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Chemistry and Art of Developing Lipid Nanoparticles for Biologics Delivery: Focus on Development and Scale-Up.

作者信息

John Rijo, Monpara Jasmin, Swaminathan Shankar, Kalhapure Rahul

机构信息

Department of Pharmaceutical Sciences, Philadelphia College of Pharmacy, Saint Joseph's University, Philadelphia, PA 19104, USA.

Drug Product Development, Astellas Institute of Regenerative Medicine, Westborough, MA 01581, USA.

出版信息

Pharmaceutics. 2024 Jan 19;16(1):131. doi: 10.3390/pharmaceutics16010131.


DOI:10.3390/pharmaceutics16010131
PMID:38276502
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10819224/
Abstract

Lipid nanoparticles (LNPs) have gained prominence as primary carriers for delivering a diverse array of therapeutic agents. Biological products have achieved a solid presence in clinical settings, and the anticipation of creating novel variants is increasing. These products predominantly encompass therapeutic proteins, nucleic acids and messenger RNA. The advancement of efficient LNP-based delivery systems for biologics that can overcome their limitations remains a highly favorable formulation strategy. Moreover, given their small size, biocompatibility, and biodegradation, LNPs can proficiently transport therapeutic moiety into the cells without significant toxicity and adverse reactions. This is especially crucial for the existing and upcoming biopharmaceuticals since large molecules as a group present several challenges that can be overcome by LNPs. This review describes the LNP technology for the delivery of biologics and summarizes the developments in the chemistry, manufacturing, and characterization of lipids used in the development of LNPs for biologics. Finally, we present a perspective on the potential opportunities and the current challenges pertaining to LNP technology.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9315/10819224/d4d68bf6afa4/pharmaceutics-16-00131-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9315/10819224/c78fc50e2b6b/pharmaceutics-16-00131-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9315/10819224/3d14b7b8a12a/pharmaceutics-16-00131-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9315/10819224/f6d85b8c48b9/pharmaceutics-16-00131-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9315/10819224/ac0958917b19/pharmaceutics-16-00131-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9315/10819224/d4d68bf6afa4/pharmaceutics-16-00131-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9315/10819224/c78fc50e2b6b/pharmaceutics-16-00131-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9315/10819224/3d14b7b8a12a/pharmaceutics-16-00131-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9315/10819224/f6d85b8c48b9/pharmaceutics-16-00131-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9315/10819224/ac0958917b19/pharmaceutics-16-00131-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9315/10819224/d4d68bf6afa4/pharmaceutics-16-00131-g005.jpg

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Chemistry and Art of Developing Lipid Nanoparticles for Biologics Delivery: Focus on Development and Scale-Up.

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[10]
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本文引用的文献

[1]
Characterization of lipid-based nanomedicines at the single-particle level.

Fundam Res. 2022-10-3

[2]
Lipid-Based Nanoparticles for Drug/Gene Delivery: An Overview of the Production Techniques and Difficulties Encountered in Their Industrial Development.

ACS Mater Au. 2023-8-21

[3]
A Route to Synthesize Ionizable Lipid ALC-0315, a Key Component of the mRNA Vaccine Lipid Matrix.

Russ J Bioorg Chem. 2023

[4]
Recent Progress of Lipid Nanoparticles-Based Lipophilic Drug Delivery: Focus on Surface Modifications.

Pharmaceutics. 2023-2-26

[5]
A review of conventional and emerging technologies for hydrogels sterilization.

Int J Pharm. 2023-3-5

[6]
Interaction Kinetics of Individual mRNA-Containing Lipid Nanoparticles with an Endosomal Membrane Mimic: Dependence on pH, Protein Corona Formation, and Lipoprotein Depletion.

ACS Nano. 2022-12-27

[7]
Atomic Force Microscopic Imaging of mRNA-lipid Nanoparticles in Aqueous Medium.

J Pharm Sci. 2023-3

[8]
Oxidative Stability in Lipid Formulations: a Review of the Mechanisms, Drivers, and Inhibitors of Oxidation.

AAPS PharmSciTech. 2022-5-20

[9]
An imidazole modified lipid confers enhanced mRNA-LNP stability and strong immunization properties in mice and non-human primates.

Biomaterials. 2022-7

[10]
A brief review on solid lipid nanoparticles: part and parcel of contemporary drug delivery systems.

RSC Adv. 2020-7-17

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