Peptide Therapeutics最新文献

Peptide Therapeutics: Fundamentals of Design, Development, and Delivery 肽疗法:设计、开发和交付的基础

Peptide Therapeutics Pub Date : 2022-01-01 DOI: 10.1007/978-3-031-04544-8

引用次数: 1

Chapter 11. Determination of the Identity, Content and Purity of Therapeutic Peptides by NMR Spectroscopy 第十一章。核磁共振光谱法测定治疗肽的性质、含量和纯度

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00381

E. Kellenbach, T. Rundlöf

引用次数: 0

Chapter 14. Formulations of Microspheres and Nanoparticles for Peptide Delivery 第14章。肽递送用微球和纳米颗粒的配方

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00503

Jyothi Thundimadathil

{"title":"Chapter 14. Formulations of Microspheres and Nanoparticles for Peptide Delivery","authors":"Jyothi Thundimadathil","doi":"10.1039/9781788016445-00503","DOIUrl":"https://doi.org/10.1039/9781788016445-00503","url":null,"abstract":"Delivery of peptide drugs using microspheres has been used in a number of commercial drug formulations and this area continues to grow to overcome potential challenges with the intrinsic properties of peptides and proteins. The use of microparticles as an alternative delivery system for peptide and protein drugs has attracted substantial interest in recent years. Encapsulation of peptides or proteins in such carrier systems during formulation could potentially benefit the drug profile. Several examples of peptide and protein delivery using microsphere formulations are included. Different types of microspheres, their preparation, characterization, factors affecting drug delivery and mechanism of drug delivery are discussed. Peptide drugs on the market such as leuprolide, triptorelin, octreotide, lanreotide, human growth hormone, buserelin, abarelix and exenatide use microsphere-based formulations. Drug nanoparticle formulations have been demonstrated to show increased solubility and thus enhanced bioavailability, with additional ability to cross the blood–brain barrier, enter the pulmonary system and be absorbed through the tight junctions of endothelial cells of the skin, primarily owing to their small size and large surface area. Nanoparticle formulations based on liposomes, polymeric micelles, polymeric nanoparticles, nanoemulsions, nanogels, dendrimers, fullerenes, carbon nanotubes, magnetic nanoparticles, metal nanoparticles and quantum dots have been extensively discussed in the literature. Selected examples of peptide/protein nanoparticle formulations are discussed with special emphasis on various delivery routes and delivery mechanisms.","PeriodicalId":20009,"journal":{"name":"Peptide Therapeutics","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87642475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 2

Chapter 7. A Holistic Quality Control Strategy for Peptide Active Pharmaceutical Ingredients (APIs) 第七章。多肽原料药的整体质量控制策略

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00194

Aleksander Świetłow, Asher Lower

引用次数: 1

Chapter 4. Chemistry, Manufacturing and Controls: Active Pharmaceutical Ingredient and Drug Product 第四章。化学，制造和控制:活性药物成分和药品

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00097

Prem Ramiya

引用次数: 0

Chapter 12. Transport, Stability and Delivery Considerations for the Design of Peptide Drugs 第十二章。多肽药物设计的运输、稳定性和递送考虑

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00421

T. Sawyer, J. Hochman, Suzanne M. D'Addio, B. Sherborne, Marian E. Gindy

{"title":"Chapter 12. Transport, Stability and Delivery Considerations for the Design of Peptide Drugs","authors":"T. Sawyer, J. Hochman, Suzanne M. D'Addio, B. Sherborne, Marian E. Gindy","doi":"10.1039/9781788016445-00421","DOIUrl":"https://doi.org/10.1039/9781788016445-00421","url":null,"abstract":"The biopharmaceutical industry is experiencing renewed interest in the discovery and development of peptide therapeutics, enabled in part by advances in synthetic processes, phage display technologies and combinatorial libraries that have permitted the rapid design, identification and evaluation of potential new peptide actives. With more than 100 peptide drugs already on the market as of 2018, garnering collective sales in excess of $20 billion, the promise of peptide medicines is a compelling one. Yet broad realization of peptide drugs remains elusive: limitations in biological delivery, including short half-life, rapid metabolism, proteolytic cleavage, poor permeation across biological membranes and a propensity for chemical and physical degradation, present significant challenges to peptide drug development. This chapter addresses key stability and pharmacokinetic considerations for the development of peptide drugs, identifies approaches and methodologies for their assessments in preclinical research and development and discusses current and emerging chemistry strategies to address such liabilities through predictive molecular design.","PeriodicalId":20009,"journal":{"name":"Peptide Therapeutics","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89668409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Chapter 3. Biological and Immunogenicity Evaluation Strategy for Therapeutic Peptides: Chemistry, Manufacturing and Controls Perspective 第三章。治疗肽的生物学和免疫原性评价策略:化学、制造和控制的观点

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00069

A. Kaliyaperumal

{"title":"Chapter 3. Biological and Immunogenicity Evaluation Strategy for Therapeutic Peptides: Chemistry, Manufacturing and Controls Perspective","authors":"A. Kaliyaperumal","doi":"10.1039/9781788016445-00069","DOIUrl":"https://doi.org/10.1039/9781788016445-00069","url":null,"abstract":"Assessment of the immunogenicity of peptides used for therapeutic purposes along with measurement of their biological activity is essential to evaluating the safety of therapeutic peptides. Accurate determination of the potency (biological activity) and evaluation of the immunogenicity of peptide-based therapeutic drugs for use in humans are crucial to their efficacy and safety. The assays used in determining the biological activity must closely follow the mechanism of action. A panel of assays can be used for testing the activity of a molecule. Several cell-based assay methods with a wide range of readouts can be used in the evaluation. These readouts can be cellular responses, signal transduction events, gene transcription reporter assays and/or ligand–receptor-binding cell-based assays using flow cytometry. Additionally, it is important to evaluate the immunogenic potential of the biologics in an appropriate fashion using a clearly defined strategy and clinical trials. The studies must include the appropriate risk assessment procedures and evaluation of immunogenicity using validated methods. The immune responses against the therapeutic biologics can be studied using various methodologies. These include enzyme-linked immunosorbent assay (ELISA), surface plasmon resonance (SPR), chemiluminescence and flow cytometry assays for binding antibodies and cell-based assays for neutralizing antibodies. The immune responses to the biologics can vary widely in various cross-sections of the population, hence a combination of techniques is necessary to evaluate fully the immunogenic potential of the biologics. This chapter outlines various commonly used technology platforms and their merits and shortcomings.","PeriodicalId":20009,"journal":{"name":"Peptide Therapeutics","volume":"61 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87544735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Chapter 1. Regulatory Considerations for Peptide Therapeutics 第1章。多肽治疗的监管考虑

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00001

Larisa C Wu

引用次数: 4

Chapter 8. Higher-order Structure Characterization and Comparability Assessments for Peptides 第八章。多肽的高阶结构表征和可比性评价

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00274

Renáta Varga, A. Rane

{"title":"Chapter 8. Higher-order Structure Characterization and Comparability Assessments for Peptides","authors":"Renáta Varga, A. Rane","doi":"10.1039/9781788016445-00274","DOIUrl":"https://doi.org/10.1039/9781788016445-00274","url":null,"abstract":"There is increased interest in peptides in pharmaceutical research and development owing to their superior characteristics over small molecules in terms of high selectivity, efficacy and safety and also over large biomolecules in terms of less complexity and the associated cost. However, peptides sit between these two well-studied and understood groups of therapeutics, challenging scientists in designing characterization and comparability studies to cover all analytical aspects. There is a vital part of chemistry, manufacturing and control (CMC) in peptide drug development describing the structure and characterization of the molecule itself and in the case of a generic development comparing its structure with that of a reference product. Considering the complexity in terms of multiple structural elements of peptides, similarly to proteins, these sections highlight the higher-order structure of peptides during development. This chapter focuses on the description of the higher-order structure elements of peptides and the potential analytical methodologies for characterization and to present the main differences and challenges when studying peptides compared with large proteins. At the end of the chapter, a recommended study design of higher-order structure characterization and comparability of generic peptides is presented. Note that in this chapter peptides are considered to be, by definition, to contain fewer than 100 amino acid residues and are well distinguished from proteins.","PeriodicalId":20009,"journal":{"name":"Peptide Therapeutics","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82006425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Chapter 9. Impurity Characterization and Quantification by Liquid Chromatography–High-resolution Mass Spectrometry 第9章。液相色谱-高分辨率质谱法杂质表征与定量

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00313

K. Zeng, M. Boyne, Timothy K. Toby, C. Ruzicka

引用次数: 0