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10.1016/j.xphs.2020.11.015

http://scihub22266oqcxt.onion/10.1016/j.xphs.2020.11.015
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33242452!7682479!33242452
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suck abstract from ncbi


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pmid33242452      J+Pharm+Sci 2021 ; 110 (2): 627-634
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  • The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines #MMPMID33242452
  • Crommelin DJA; Volkin DB; Hoogendoorn KH; Lubiniecki AS; Jiskoot W
  • J Pharm Sci 2021[Feb]; 110 (2): 627-634 PMID33242452show ga
  • Once Covid-19 vaccines become available, 5-10 billion vaccine doses should be globally distributed, stored and administered. In this commentary, we discuss how this enormous challenge could be addressed for viral vector-based Covid-19 vaccines by learning from the wealth of formulation development experience gained over the years on stability issues related to live attenuated virus vaccines and viral vector vaccines for other diseases. This experience has led -over time- to major improvements on storage temperature, shelf-life and in-use stability requirements. First, we will cover work on 'classical' live attenuated virus vaccines as well as replication competent viral vector vaccines. Subsequently, we address replication deficient viral vector vaccines. Freeze drying and storage at 2-8 degrees C with a shelf life of years has become the norm. In the case of pandemics with incredibly high and urgent product demands, however, the desire for rapid and convenient distribution chains combined with short end-user storage times require that liquid formulations with shelf lives of months stored at 2-8 degrees C be considered. In confronting this "perfect storm" of Covid-19 vaccine stability challenges, understanding the many lessons learned from decades of development and manufacturing of live virus-based vaccines is the shortest path for finding promising and rapid solutions.
  • |*Drug Stability[MESH]
  • |*Genetic Vectors[MESH]
  • |COVID-19 Vaccines/*immunology[MESH]
  • |COVID-19/immunology/*prevention & control[MESH]
  • |Drug Compounding[MESH]
  • |Drug Storage[MESH]
  • |Freeze Drying[MESH]
  • |Humans[MESH]
  • |SARS-CoV-2/genetics/*immunology[MESH]


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