NDLI: Characterizing the Freeze–Drying Behavior of Model Protein Formulations

Content Provider	Springer Nature Link
Author	Lewis, Lavinia M. Johnson, Robert E. Oldroyd, Megan E. Ahmed, Saleem S. Joseph, Liji Saracovan, Ilie Sinha, Sandipan
Copyright Year	2010
Abstract	The freeze–drying behavior of three model proteins, namely, lysozyme, BSA, and IgG, has been studied using a variety of techniques under two different primary drying conditions (shelf temperatures of −25°C and +25°C, respectively) in an amorphous formulation. Manometric temperature measurements were used to characterize product temperature (T $_{pr}$), sublimation rates, and product resistance (R $_{p}$) during primary drying. Biophysical techniques such as circular dichroism, fluorescence, and Fourier transform infrared spectroscopy were used to study protein conformation. Size exclusion chromatography was used to monitor the formation of high-molecular-weight species (HMWS) over time on storage, and cake morphology was studied using scanning electron microscopy. The differences in the freeze–drying behavior of the three proteins were more evident at higher protein concentrations, where the protein significantly influences the behavior of the formulation matrix. However, these differences were minimized in the aggressive mode and were insignificant at lower protein concentrations where excipients dominated the freeze–drying behavior. Differences in cake morphology were observed between the two drying conditions employed as well as between the three proteins studied. The stability and the protein structure, however, were equivalent for the protein cakes generated using the two different primary drying conditions.
Starting Page	1580
Ending Page	1590
Page Count	11
File Format	PDF
Journal	AAPS PharmSciTech
Volume Number	11
Issue Number	4
e-ISSN	15309932
Language	English
Publisher	Springer US
Publisher Date	2010-11-06
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	freeze drying manometric temperature measurements micro-collapse product resistance proteins Pharmacy Biochemistry Biotechnology Pharmacology/Toxicology
Content Type	Text
Resource Type	Article

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