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DoE-derived continuous and robust process for manufacturing of pharmaceutical-grade wide-range LNPs for RNA-vaccine/drug delivery.

DoE-derived continuous and robust process for manufacturing of pharmaceutical-grade wide-range LNPs for RNA-vaccine/drug delivery.

Authors :
Nag, Kakon
Sarker, Md. Enamul Haq
Kumar, Samir
Khan, Habiba
Chakraborty, Sourav
Islam, Md. Jikrul
Baray, Juwel Chandra
Khan, Maksudur Rahman
Mahmud, Asif
Barman, Uttam
Bhuiya, Eleus Hussain
Mohiuddin, Mohammad
Sultana, Naznin
Source :
Scientific Reports; 6/7/2022, Vol. 12 Issue 1, p1-11, 11p
Publication Year :
2022

Abstract

Lipid nanoparticle (LNP) technology has become extremely demanding for delivering RNA-products and other drugs. However, there is no platform to manufacture pharmaceutical-grade LNPs with desired particle size from a wide range in continuous mode. We have developed a unique platform to obtain any specific size-range of LNPs from 60 to 180 nm satisfying pharmaceutical regulatory requirements for polydispersity index, sterility, dose uniformity and bio-functionality. We applied design of experiment (DoE) methodology and identified the critical process parameters to establish the process for global application. Cross-point validation within the response map of DoE confirmed that the platform is robust to produce specific size (± 10 nm) of LNPs within the design-range. The technology is successfully transformed to production scale and validated. Products from R&D, pilot and production batches for a candidate SARS-CoV-2 mRNA-vaccine generated equivalent biological responses. The data collectively established the robustness and bio-uniformity of doses for global RNA-vaccine/drug formulation. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
20452322
Volume :
12
Issue :
1
Database :
Complementary Index
Journal :
Scientific Reports
Publication Type :
Academic Journal
Accession number :
157305808
Full Text :
https://doi.org/10.1038/s41598-022-12100-z