylation; Phase separation