Therapeutic Peptides Encapsulated into Lipid-Based Nanovesicles: Scaling from Lab to Plant

Abstract

Lipid-based peptide-encapsulated nanovesicles represent a cutting-edge approach in drug delivery systems, offering enhanced stability, targeted delivery, and controlled release of therapeutic peptides. This review explores the comprehensive science and techniques behind the robust formulation and analytical methods for these nanovesicles, spanning from lab-scale research to large- scale manufacturing. Critical aspects include lipid selection, detailing how the choice of lipids impacts the stability and efficacy of the nanovesicles, and various peptide encapsulation techniques, emphasizing methods to achieve high encapsulation efficiency and controlled release. Key processes in vesicle formation, such as thin film hydration, sonication, and microfluidics, are discussed to highlight their roles in producing nanovesicles with consistent size and morphology. The importance of stability studies, including physical, chemical, and thermal assessments, is underscored. Analytical techniques such as Dynamic Light Scattering (DLS), Zeta Potential measurement, High-Performance Liquid Chromatography (HPLC), and Mass Spectrometry (MS) are detailed, showcasing their crucial roles in characterizing nanovesicles and ensuring their quality, safety, and efficacy for pharmaceutical use. The review addresses the challenges and solutions associated with scaling up production, including maintaining consistent product quality, optimizing manufacturing processes, and controlling production costs. It also navigates the regulatory landscape, discussing the stringent guidelines set by agencies such as the FDA and EMA and the necessity of strategic regulatory planning to facilitate market approval. This comprehensive review aims to serve as an in-depth resource for experts in the field, aiding in the translation of lipid-based peptide-encapsulated nanovesicle formulations from bench to bedside, ultimately enhancing therapeutic outcomes and expanding treatment options for various disease. Key Words: Peptide, Amino acid, Degradation, Pharmacokinetics, Peptide encapsulation, drug delivery systems, Peptide Characterization