John Rijo, Monpara Jasmin, Swaminathan Shankar, Kalhapure Rahul
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.
Pharmaceutics. 2024 Jan 19;16(1):131. doi: 10.3390/pharmaceutics16010131.
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.
脂质纳米颗粒（LNPs）作为递送多种治疗剂的主要载体已受到广泛关注。生物制品在临床环境中已占据稳固地位，并且开发新型变体的期望也在增加。这些产品主要包括治疗性蛋白质、核酸和信使核糖核酸。开发能够克服其局限性的高效基于LNP的生物制品递送系统仍然是一种非常有利的制剂策略。此外，鉴于其尺寸小、生物相容性和可生物降解性，LNPs能够有效地将治疗部分转运到细胞中，而不会产生明显的毒性和不良反应。这对于现有和即将出现的生物制药尤为关键，因为大分子作为一个整体存在若干可被LNPs克服的挑战。本综述描述了用于递送生物制品的LNP技术，并总结了用于生物制品LNP开发的脂质在化学、制造和表征方面的进展。最后，我们对LNP技术的潜在机遇和当前挑战提出了看法。
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