scholarly journals Addressing the Cold Reality of mRNA Vaccine Stability

Author(s):  
Daan J.A. Crommelin ◽  
Thomas J. Anchordoquy ◽  
David B. Volkin ◽  
Wim Jiskoot ◽  
Enrico Mastrobattista
Keyword(s):  
Pharmaceutics ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 2091
Author(s):  
Ana Sara Cordeiro ◽  
Yogita Patil-Sen ◽  
Maitreyi Shivkumar ◽  
Ronak Patel ◽  
Abdulwahhab Khedr ◽  
...  

Viral infections causing pandemics and chronic diseases are the main culprits implicated in devastating global clinical and socioeconomic impacts, as clearly manifested during the current COVID-19 pandemic. Immunoprophylaxis via mass immunisation with vaccines has been shown to be an efficient strategy to control such viral infections, with the successful and recently accelerated development of different types of vaccines, thanks to the advanced biotechnological techniques involved in the upstream and downstream processing of these products. However, there is still much work to be done for the improvement of efficacy and safety when it comes to the choice of delivery systems, formulations, dosage form and route of administration, which are not only crucial for immunisation effectiveness, but also for vaccine stability, dose frequency, patient convenience and logistics for mass immunisation. In this review, we discuss the main vaccine delivery systems and associated challenges, as well as the recent success in developing nanomaterials-based and advanced delivery systems to tackle these challenges. Manufacturing and regulatory requirements for the development of these systems for successful clinical and marketing authorisation were also considered. Here, we comprehensively review nanovaccines from development to clinical application, which will be relevant to vaccine developers, regulators, and clinicians.


2014 ◽  
Vol 10 (6) ◽  
pp. 1669-1681 ◽  
Author(s):  
Gail Whiting ◽  
Jun X Wheeler ◽  
Sjoerd Rijpkema

2015 ◽  
Vol 22 (7) ◽  
pp. 726-741 ◽  
Author(s):  
Bryan E. Hart ◽  
Rose Asrican ◽  
So-Yon Lim ◽  
Jaimie D. Sixsmith ◽  
Regy Lukose ◽  
...  

ABSTRACTThe well-established safety profile of the tuberculosis vaccine strain,Mycobacterium bovisbacille Calmette-Guérin (BCG), makes it an attractive vehicle for heterologous expression of antigens from clinically relevant pathogens. However, successful generation of recombinant BCG strains possessing consistent insert expression has encountered challenges in stability. Here, we describe a method for the development of large recombinant BCG accession lots which stably express the lentiviral antigens, human immunodeficiency virus (HIV) gp120 and simian immunodeficiency virus (SIV) Gag, using selectable leucine auxotrophic complementation. Successful establishment of vaccine stability stems from stringent quality control criteria which not only screen for highly stable complemented BCG ΔleuCDtransformants but also thoroughly characterize postproduction quality. These parameters include consistent production of correctly sized antigen, retention of sequence-pure plasmid DNA, freeze-thaw recovery, enumeration of CFU, and assessment of cellular aggregates. Importantly, these quality assurance procedures were indicative of overall vaccine stability, were predictive for successful antigen expression in subsequent passaging bothin vitroandin vivo, and correlated with induction of immune responses in murine models. This study has yielded a quality-controlled BCG ΔleuCDvaccine expressing HIV gp120 that retained stable full-length expression after 1024-fold amplificationin vitroand following 60 days of growth in mice. A second vaccine lot expressed full-length SIV Gag for >1068-fold amplificationin vitroand induced potent antigen-specific T cell populations in vaccinated mice. Production of large, well-defined recombinant BCG ΔleuCDlots can allow confidence that vaccine materials for immunogenicity and protection studies are not negatively affected by instability or differences between freshly grown production batches.


Vaccine ◽  
2006 ◽  
Vol 24 (7) ◽  
pp. 884-886 ◽  
Author(s):  
Kemba N. Lee ◽  
Christina L. Hutson ◽  
Richard Kline ◽  
Aaron T. Curns ◽  
Cindy Dougherty ◽  
...  

2013 ◽  
Vol 7 ◽  
pp. 34-39 ◽  
Author(s):  
J. Ben Arous ◽  
F. Bertrand ◽  
J. Gaucheron ◽  
O.A. Verkhovsky ◽  
A.P. Kotelnikov ◽  
...  
Keyword(s):  

2016 ◽  
Vol 120 (2) ◽  
pp. 321-328 ◽  
Author(s):  
V. Moresco ◽  
N.A. Damazo ◽  
C.R.M. Barardi

2014 ◽  
Vol 103 (10) ◽  
pp. 3055-3064 ◽  
Author(s):  
Didier Clénet ◽  
Frédéric Imbert ◽  
Patricia Probeck ◽  
Nausheen Rahman ◽  
Salvador F. Ausar

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