赋形剂
血凝素(流感)
抗原
流感疫苗
疫苗效力
病毒学
病毒
效力
化学
生物
免疫学
体外
接种疫苗
生物化学
色谱法
作者
Newton Wahome,John M. Hickey,David B. Volkin,C. Russell Middaugh
出处
期刊:Methods in molecular biology
日期:2016-01-01
卷期号:: 393-421
标识
DOI:10.1007/978-1-4939-3389-1_27
摘要
A critical element of vaccine formulation studies is the identification of chemical and physical degradation pathways that compromise structural integrity, and which may in turn affect the clinical safety and efficacy, of macromolecular antigens. Formulation development helps optimize and maintain the long-term storage stability and viability of vaccine antigens in pharmaceutically relevant dosage forms. The protocols presented in this manuscript highlight the use of accelerated stability studies for the formulation of influenza vaccine candidates including virus-like particles (VLP) and particle forming hemagglutinin (HA) antigens. Three case studies, each targeting a different facet of preclinical vaccine formulation development, are reviewed: (1) excipient screening experiments to mitigate VLP physical degradation, (2) methods for monitoring a specific chemical perturbation of the recombinant HA antigen and elucidating its effect on in vitro potency, and (3) maintaining HA conformational stability in the presence of freeze–thaw and freeze-drying stresses.
科研通智能强力驱动
Strongly Powered by AbleSci AI