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Current Status and Future Perspectives on MRNA Drug Manufacturing.
Webb, Cameron; Ip, Shell; Bathula, Nuthan V; Popova, Petya; Soriano, Shekinah K V; Ly, Han Han; Eryilmaz, Burcu; Nguyen Huu, Viet Anh; Broadhead, Richard; Rabel, Martin; Villamagna, Ian; Abraham, Suraj; Raeesi, Vahid; Thomas, Anitha; Clarke, Samuel; Ramsay, Euan C; Perrie, Yvonne; Blakney, Anna K.
  • Webb C; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom.
  • Ip S; Precision NanoSystems Inc, 655 West Kent Avenue North Unit 50, Vancouver, British Columbia V6P 6T7, Canada.
  • Bathula NV; Michael Smith Laboratories & School of Biomedical Engineering, University of British Columbia, 2185 East Mall, Vancouver, British Columbia V6T 1Z4, Canada.
  • Popova P; Michael Smith Laboratories & School of Biomedical Engineering, University of British Columbia, 2185 East Mall, Vancouver, British Columbia V6T 1Z4, Canada.
  • Soriano SKV; Michael Smith Laboratories & School of Biomedical Engineering, University of British Columbia, 2185 East Mall, Vancouver, British Columbia V6T 1Z4, Canada.
  • Ly HH; Michael Smith Laboratories & School of Biomedical Engineering, University of British Columbia, 2185 East Mall, Vancouver, British Columbia V6T 1Z4, Canada.
  • Eryilmaz B; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom.
  • Nguyen Huu VA; Precision NanoSystems Inc, 655 West Kent Avenue North Unit 50, Vancouver, British Columbia V6P 6T7, Canada.
  • Broadhead R; Precision NanoSystems Inc, 655 West Kent Avenue North Unit 50, Vancouver, British Columbia V6P 6T7, Canada.
  • Rabel M; Precision NanoSystems Inc, 655 West Kent Avenue North Unit 50, Vancouver, British Columbia V6P 6T7, Canada.
  • Villamagna I; Precision NanoSystems Inc, 655 West Kent Avenue North Unit 50, Vancouver, British Columbia V6P 6T7, Canada.
  • Abraham S; Precision NanoSystems Inc, 655 West Kent Avenue North Unit 50, Vancouver, British Columbia V6P 6T7, Canada.
  • Raeesi V; Precision NanoSystems Inc, 655 West Kent Avenue North Unit 50, Vancouver, British Columbia V6P 6T7, Canada.
  • Thomas A; Precision NanoSystems Inc, 655 West Kent Avenue North Unit 50, Vancouver, British Columbia V6P 6T7, Canada.
  • Clarke S; Precision NanoSystems Inc, 655 West Kent Avenue North Unit 50, Vancouver, British Columbia V6P 6T7, Canada.
  • Ramsay EC; Precision NanoSystems Inc, 655 West Kent Avenue North Unit 50, Vancouver, British Columbia V6P 6T7, Canada.
  • Perrie Y; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom.
  • Blakney AK; Michael Smith Laboratories & School of Biomedical Engineering, University of British Columbia, 2185 East Mall, Vancouver, British Columbia V6T 1Z4, Canada.
Mol Pharm ; 19(4): 1047-1058, 2022 04 04.
Article in English | MEDLINE | ID: covidwho-1721386
ABSTRACT
The coronavirus disease of 2019 (COVID-19) pandemic launched an unprecedented global effort to rapidly develop vaccines to stem the spread of the novel severe acute respiratory syndrome coronavirus (SARS-CoV-2). Messenger ribonucleic acid (mRNA) vaccines were developed quickly by companies that were actively developing mRNA therapeutics and vaccines for other indications, leading to two mRNA vaccines being not only the first SARS-CoV-2 vaccines to be approved for emergency use but also the first mRNA drugs to gain emergency use authorization and to eventually gain full approval. This was possible partly because mRNA sequences can be altered to encode nearly any protein without significantly altering its chemical properties, allowing the drug substance to be a modular component of the drug product. Lipid nanoparticle (LNP) technology required to protect the ribonucleic acid (RNA) and mediate delivery into the cytoplasm of cells is likewise modular, as are technologies and infrastructure required to encapsulate the RNA into the LNP. This enabled the rapid adaptation of the technology to a new target. Upon the coattails of the clinical success of mRNA vaccines, this modularity will pave the way for future RNA medicines for cancer, gene therapy, and RNA engineered cell therapies. In this review, trends in the publication records and clinical trial registrations are tallied to show the sharp intensification in preclinical and clinical research for RNA medicines. Demand for the manufacturing of both the RNA drug substance (DS) and the LNP drug product (DP) has already been strained, causing shortages of the vaccine, and the rise in development and translation of other mRNA drugs in the coming years will exacerbate this strain. To estimate demand for DP manufacturing, the dosing requirements for the preclinical and clinical studies of the two approved mRNA vaccines were examined. To understand the current state of mRNA-LNP production, current methods and technologies are reviewed, as are current and announced global capacities for commercial manufacturing. Finally, a vision is rationalized for how emerging technologies such as self-amplifying mRNA, microfluidic production, and trends toward integrated and distributed manufacturing will shape the future of RNA manufacturing and unlock the potential for an RNA medicine revolution.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Mol Pharm Journal subject: Molecular Biology / Pharmacy / Pharmacology Year: 2022 Document Type: Article Affiliation country: Acs.molpharmaceut.2c00010

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Mol Pharm Journal subject: Molecular Biology / Pharmacy / Pharmacology Year: 2022 Document Type: Article Affiliation country: Acs.molpharmaceut.2c00010