Downstream Critical Process Parameters for COVID-19 mRNA LNP Vaccine Production

  • Pradip Iramdhan Aliyansah Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia
  • Adelia Talita Oriana Athoulloh Kalyubi Institut Bio Scientia International Indonesia, Jakarta Indonesia
  • Azura Luna Widiyanto Institut Bio Scientia International Indonesia, Jakarta Indonesia
  • Ervin E Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia
  • Michelle Loavenia Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia
  • Stevanie Putri Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia
  • Tissa Yuan Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia
  • Pietradewi Hartrianti Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia
DOI: https://doi.org/10.54250/ijls.v6i01.205
Keywords: mRNA vaccines, vaccines manufacturing, downstream processing, critical process parameters, lipid nanoparticles (LNPs)

Abstract

The COVID-19 pandemic, triggered by the SARS-CoV-2 virus, has led to global efforts to mitigate its effects, with mRNA vaccines playing a crucial role. These vaccines use the virus's genetic sequence to prompt an immune response without introducing the live pathogen, showcasing substantial efficacy in protective immunity. The production of mRNA vaccines involves complex stages, including critical downstream processes of purification and formulation, vital for ensuring the vaccine's purity, potency, and safety. The structural components of mRNA vaccines, such as the Open Reading Frame (ORF), untranslated regions (UTRs), cap structure, and poly(A) tail, along with the delivery system using lipid nanoparticles (LNPs), are essential for their functionality and efficacy. Optimization of these elements is crucial for enhancing vaccine performance. Conventional, self-amplifying, and trans-amplifying mRNA vaccines represent the different strategies employed to target COVID-19 effectively. Each type utilizes structural and delivery innovations to stimulate a robust immune response. The review underscores the significance of precise control in the manufacturing process, highlighting its role in global health security and the advancement of vaccine technology. By understanding and optimizing critical process parameters (CPPs) in the downstream manufacturing process, the pharmaceutical industry can achieve the highest standards in vaccine production, significantly contributing to the fight against the pandemic and future vaccine development, ensuring a swift, effective response to global health crises. This review paper focuses on the downstream stages of mRNA vaccine production, comparing studies on CPP to emphasize the importance of stringent control measures for vaccine quality, safety, and efficiency.

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Author Biographies

Pradip Iramdhan Aliyansah, Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia

Department of Pharmacy, Institut Bio Scientia International Indonesia

Adelia Talita Oriana Athoulloh Kalyubi, Institut Bio Scientia International Indonesia, Jakarta Indonesia

Department of Pharmacy, Institut Bio Scientia International Indonesia

Azura Luna Widiyanto, Institut Bio Scientia International Indonesia, Jakarta Indonesia

Department of Pharmacy, Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia

Ervin E, Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia

Department of Pharmacy, Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia

Michelle Loavenia, Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia

Department of Pharmacy, Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia

Stevanie Putri, Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia

Department of Pharmacy, Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia

Tissa Yuan, Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia

Department of Pharmacy, Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia

Pietradewi Hartrianti, Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia

Department of Pharmacy, Institut Bio Scientia Internasional Indonesia, Jakarta, Indonesia

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Published
2024-03-31
How to Cite
Aliyansah, P. I., Kalyubi, A., Widiyanto, A., E, E., Loavenia, M., Putri, S., Yuan, T., & Hartrianti, P. (2024). Downstream Critical Process Parameters for COVID-19 mRNA LNP Vaccine Production. Indonesian Journal of Life Sciences, 6(01), 46-67. https://doi.org/https://doi.org/10.54250/ijls.v6i01.205
Issue
2024: IJLS Vol 06 No.01
Section
Bio-product and Services for Sustainable Society
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