2013
DOI: 10.4161/hv.25852
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Biophysical characterization and immunization studies of dominant negative inhibitor (DNI), a candidate anthrax toxin subunit vaccine

Abstract: Dominant Negative Inhibitor (DNI) is a translocation-deficient homolog of recombinant protective antigen of Bacillus anthracis that is a candidate for a next generation anthrax vaccine. This study demonstrates that the biophysical characteristics of the DNI protein stored in lyophilized form at 4°C for 8 y were similar to recombinant Protective Antigen (rPA). To provide information on the accelerated stability of DNI, samples in the lyophilized form were subjected to thermal stress (40°C and 70°C for up to 4 w… Show more

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Cited by 8 publications
(12 citation statements)
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“…Lyophilized DNI (batch 803918A; Baxter Pharmaceutical Solutions LLC, Bloomington, IN) was reconstituted in sterile water [15]. RiVax (batch 190-100L-GLP-FF-090105) was stored at −20°C in 50% glycerol and 50% histidine buffer (10mM histidine, 144mM NaCl, pH 6.0) [16].…”
Section: Resultsmentioning
confidence: 99%
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“…Lyophilized DNI (batch 803918A; Baxter Pharmaceutical Solutions LLC, Bloomington, IN) was reconstituted in sterile water [15]. RiVax (batch 190-100L-GLP-FF-090105) was stored at −20°C in 50% glycerol and 50% histidine buffer (10mM histidine, 144mM NaCl, pH 6.0) [16].…”
Section: Resultsmentioning
confidence: 99%
“…Ricin TNA was determined using a Vero cell cytotoxicity assay [17]. LT-neutralizing activity was determined using a J774 murine macrophage cell-based assay [15, 18]. Neutralization activity was defined as the highest dilution of serum that protected ≥50% of the cells from toxin-induced death, a value commonly referred to as the TCIC 50 .…”
Section: Resultsmentioning
confidence: 99%
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“…Preliminary studies in synthesizing and determining the immunogenicity of a PCMV were performed using the T-independent capsular antigen, poly-gamma-D-glutamic acid (PGA), and the carrier/matrix protein DNI, or dominant negative inhibitor, a mutant of the protective antigen (PA) moiety of anthrax toxin (14)(15)(16), derived from B. anthracis. PGA is an atypical capsule in that it is a linear polypeptide generated through gamma peptide bonds of glutamic acid rather than the more common polysaccharide-based capsules (17,18).…”
Section: Resultsmentioning
confidence: 99%
“…The vast majority of formulation efforts on vaccines have adopted empirical approaches based on historical data of related products . The limited formulation strategies discussed in the literature for vaccine development are focused on the stability of the antigens and not so much on the stability of the bulk suspension . This is mainly due to the lack of clear understanding of the relationship between the suspension behavior of vaccines and their immunogenicity .…”
Section: Introductionmentioning
confidence: 99%