Assessing Antigen-Adjuvant Complex Stability Against Physical Stresses By wNMR

Taraban, Marc B.; Briggs, Katharine T.; Yu, Yinan; Jones, M. B.; Rosner, Lindsey; Bhambhani, Akhilesh; Williams, Donna M.; Farrell, Christopher; Reibarkh, Mikhail; Su, Yongchao

doi:10.1007/s11095-022-03437-1

Cited by 5 publications

(5 citation statements)

References 49 publications

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“…In addition to analyzing finished vaccine products, as shown in this work, w NMR may also be used in the development and production of aluminum-adjuvanted vaccines, as we demonstrated in a recent study in collaboration with vaccine makers. 20 …”

Section: Resultsmentioning

confidence: 99%

Sedimentation behavior of quality and freeze-damaged aluminum-adjuvanted vaccines by w NMR

Briggs

Taraban

2023

Human Vaccines & Immunotherapeutics

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Vaccine sedimentation and resuspension are properties that vaccine makers use to characterize a suspension product during research and development as well as throughout the shelf life of the vaccine. Three vaccines with three different aluminum adjuvants and different antigens were selected and monitored over the course of sedimentation using water proton nuclear magnetic resonance ( w NMR) relaxometry. This simple method measured fully intact, single-dose vaccine vials and reported sedimentation profiles for each, which readily distinguished freeze-stressed vaccines from unstressed vaccines.

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Section: Resultsmentioning

confidence: 99%

Sedimentation behavior of quality and freeze-damaged aluminum-adjuvanted vaccines by w NMR

Briggs

Taraban

2023

Human Vaccines & Immunotherapeutics

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“…The combined results from the immunoassays (using a panel of mAbs against various epitopes) and the LC-MS peptide mapping analyses (for Cys residue accessibility/redox) provided a “regional-level” perspective on the structural integrity of aluminum-adjuvanted protein antigens upon exposure to stresses such as elevated temperature and the addition of APs. These two methods bridge the gap between commonly used, lower-resolution biophysical techniques that monitor “global” structural alterations in antigens (e.g., DSC, fluorescence spectroscopy, FTIR) and more recent work with highly specialized, higher-resolution analytical approaches that monitor “local” structural changes (e.g., cryo-electron microscopy [ 13 ], nuclear magnetic resonance spectroscopy [ 58 ]). To this end, this work demonstrates the utility of “regional-level” structural analysis methods, as part of vaccine multi-dose formulation development, to provide a better understanding of structural alterations caused by APs occurring within complex vaccine protein antigens (adsorbed to aluminum-salt adjuvants) using more easily accessible analytical techniques.…”

Section: Discussionmentioning

confidence: 99%

A Combined LC-MS and Immunoassay Approach to Characterize Preservative-Induced Destabilization of Human Papillomavirus Virus-like Particles Adsorbed to an Aluminum-Salt Adjuvant

Caringal,

Hickey,

Sharma

et al. 2024

Vaccines

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During the multi-dose formulation development of recombinant vaccine candidates, protein antigens can be destabilized by antimicrobial preservatives (APs). The degradation mechanisms are often poorly understood since available analytical tools are limited due to low protein concentrations and the presence of adjuvants. In this work, we evaluate different analytical approaches to monitor the structural integrity of HPV16 VLPs adsorbed to Alhydrogel™ (AH) in the presence and absence of APs (i.e., destabilizing m-cresol, MC, or non-destabilizing chlorobutanol, CB) under accelerated conditions (pH 7.4, 50 °C). First, in vitro potency losses displayed only modest correlations with the results from two commonly used methods of protein analysis (SDS-PAGE, DSC). Next, results from two alternative analytical approaches provided a better understanding of physicochemical events occurring under these same conditions: (1) competitive ELISA immunoassays with a panel of mAbs against conformational and linear epitopes on HPV16 VLPs and (2) LC-MS peptide mapping to evaluate the accessibility/redox state of the 12 cysteine residues within each L1 protein comprising the HPV16 VLP (i.e., with 360 L1 proteins per VLP, there are 4320 Cys residues per VLP). These methods expand the limited analytical toolset currently available to characterize AH-adsorbed antigens and provide additional insights into the molecular mechanism(s) of AP-induced destabilization of vaccine antigens.

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“…35 Several adjuvants frequently have a definite shelf life and may be compromised by prolonged storage conditions. 37 Nanovaccines that are lipid-based, mainly frozen ones, can be damaged by freeze−thaw cycles during storage or transportation. Lipid-based nanovaccine adjuvants can be sensitive to freeze−thaw stress, affecting their physical characteristics or causing them to lose effectiveness.…”

Section: Impact Of Storage Condition On Adjuvantmentioning

confidence: 99%

“…Specific vaccination components and some adjuvants may interact, resulting in diminished efficacy or unfavorable reactions . Several adjuvants frequently have a definite shelf life and may be compromised by prolonged storage conditions . Nanovaccines that are lipid-based, mainly frozen ones, can be damaged by freeze–thaw cycles during storage or transportation.…”

Section: Challenges In Vaccine Development Delivery and Efficacymentioning

confidence: 99%

Harnessing Nanovaccines for Effective Immunization─A Special Concern on COVID-19: Facts, Fidelity, and Future Prospective

Gholap,

Gupta,

Kamandar

et al. 2023

ACS Biomater. Sci. Eng.

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Nanotechnology has emerged as a transformative pathway in vaccine research and delivery. Nanovaccines, encompassing lipid and nonlipid formulations, exhibit considerable advantages over traditional vaccine techniques, including enhanced antigen stability, heightened immunogenicity, targeted distribution, and the potential for codelivery with adjuvants or immune modulators. This review provides a comprehensive overview of the latest advancements and applications of lipid and non-lipid-based nanovaccines in current vaccination strategies for immunization. The review commences by outlining the fundamental concepts underlying lipid and nonlipid nanovaccine design before delving into the diverse components and production processes employed in their development. Subsequently, a comparative analysis of various nanocarriers is presented, elucidating their distinct physicochemical characteristics and impact on the immune response, along with preclinical and clinical studies. The discussion also highlights how nanotechnology enables the possibility of personalized and combined vaccination techniques, facilitating the creation of tailored nanovaccines to meet the individual patient needs. The ethical aspects concerning the use of nanovaccines, as well as potential safety concerns and public perception, are also addressed. The study underscores the gaps and challenges that must be overcome before adopting nanovaccines in clinical practice. This comprehensive analysis offers vital new insights into lipid and nonlipid nanovaccine status. It emphasizes the significance of continuous research, collaboration among interdisciplinary experts, and regulatory measures to fully unlock the potential of nanotechnology in enhancing immunization and ensuring a healthier, more resilient society.

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Assessing Antigen-Adjuvant Complex Stability Against Physical Stresses By wNMR

Cited by 5 publications

References 49 publications

Sedimentation behavior of quality and freeze-damaged aluminum-adjuvanted vaccines by w NMR

Sedimentation behavior of quality and freeze-damaged aluminum-adjuvanted vaccines by w NMR

A Combined LC-MS and Immunoassay Approach to Characterize Preservative-Induced Destabilization of Human Papillomavirus Virus-like Particles Adsorbed to an Aluminum-Salt Adjuvant

Harnessing Nanovaccines for Effective Immunization─A Special Concern on COVID-19: Facts, Fidelity, and Future Prospective

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