1. DoE-derived continuous and robust process for manufacturing of pharmaceutical-grade wide-range LNPs for RNA-vaccine/drug delivery.
- Author
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Nag K, Sarker MEH, Kumar S, Khan H, Chakraborty S, Islam MJ, Baray JC, Khan MR, Mahmud A, Barman U, Bhuiya EH, Mohiuddin M, and Sultana N
- Subjects
- Humans, Liposomes, RNA, Small Interfering, SARS-CoV-2 genetics, COVID-19 prevention & control, Nanoparticles
- 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., (© 2022. The Author(s).)
- Published
- 2022
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