Development of a Stable Liquid Formulation for Live Attenuated Influenza Vaccine.

Abstract:

:Live attenuated influenza vaccine (LAIV) is considered one of the most effective vaccines and can be manufactured quickly and inexpensively to counter seasonal or pandemic influenza. Lyophilization is widely used in vaccine production. However, it requires a longer production cycle and large-scale equipment, thus posing a considerable financial burden for developing countries. A potential solution is the development of liquid LAIV, which can increase the yield and reduce the cost of production. In this study, influential factors of LAIV, such as potential stabilizing excipients and pH, were optimized by an orthogonal design. We found that pH is the most critical factor for the stability of LAIV; salt concentration and initial virus titer are also important for LAIV stability. With these data, we developed a liquid formulation consisting of 2.5% sucrose, 0.1% monosodium glutamate, 1% arginine, and 0.5% human serum albumin, with pH ranging from 6.2 to 6.9 (optimum pH 6.5-6.7), for optimal production of monovalent or trivalent LAIVs. This liquid formulation has the potential to considerably improve vaccine production capacity to compensate for the immense shortfall in influenza vaccines globally.

journal_name

J Pharm Sci

authors

Sun Y,Shen Z,Zhang C,Yi Y,Zhu K,Xu F,Kong W

doi

10.1016/j.xphs.2019.02.017

subject

Has Abstract

pub_date

2019-07-01 00:00:00

pages

2315-2322

issue

7

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(19)30133-9

journal_volume

108

pub_type

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