Abstract
A review of national and foreign scientific and patent literature, as well as the regulatory documents on the lyophilisation of inactivated vaccines, is presented. According to the State Register of Medicinal Products, all inactivated vaccines produced in dried form in the Russian Federation are obtained by freeze-drying. The excipients (drying media) used in the freeze-drying of vaccines are evaluated in terms of their qualitative and quantitative composition. A review of the features of the main stages of freeze-drying processes, e.g. freezing, sublimation (primary drying) and desorption (secondary drying) is given alongside an analysis of their distinctive features. The information on inactivated vaccines in the lyophilisate form registered in the Russian Federation is systematised. Available information on inactivated vaccines produced in the United States in the form of a lyophilisate is also presented. An analysis of the literature data reveals a significant variety of excipients used in lyophilisation. The influence of the sealing method of consumer packaging on the quality of preparations is considered, i.e. either in the oxygen or inert gas media or under vacuum. It is noted that the entire range of vaccines produced and registered in Russia is sealed under vacuum or in inert gas (i.e. in the absence of oxygen). A number of examples are cited to demonstrate the effect of technological freeze -drying process parameters on the quality of the preparations. It is shown that the preservation of a vaccine's properties during freeze-drying is influenced by a number of parameters, including the freezing rate and the temperature-time parameters of the primary drying and desorption processes. It is established that the correct selection of the qualitative and quantitative characteristics of the drying medium contributes to the preservation of the target properties of lyophilised preparations. The analysis of literature data allows the influence of the parameters described in the review to be considered when developing the technology for the production of immunobiological preparations for the prevention and treatment of infectious diseases.
Highlights
The first mention of the preparation and use of inactivated vaccines, i.e. vaccines not containing live microorganisms, dates back to the end of the 19th century [1]
The first lyophilised inactivated vaccines, the technology for which was developed in the early 1960s, were the Rab-Avert and Rabipur rabies vaccines, prepared on the basis of the inactivated of the Flury LEP rabies virus [3]
The above statement is confirmed by the fact that the inactivated purified concentrated lyophilised cultural tick-borne encephalitis vaccine produced by Chumakov Federal Scientific Center for Research and Development of Immune-and- Biological Products of Russian Academy of Sciences has a shelf life of 3 years, while a similar vaccine in the form of a suspension manufactured by NPO Microgen can only be safely stored for 2 years
Summary
The first mention of the preparation and use of inactivated vaccines, i.e. vaccines not containing live microorganisms, dates back to the end of the 19th century [1]. It is worth noting that the lyophilisation of the preparation was carried out without the use of a drying medium and that the vaccine ampoules were sealed in atmospheric air These technological methods are currently used in the production of cholera vaccines in tablet form at the stage of freeze-drying the immunogenic components [25]. 1 ml of a preparation containing HBV surface antigen adsorbed on aluminium hydroxide gel (40 μg/ml of protein), lactose (10.0 w/v%), glycine (1.0 w/v%), gelatine (0.05 w/v%), thiomersal (0.005 w/v%) and phosphate buffer (pH 6.0) was dispensed into 2 ml vials and frozen at a temperature of minus 50 °С for 6 hours.
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