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

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 sp...

Full description

Saved in:
Bibliographic Details
Published in:Scientific reports Vol. 12; no. 1; p. 9394
Main 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
Format: Journal Article
Language:English
Published: London Nature Publishing Group UK 07-06-2022
Nature Publishing Group
Nature Portfolio
Subjects:
631/61
639/925
COVID-19 - prevention & control
Design of experiments
Drug delivery
Drug dosages
Ethanol
Humanities and Social Sciences
Humans
Hypotheses
Lipids
Liposomes
mRNA
multidisciplinary
Nanoparticles
Particle size
Pharmaceuticals
RNA, Small Interfering
SARS-CoV-2 - genetics
Science
Science (multidisciplinary)
Severe acute respiratory syndrome coronavirus 2
Solvents
Sterility
Vaccines
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:2045-2322
2045-2322
DOI:10.1038/s41598-022-12100-z