Academic Journal
Critical chemistry manufacturing and controls considerations for mRNA lipid nanoparticle translation.
| Τίτλος: | Critical chemistry manufacturing and controls considerations for mRNA lipid nanoparticle translation. |
|---|---|
| Συγγραφείς: | Liu, Lanbo, Wang, Yan, Gao, Hua, Ruan, Jinghui, Lu, Wenna, Liu, Tianzhu, Li, Xun, Zhang, Guo-Qiang, Xiao, Yating |
| Πηγή: | Discover Nano; 8/13/2026, Vol. 21 Issue 1, p1-21, 21p |
| Θεματικοί όροι: | Nanoparticles, Messenger RNA, Liposomes, Biotechnology, Chemical process control, Regulatory compliance, Pharmaceutical chemicals manufacturing, Drug delivery systems |
| Περίληψη: | Messenger ribonucleic acid (mRNA) therapeutics have advanced rapidly, but their translation remains constrained by delivery performance, manufacturing robustness, and regulatory expectations. Lipid nanoparticles (LNPs) are the most clinically established non-viral delivery platform, yet their successful development depends on a well-defined chemistry, manufacturing, and controls (CMC) strategy that links lipid chemotype and process parameters to critical quality attributes (CQAs) and, ultimately, clinical performance. This review examines translation-critical decisions in mRNA-LNP development, beginning with a comparison of ionizable and permanently cationic lipid chemotypes in terms of efficacy–tolerability trade-offs, biodegradability, and immune activation. We then contrast LNPs with polymeric and hybrid carriers, with emphasis on characterization burden, scalability, and regulatory precedent. Manufacturing approaches, including microfluidic scale-out and impinging-jet scale-up, are further discussed in relation to their effects on CQAs, critical process parameter (CPP) sensitivity, comparability, and cost. Beyond formulation and processing, we highlight the need for orthogonal analytical characterization, physiological stability assessment in plasma or serum, and stability-indicating profiling of lipid impurities and mRNA–lipid adducts. We also discuss AI/ML-ready metadata standards and early comparability planning for scale-up and post-approval changes. Together, these considerations provide a practical CMC-oriented framework for aligning formulation design, manufacturing control, and clinical translation of mRNA-LNP products. [ABSTRACT FROM AUTHOR] |
| Copyright of Discover Nano is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Βάση Δεδομένων: | Complementary Index |
| FullText | Text: Availability: 0 CustomLinks: – Url: https://dx.doi.org/doi:10.1186/s11671-026-04864-4 Name: EDS - Springer Nature Journals (s7799221) Category: fullText Text: View record at Springer – Url: https://resolver.ebsco.com/c/fiv2js/result?sid=EBSCO:edb&genre=article&issn=27319229&ISBN=&volume=21&issue=1&date=20260813&spage=1&pages=1-21&title=Discover Nano&atitle=Critical%20chemistry%20manufacturing%20and%20controls%20considerations%20for%20mRNA%20lipid%20nanoparticle%20translation.&aulast=Liu%2C%20Lanbo&id=DOI:10.1186/s11671-026-04864-4 Name: Full Text Finder (for New FTF UI) (ns324271) Category: fullText Text: Full Text Finder MouseOverText: Full Text Finder |
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| Items | – Name: Title Label: Title Group: Ti Data: Critical chemistry manufacturing and controls considerations for mRNA lipid nanoparticle translation. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Liu%2C+Lanbo%22">Liu, Lanbo</searchLink><br /><searchLink fieldCode="AR" term="%22Wang%2C+Yan%22">Wang, Yan</searchLink><br /><searchLink fieldCode="AR" term="%22Gao%2C+Hua%22">Gao, Hua</searchLink><br /><searchLink fieldCode="AR" term="%22Ruan%2C+Jinghui%22">Ruan, Jinghui</searchLink><br /><searchLink fieldCode="AR" term="%22Lu%2C+Wenna%22">Lu, Wenna</searchLink><br /><searchLink fieldCode="AR" term="%22Liu%2C+Tianzhu%22">Liu, Tianzhu</searchLink><br /><searchLink fieldCode="AR" term="%22Li%2C+Xun%22">Li, Xun</searchLink><br /><searchLink fieldCode="AR" term="%22Zhang%2C+Guo-Qiang%22">Zhang, Guo-Qiang</searchLink><br /><searchLink fieldCode="AR" term="%22Xiao%2C+Yating%22">Xiao, Yating</searchLink> – Name: TitleSource Label: Source Group: Src Data: Discover Nano; 8/13/2026, Vol. 21 Issue 1, p1-21, 21p – Name: Subject Label: Subject Terms Group: Su Data: <searchLink fieldCode="DE" term="%22Nanoparticles%22">Nanoparticles</searchLink><br /><searchLink fieldCode="DE" term="%22Messenger+RNA%22">Messenger RNA</searchLink><br /><searchLink fieldCode="DE" term="%22Liposomes%22">Liposomes</searchLink><br /><searchLink fieldCode="DE" term="%22Biotechnology%22">Biotechnology</searchLink><br /><searchLink fieldCode="DE" term="%22Chemical+process+control%22">Chemical process control</searchLink><br /><searchLink fieldCode="DE" term="%22Regulatory+compliance%22">Regulatory compliance</searchLink><br /><searchLink fieldCode="DE" term="%22Pharmaceutical+chemicals+manufacturing%22">Pharmaceutical chemicals manufacturing</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+delivery+systems%22">Drug delivery systems</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Messenger ribonucleic acid (mRNA) therapeutics have advanced rapidly, but their translation remains constrained by delivery performance, manufacturing robustness, and regulatory expectations. Lipid nanoparticles (LNPs) are the most clinically established non-viral delivery platform, yet their successful development depends on a well-defined chemistry, manufacturing, and controls (CMC) strategy that links lipid chemotype and process parameters to critical quality attributes (CQAs) and, ultimately, clinical performance. This review examines translation-critical decisions in mRNA-LNP development, beginning with a comparison of ionizable and permanently cationic lipid chemotypes in terms of efficacy–tolerability trade-offs, biodegradability, and immune activation. We then contrast LNPs with polymeric and hybrid carriers, with emphasis on characterization burden, scalability, and regulatory precedent. Manufacturing approaches, including microfluidic scale-out and impinging-jet scale-up, are further discussed in relation to their effects on CQAs, critical process parameter (CPP) sensitivity, comparability, and cost. Beyond formulation and processing, we highlight the need for orthogonal analytical characterization, physiological stability assessment in plasma or serum, and stability-indicating profiling of lipid impurities and mRNA–lipid adducts. We also discuss AI/ML-ready metadata standards and early comparability planning for scale-up and post-approval changes. Together, these considerations provide a practical CMC-oriented framework for aligning formulation design, manufacturing control, and clinical translation of mRNA-LNP products. [ABSTRACT FROM AUTHOR] – Name: Abstract Label: Group: Ab Data: <i>Copyright of Discover Nano is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1186/s11671-026-04864-4 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 21 StartPage: 1 Subjects: – SubjectFull: Nanoparticles Type: general – SubjectFull: Messenger RNA Type: general – SubjectFull: Liposomes Type: general – SubjectFull: Biotechnology Type: general – SubjectFull: Chemical process control Type: general – SubjectFull: Regulatory compliance Type: general – SubjectFull: Pharmaceutical chemicals manufacturing Type: general – SubjectFull: Drug delivery systems Type: general Titles: – TitleFull: Critical chemistry manufacturing and controls considerations for mRNA lipid nanoparticle translation. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Liu, Lanbo – PersonEntity: Name: NameFull: Wang, Yan – PersonEntity: Name: NameFull: Gao, Hua – PersonEntity: Name: NameFull: Ruan, Jinghui – PersonEntity: Name: NameFull: Lu, Wenna – PersonEntity: Name: NameFull: Liu, Tianzhu – PersonEntity: Name: NameFull: Li, Xun – PersonEntity: Name: NameFull: Zhang, Guo-Qiang – PersonEntity: Name: NameFull: Xiao, Yating IsPartOfRelationships: – BibEntity: Dates: – D: 13 M: 08 Text: 8/13/2026 Type: published Y: 2026 Identifiers: – Type: issn-print Value: 27319229 Numbering: – Type: volume Value: 21 – Type: issue Value: 1 Titles: – TitleFull: Discover Nano Type: main |
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