title: Stressed Stability Techniques for Adjuvant Formulations.
abstract: Stressed stability testing is crucial to the understanding of mechanisms of degradation and the effects of external stress factors on adjuvant stability. These studies vastly help the development of stability indicating tests and the selection of stabilizing conditions for long term storage. In this chapter, we provide detailed protocols for the execution of forced degradation experiments that evaluate the robustness of adjuvant formulations against thermal, mechanical, freeze-thawing, and photo stresses.
authors.affiliation: Bioprocess Research and Development, Sanofi Pasteur, 1755 Steeles Avenue West, Toronto, ON, Canada, M2R 3T4.
authors.forename: Manvi
authors.initials: M
authors.lastname: Hasija
authors.affiliation: Bioprocess Research and Development, Sanofi Pasteur, 1755 Steeles Avenue West, Toronto, ON, Canada, M2R 3T4.
authors.forename: Anthony
authors.initials: A
authors.lastname: Sheung
authors.affiliation: Bioprocess Research and Development, Sanofi Pasteur, 1755 Steeles Avenue West, Toronto, ON, Canada, M2R 3T4.
authors.forename: Nausheen
authors.initials: N
authors.lastname: Rahman
authors.affiliation: Bioprocess Research and Development, Sanofi Pasteur, 1755 Steeles Avenue West, Toronto, ON, Canada, M2R 3T4. fernando.ausar@sanofipasteur.com.
authors.forename: Salvador F
authors.initials: SF
authors.lastname: Ausar
mesh_terms: D000276:Adjuvants, Immunologic / Q000737:chemistry*; D004339:Drug Compounding / Q000379:methods*; D004355:Drug Stability
chemical_list: D000276:Adjuvants, Immunologic
keywords: Forced degradation; Freeze-thawing; Mechanical stress; Photostability; Thermostability