Protein and Peptide Therapeutics: Stability Challenges, Regulatory Demands, and Innovative Formulation Solutions for Enhanced Clinical Effectiveness.

IF 1.1 4区生物学 Q4 BIOCHEMISTRY & MOLECULAR BIOLOGY

Protein and Peptide Letters Pub Date : 2025-07-11 DOI:10.2174/0109298665375151250626124048

Megha Patel, Dhruv Parikh, Akshay Parihar, Bhupendra Prajapati, Meenakshi B Patel, Sagar Salave, Ravi Patel, Rishabha Malviya, Rahul Maheshwari, Dignesh Khunt

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引用次数: 0

Abstract

Proteins and peptides play a crucial role in biological functions and contemporary therapeutic approaches; however, their clinical effectiveness is frequently hindered by swift renal clearance and enzymatic degradation. Peptides possess structured amino acid sequences that facilitate targeted drug delivery and enhance patient adherence. In contrast, proteins demonstrate intricate stability behaviors affected by pH and environmental conditions, requiring careful formulation strategies. Addressing these challenges necessitates a comprehensive understanding of stability and regulatory requirements. Regulatory agencies, including the FDA, EMA, and PMDA, require comprehensive stability testing per guidelines such as ICH Q5C and ICH Q1A(R2). This ensures meticulous management of factors such as temperature control, formulation optimization, and aggregation mitigation. Stability enhancement requires the application of innovative techniques, including protein engineering, lyoprotection, and nanoparticle encapsulation, in conjunction with ongoing quality monitoring. Integrating scientific expertise with regulatory standards enables researchers and pharmaceutical manufacturers to develop safe, effective, and compliant protein and peptide therapeutics for various patient populations.

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蛋白质和多肽治疗：稳定性挑战，监管要求，以及提高临床有效性的创新配方解决方案。

蛋白质和多肽在生物功能和当代治疗方法中起着至关重要的作用；然而，它们的临床效果经常受到肾脏快速清除和酶降解的阻碍。多肽具有结构化的氨基酸序列，有利于靶向药物的递送和增强患者的依从性。相比之下，蛋白质表现出复杂的稳定性行为，受pH和环境条件的影响，需要谨慎的配方策略。应对这些挑战需要全面了解稳定性和监管要求。包括FDA、EMA和PMDA在内的监管机构要求根据ICH Q5C和ICH Q1A（R2）等指南进行全面的稳定性测试。这确保了对温度控制、配方优化和聚合减缓等因素的细致管理。稳定性增强需要创新技术的应用，包括蛋白质工程、lyo保护和纳米颗粒封装，并结合持续的质量监测。将科学专业知识与监管标准相结合，使研究人员和制药商能够为各种患者群体开发安全、有效和合规的蛋白质和肽疗法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Protein and Peptide Letters 生物-生化与分子生物学

CiteScore

2.90

自引率

0.00%

发文量

审稿时长

2 months

期刊介绍： Protein & Peptide Letters publishes letters, original research papers, mini-reviews and guest edited issues in all important aspects of protein and peptide research, including structural studies, advances in recombinant expression, function, synthesis, enzymology, immunology, molecular modeling, and drug design. Manuscripts must have a significant element of novelty, timeliness and urgency that merit rapid publication. Reports of crystallization and preliminary structure determination of biologically important proteins are considered only if they include significant new approaches or deal with proteins of immediate importance, and preliminary structure determinations of biologically important proteins. Purely theoretical/review papers should provide new insight into the principles of protein/peptide structure and function. Manuscripts describing computational work should include some experimental data to provide confirmation of the results of calculations. Protein & Peptide Letters focuses on: Structure Studies Advances in Recombinant Expression Drug Design Chemical Synthesis Function Pharmacology Enzymology Conformational Analysis Immunology Biotechnology Protein Engineering Protein Folding Sequencing Molecular Recognition Purification and Analysis