Release and Stability Testing Programs for a Novel Virus-Like Particle Vaccine - Release testing involves both standard potency assays and unique assays (particle size, NA activity) developed to

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Release and Stability Testing Programs for a Novel Virus-Like Particle Vaccine
Release testing involves both standard potency assays and unique assays (particle size, NA activity) developed to ensure the physical, chemical, and biological stability of this type of vaccine.


BioPharm International Supplements



Figure 5. Reverse-phase HPLC peak identification of proteins in the A/Brisbane H1N1 strain of a virus-like particle
An alternative method based on reverse-phase HPLC of VLP samples is being developed to identify the proteins in VLP lots. The protein peaks are identified either by Western blot using specific antisera or by fraction collection and analysis by mass spectrometry. A typical VLP profile with currently identified protein peaks is presented in Figure 5. Currently, this method can identify the influenza HA, NA, and M1 proteins as well as the baculovirus gp64 protein.

Stability Testing

During clinical development, a stability testing program is established to 1) demonstrate vaccine stability during the time it is administered to volunteers and 2) begin to collect data to allow the assignment of vaccine shelf life upon approval for marketing.


Table 6. Stability testing results of 60 g HA/mL dose of trivalent 2008–2009 influenza VLP vaccine
Table 6 presents 12-month stability data generated for the 60 g HA/mL VLP lot of 2008–2009 trivalent seasonal VLP vaccine administered to healthy adults in a clinical trial (Table 2). The analytical testing parameters that were followed were 1) particle size, 2) SRID HA value for each strain in the vaccine, 3) vaccine purity/identity by SDS–PAGE and Western blot and 4) total NA activity. These measurements allow us to track potency and physical characteristics of the vaccine over the course of the study. The results demonstrated no change in the physical properties of the vaccine over 12 months and showed stability of the HA potency for all three components and consistent NA activity over the 12-month study.


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