title: Storage and Lyophilization of Pure Proteins.
abstract: This article outlines empirical procedures for the storage of pure proteins with preservation of high levels of biological activity. It describes simple and workable means of preventing microbial contamination and proteolytic degradation, and the use of various types of stabilizing additives. It sets out the principles of lyophilization (otherwise known as freeze-drying, a complex process comprising freezing, primary dying, and secondary drying stages). There follows a general procedure for the use of lyophilizer apparatus with emphasis on best practice and on pitfalls to avoid. The use of modulated differential scanning calorimetry to measure the glass transition temperature, a key parameter in the design and successful operation of lyophilization processes, is described.
authors.affiliation: School of Biotechnology, Dublin City University, Glasnevin, Dublin 9, Ireland. ciaran.fagan@dcu.ie.|National Centre for Sensor Research, Dublin City University, Glasnevin, Dublin 9, Ireland. ciaran.fagan@dcu.ie.
authors.forename: Ciarán
authors.initials: C
authors.lastname: Ó'Fágáin
authors.affiliation: Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Ireland.
authors.forename: Keith
authors.initials: K
authors.lastname: Colliton
mesh_terms: D004356:Drug Storage / Q000379:methods / Q000592:standards; D005612:Freeze Drying / Q000295:instrumentation / Q000379:methods*; D010084:Oxidation-Reduction; D055550:Protein Stability; D011506:Proteins / Q000737:chemistry*; D059748:Proteolysis
chemical_list: D011506:Proteins
keywords: Excipients; Freeze-drying; Freezing; Lyophilization; Modulated differential scanning calorimetry; Protein stability; Stabilizing additives; Storage of pure proteins