Some experiments on freezedrying of inactivated poliomyelitis-vaccines

Abstract

Methods for potency testing of inactivated poliomyelitis-vaccines are still inaccurate. Moreover, the lack of a suitable standard preparation of the vaccine can be felt as a major drawback.Sueh a standard preparation has to fulfill the requirement, that it is stable for a long period. Lyophilization is considered as a very satisfactory method to enhance the stability of biologic products (1).Here some experiments on the lyophilization of inactivated poliovaccines, which have led to a partial success, will be described.Trivalent vaccine lots Nos. 0029, 0031 and 0036, which were routinely produced in our laboratory (trypsinized monkey kidney cells, T. C. medium 199, peniciltine and streptomyeine added as antibiotics) were used in these experiments. The poliovaecines were mixed with an equal amount of solution of 10% pepton and 10~o sorbitol in MeIlvain buffer. This method was introduced in our laboratories for the lyophilization of smallpox vaccine by Brans (2).In this study ampoules containing 1 nil. of the above-mentioned mixtures were shellfrozen at --70 ~ C. Subsequently these ampoules were freeze-dried at --20 ~ C, for 8 hours, followed by drying above PeO~ at room temperature for 14 hours. The final product was stored at +4 ~ C.To test the potencies of our preparations, four groups of three week old chickens were injected intramuscularly, respectively with the dilution 1 : 10, 1:50, 1 : I25 and 1:625 of one dose of the test material. A reference

Development of Thermostable Lyophilized Inactivated Polio Vaccine

“…The appropriate performance of sorbitol combined with mannitol and MSG indicates that the presence of polyols in combination with MSG stabilizes the IPV during lyophilization in a similar way as the disaccharides sucrose and/or trehalose (combined with mannitol) did as shown in the pilot study. In earlier lyophilization studies, sorbitol was used as excipient in combination with peptone ( 22 ), which showed again to be a valuable combination in this experiment, whether or not in the presence of a salt like MgCl 2 or LiCl. Peptone-containing lyophilized IPV formulations, however, showed limited storage stability at elevated temperatures (Fig.…”

“…It has been reported earlier that lyophilization of polio vaccines is challenging. For example, Nagel et al revealed that with the excipients sorbitol and peptone relative potencies of 70% for type 1 and 50% for type 2 could be obtained after lyophilization of IPV, while all activity of type 3 was destroyed ( 22 ). In addition, Pollard et al exhibited that lyophilization of the wild type poliovirus resulted in almost complete inactivation ( 34 ), although it was not determined whether D-antigenicity was also negatively affected.…”

“…In order to obtain an IPV formulation that is suitable for lyophilization we performed a more extensive excipient screening. The selection of excipients for the screening (Table I ) was based on findings from literature ( 20 , 22 , 36 – 40 ) and earlier unpublished data.…”