Abstract

Research Article

Next Generation Tools in mRNA Purification: The Role of Continuous Raman Spectroscopy Testing with Pretreatment of the Sample

Luisetto M*, Nili B Ahmadabadi, Khaled Edbey and Oleg Yurevich Latyshev

Published: 29 March, 2024 | Volume 8 - Issue 1 | Pages: 021-023

In the biopharmaceutical production field, the purification process is a crucial step in order to obtain Drugs with an impurity profile according to the regulatory agency requirement.
The aim of this work is to verify some relevant and recent literature and after analysis to submit to the researcher new Solutions in order to improve global safety and the toxicological profile: Submit a project related to the continuous testing of the purified materials using Raman spectroscopy – with pre-treatment of the sample: using solvents.
Nanolipis Payload of Biopharmaceutical is not efficiently detected by direct Raman spectroscopy allowed by the regulatory agency for PAT process analytical technology.

Read Full Article HTML DOI: 10.29328/journal.apps.1001052 Cite this Article Read Full Article PDF

Keywords:

mRNA; Purifications; Chromatography; Separations; Columns; Resins; Monoliths; Activated carbon; Raman spectroscopy; Pre-treatment of sample; Continuous testing systems

References

  1. Campra P. Almeria University https://www.researchgate.net/publication/355979001_DETECTION_OF_GRAPHENE_IN_COVID19_VACCINES-
  2. Luisetto M, Ahmadabadi NB, Ettarhouni ZO, Edbey K, Latyshev OY. Monoliths in the mRNA Vaccine Purification Process the Silica Resin and Other Composite Materials: The Carbon Content. Int Case Rep Jour. 2022; 2(7):1-23.
  3. Luisetto M, Edbey K, Tarro G, Ahmadabadi NB, Khan FA. Activated Charcoal and Derivate Materials in Drugs and Biopharmaceutical Purification: Impurity Aspects. J Mater Sci Nanotechnol. 2023; 11(1):105.
  4. Cipelli RB, Giovannini F, Dark GP. Field Microscopic Analysis on the Blood of 1,006 Symptomatic Persons After Anti-COVID mRNA Injections from Pfizer/BioNtech or Moderna International Journal of Vaccine Theory, Practice, and Research. 2022-08-12. Journal article DOI: 10.56098/ijvtpr.v2i2.47 CONTRIBUTORS:
  5. Luisetto M. Raman (Rs) Spectroscopy for Biopharmaceutical Quality Control and PAT. Raw Material - Final Products: the Nanolipids Effect on Signal Intensity. Regulatory and Toxicological Aspects. Med & Analy Chem Int J. 2022; 6(1): 000175.
  6. Vanden-Hehir S, Tipping WJ, Lee M, Brunton VG, Williams A, Hulme AN. Raman Imaging of Nanocarriers for Drug Delivery. Nanomaterials (Basel). 2019 Mar 3;9(3):341. doi: 10.3390/nano9030341. PMID: 30832394; PMCID: PMC6474004.
  7. Activated charcoal BP monography.
  8. Luisetto WM. Amorphous substance (activated charcoal) and other impurities in API manufacturing process. Pharmaceutical, toxicological and regulatory implication. 2023.
  9. Robert OY. Scanning & Transmission Electron Microscopy Reveals Graphene Oxide in CoV-19 Vaccines 2021. February 5th, Updated September 11th, 2021. www.drrobertyoung.com

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