Concentration Determination of a Recombinant Vaccine Antigen Adsorbed onto an Alum Adjuvant by Chemiluminescent Nitrogen Detection

Amari, John V.; Levesque, Philip; Lian, Zhirui; Lowden, Trish; deAlwis, Uditha

doi:10.1007/s11095-004-9006-2

Cited by 8 publications

(5 citation statements)

References 29 publications

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“… 54 Limitations of the assay include its sensitivity, because it can only be used for protein concentrations greater than 25 µg/ml, and that it is unsuitable for some formulations, due to interference from excipients containing amine groups (such as Tris buffer). An alternative method is to measure total nitrogen content by chemiluminescence, 55 although this technique is also subject to interference from excipients containing amine groups. In addition, the specific adsorption of antigens can be determined with panels of monoclonal antibodies by either plate-based fluorescence or flow cytometry.…”

Section: Formulation Of Vaccines With Aluminum Adjuvantsmentioning

confidence: 99%

Optimizing the utilization of aluminum adjuvants in vaccines: you might just get what you want

2018

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Aluminum-containing adjuvants have been used for over 90 years to enhance the immune response to vaccines. Recent work has significantly advanced our understanding of the physical, chemical, and biological properties of these adjuvants, offering key insights on underlying mechanisms. Given the long-term success of aluminum adjuvants, we believe that they should continue to represent the “gold standard” against which all new adjuvants should be compared. New vaccine candidates that require adjuvants to induce a protective immune responses should first be evaluated with aluminum adjuvants before other more experimental approaches are considered, since use of established adjuvants would facilitate both clinical development and the regulatory pathway. However, the continued use of aluminum adjuvants requires an appreciation of their complexities, in combination with access to the necessary expertise to optimize vaccine formulations. In this article, we will review the properties of aluminum adjuvants and highlight those elements that are critical to optimize vaccine performance. We will discuss how other components (excipients, TLR ligands, etc.) can affect the interaction between adjuvants and antigens, and impact the potency of vaccines. This review provides a resource and guide, which will ultimately contribute to the successful development of newer, more effective and safer vaccines.

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Section: Formulation Of Vaccines With Aluminum Adjuvantsmentioning

confidence: 99%

Optimizing the utilization of aluminum adjuvants in vaccines: you might just get what you want

2018

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“…However, to the best of our knowledge there are currently no in vitro antigen-specific methods to determine the quality of adjuvanted vaccines formulated as water-in-oil emulsions that do not require extraction of the antigen. Methods that nonspecifically determine protein content are compatible with aluminum salt adjuvants, including fluorescence spectroscopy, based on intrinsic fluorescence of tyrosine and tryptophan amino acids or fluorescent protein-reactive chemicals, and chemiluminescent nitrogen detection [114][115][116]. These methods are not antigen-specific and therefore not suitable for vaccines that contain antigens in complex media with other proteins, e.g.…”

Section: Adjuvanted Vaccinesmentioning

confidence: 99%

Overcoming scientific barriers in the transition fromin vivoto non-animal batch testing of human and veterinary vaccines

Biggelaar

Hoefnagel

Vandebriel

et al. 2021

Expert Review of Vaccines

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Introduction: Before release, vaccine batches are assessed for quality to evaluate whether they meet the product specifications. Vaccine batch tests, in particular of inactivated and toxoid vaccines, still largely rely on in vivo methods. Improved vaccine production processes, ethical concerns, and suboptimal performance of some in vivo tests have led to the development of in vitro alternatives.Areas covered: This review describes the scientific constraints that need to be overcome for replacement of in vivo batch tests, as well as potential solutions. Topics include the critical quality attributes of vaccines that require testing, the use of cell-based assays to mimic aspects of in vivo vaccine-induced immune responses, how difficulties with testing adjuvanted vaccines in vitro can be overcome, the use of altered batches to validate new in vitro test methods, and how cooperation between different stakeholders is key to moving the transition forward. Expert opinion: For safety testing, many in vitro alternatives are already available or at an advanced level of development. For potency testing, in vitro alternatives largely comprise immunochemical methods that assess several, but not all critical vaccine properties. One-to-one replacement by in vitro alternatives is not always possible and a combination of methods may be required.

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“…The degree of protein adsorption in each of the vaccine formulations was determined by removing the clear supernatant of vaccine samples centrifuged at 13,000g for 15 minutes and analyzing them by chemiluminescent nitrogen analysis 25 performed with a TN-110 Elemental Analyzer composed of the following components: Automatic Boat Controller (ABC), TN-110 main module and Nitrogen Detector (COSA Instrument Corporation, Norwood, NJ, USA). The percent adsorbed protein antigen was determined by mass balance.…”

Section: Adjuvantsmentioning

confidence: 99%

Association Between Immunogenicity and Adsorption of a RecombinantStreptococcus pneumoniaeVaccine Antigen by an Aluminum Adjuvant

Levesque¹,

Foster²,

Alwis³

2006

Human Vaccines

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The impact on immunogenicity of the degree of adsorption of three Streptococcus pneumoniae (Sp) vaccine antigens to aluminum adjuvants was studied. The three antigens evaluated (Sp1, Sp2 and Sp3) were highly adsorbed by aluminum hydroxide adjuvant, but not adsorbed by aluminum phosphate adjuvant. All of the Sp antigens adjuvanted with aluminum hydroxide elicited higher antibody responses in mice than formulations prepared with aluminum phosphate or non-adjuvanted antigen. Varying the percent aluminum-bound Sp antigen in the formulated vaccine affected the observed antibody responses. These observations suggest that the antibody response observed for Sp antigens in this study is stimulated by a depot effect of the antigen bound to an aluminum adjuvant.

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Concentration Determination of a Recombinant Vaccine Antigen Adsorbed onto an Alum Adjuvant by Chemiluminescent Nitrogen Detection

Abstract: This methodology provides a direct measurement of the concentration of a vaccine antigen adsorbed onto an aluminum adjuvant.

Cited by 8 publications

References 29 publications

Optimizing the utilization of aluminum adjuvants in vaccines: you might just get what you want

Optimizing the utilization of aluminum adjuvants in vaccines: you might just get what you want

Overcoming scientific barriers in the transition fromin vivoto non-animal batch testing of human and veterinary vaccines

Association Between Immunogenicity and Adsorption of a RecombinantStreptococcus pneumoniaeVaccine Antigen by an Aluminum Adjuvant

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