title: Practical Approaches to Forced Degradation Studies of Vaccines.
abstract: During the early stages of vaccine development, forced degradation studies are conducted to provide information about the degradation properties of vaccine formulations. In addition to supporting the development of analytical methods for the detection of degradation products, these stress studies are used to identify optimal long-term storage conditions and are part of the regulatory requirements for the submission of stability data. In this chapter, we provide detailed methods for forced degradation analysis under thermal, light, and mechanical stress conditions.
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: Sepideh
authors.initials: S
authors.lastname: Aboutorabian
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: D002626:Chemistry, Pharmaceutical; D004355:Drug Stability; D010782:Photolysis; D011506:Proteins / Q000737:chemistry; D013314:Stress, Mechanical; D013696:Temperature; D014612:Vaccines / Q000737:chemistry*
chemical_list: D011506:Proteins; D014612:Vaccines
keywords: degradation pathways; formulation; photo-degradation; stability; stress testing; thermal degradation