PHARMACEUTICAL - A simple solution for cold chain problem

Thermal Stabilization of Viral Vaccines in Low-Cost Sugar Films

Vincent Leung, Jonathan Mapletoft, Ali Zhang, Amanda Lee, Fatemeh Vahedi, Marianne Chew, Alexandra Szewczyk, Sana Jahanshahi-Anbuhi, Jann Ang, Braeden Cowbrough, Matthew S. Miller, Ali Ashkar & Carlos D. M. Filipe

Most currently available vaccines, particularly live vaccines, require the cold chain, as vaccine efficacy can be significantly hampered if they are not stored in a temperature range of 2–8 °C at all times. This necessity places a tremendous financial and logistical burden on vaccination programs, particularly in the developing world. The development of thermally stable vaccines can greatly alleviate this problem and, in turn, increase vaccine accessibility worldwide. In ...

Sci. Rep. 2019;9:7631.

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Spray dried VSV‑vectored vaccine is thermally stable and immunologically active in vivo

Steven P. Toniolo, Sam Afkhami, Michael R. D’Agostino, Brian D. Lichty, Emily D. Cranston, Zhou Xing & Michael R. Thompson

Effective vaccine delivery and coverage to rural and resource-poor countries is hindered by the dependence on cold chain storage. As such, developments of cold chain-free technologies are highly sought. Although spray dried adenoviral vectors have shown long term stability at ambient temperatures and relatively low humidity, it remains to be determined whether similar excipient formulations are applicable to other viral vectors. To address this, we have spray dried ...

Sci. Rep. 2020;10:13349.

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Novel platform technology for modular mucosal vaccine that protects against streptococcus

Mehfuz Zaman, Victoria Ozberk, Emma L. Langshaw, Virginia McPhun, Jessica L. Powell, Zachary N. Phillips, Mei Fong Ho, Ainslie Calcutt, Michael R. Batzloff, Istvan Toth, Geoffrey R. Hill, Manisha Pandey & Michael F. Good

The upper respiratory tract (URT) is the major entry site for human pathogens and strategies to activate this network could lead to new vaccines capable of preventing infection with many pathogens. Group A streptococcus (GAS) infections, causing rheumatic fever, rheumatic heart disease, and invasive disease, are responsible for substantial morbidity and mortality. We describe an innovative vaccine strategy to induce mucosal antibodies of significant magnitude against peptide antigens ...

Sci. Rep. 2016;6:39274.

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Trehalose significantly enhances the recovery of serum and serum exosomal miRNA from a paper-based matrix

Shu Hui Neo, Ka Yan Chung, Jia Min Quek & Heng-Phon Too

The preservation of nucleic acids from clinical samples is critical to facilitate accurate molecular diagnosis. The use of a paper matrix, Flinders Technology Associates (FTA) Elute cards, to archive DNA and viral RNA is well-documented. However, the feasibility of FTA Elute cards for archiving serum and serum exosomal microRNAs (miRNAs) remains unclear. Here, we performed a comprehensive evaluation of FTA Elute cards for miRNA storage and recovery in ...

Sci. Rep. 2017;7:16686.

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Preservation of the Immunogenicity of Dry-powder Influenza H5N1 Whole Inactivated Virus Vaccine at Elevated Storage Temperatures

Felix Geeraedts, Vinay Saluja, Wouter ter Veer, Jean-Pierre Amorij, Henderik W. Frijlink, Jan Wilschut, Wouter L. J. Hinrichs & Anke Huckriede

Stockpiling of pre-pandemic influenza vaccines guarantees immediate vaccine availability to counteract an emerging pandemic. Generally, influenza vaccines need to be stored and handled refrigerated to prevent thermal degradation of the antigenic component. Requirement of a cold-chain, however, complicates stockpiling and the logistics of vaccine distribution. We, therefore, investigated the effect of elevated storage temperatures on the immunogenicity of a pre-pandemic influenza A H5N1 whole inactivated virus vaccine. Either ...

AAPS J. 2010;12:215-222.

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Long-term storage of DNA-free RNA for use in vaccine studies

Kathryn L. Jones, Debbie Drane & Eric J. Gowans

RNA replicons represent potential vaccine delivery vehicles, but are considered too unstable for such use. This study examined the recovery, integrity and function of in vitro transcribed replicon RNA encoding hepatitis C virus (HCV) proteins. To remove residual template DNA, the RNA was digested with TURBO DNase followed by RNeasy DNase set and purified through an RNeasy column. The RNA was freeze-dried in distilled water or trehalose, stored ...

BioTechniques. 2007;43:675-681.

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Trehalose prevents aggregation of exosomes and cryodamage

Steffi Bosch, Laurence de Beaurepaire, Marie Allard, Mathilde Mosser, Claire Heichette, Denis Chrétien, Dominique Jegou & Jean-Marie Bach

Exosomes are important mediators in intercellular communication. Released by many cell types, they transport proteins, lipids, and nucleic acids to distant recipient cells and contribute to important physiopathological processes. Standard current exosome isolation methods based on differential centrifugation protocols tend to induce aggregation of particles in highly concentrated suspensions and freezing of exosomes can induce damage and inconsistent biological activity. Trehalose is a natural, non-toxic sugar widely used ...

Sci. Rep. 2016;6:36162.

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Formulation Stabilization and Disaggregation of Bevacizumab, Ranibizumab and Aflibercept in Dilute Solutions

Steven A. Giannos, Edward R. Kraft, Zhen-Yang Zhao, Kevin H. Merkley & Jiyang Cai

Studies were conducted to investigate dilute solutions of the monoclonal antibody (mAb) bevacizumab, mAb fragment ranibizumab and fusion protein aflibercept, develop common procedures for formulation of low concentration mAbs and identify a stabilizing formulation for anti-VEGF mAbs for use in in vitro permeation studies. Excipient substitutions were screened. The most stabilizing formulation was chosen. Standard dilutions of bevacizumab, ranibizumab and aflibercept were prepared in PBS, manufacturer’s formulation, and ...

Pharm. Res. 2018;35:78.

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Preferential interactions of trehalose, L-arginine.HCl and sodium chloride with therapeutically relevant IgG1 monoclonal antibodies

Chaitanya Sudrik,Theresa Cloutier,Phuong Pham,Hardeep S. Samra &Bernhardt L. Trout

Preferential interactions of weakly interacting formulation excipients govern their effect on the equilibrium and kinetics of several reactions of protein molecules in solution. Using vapor pressure osmometry, we characterized the preferential interactions of commonly used excipients trehalose, L-arginine.HCl and NaCl with three therapeutically-relevant, IgG1 monoclonal antibodies that have similar size and shape, but differ in their surface hydrophobicity and net charge. We further characterized the effect of these ...

MAbs. 2017;9:1155-1168.

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Effect of trehalose on protein structure

Nishant Kumar Jain & Ipsita Roy

Trehalose is a ubiquitous molecule that occurs in lower and higher life forms but not in mammals. Till about 40 years ago, trehalose was visualized as a storage molecule, aiding the release of glucose for carrying out cellular functions. This perception has now changed dramatically. The role of trehalose has expanded, and this molecule has now been implicated in a variety of situations. Trehalose is synthesized as a ...

Protein Sci. 2019;18:24-36.

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