Peptide Therapeutics最新文献_第2页

Chapter 5. Peptide Manufacturing Methods and Challenges 第五章。肽制造方法和挑战

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00111

S. Kota

引用次数: 1

Chapter 13. Assessing the Impact of Functional Excipients on Peptide Drug Product Attributes During Pharmaceutical Development 第13章。在药物开发过程中评估功能性辅料对多肽药物产品属性的影响

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00472

Suzanne M. D'Addio, J. Bothe, E. Walsh, Marian E. Gindy

{"title":"Chapter 13. Assessing the Impact of Functional Excipients on Peptide Drug Product Attributes During Pharmaceutical Development","authors":"Suzanne M. D'Addio, J. Bothe, E. Walsh, Marian E. Gindy","doi":"10.1039/9781788016445-00472","DOIUrl":"https://doi.org/10.1039/9781788016445-00472","url":null,"abstract":"Achieving market approval of a new peptide therapeutic requires phase-appropriate demonstration of product safety, efficacy and quality across all stages of development, including raw materials, drug substance and drug product manufacture, product distribution and shelf-life. Of particular importance is the definition of a drug product formulation that meets requirements as defined by the Quality Target Product Profile (QTPP) and mitigates peptide-specific Chemistry, Manufacturing and Controls (CMC) liabilities. Peptide drug product formulations can range widely in complexity, but often require the inclusion of excipients that are selected to perform a number of functions, such as buffering pH, preserving sterility, mitigating chemical and/or physical instabilities of the peptide active substance or controlling the rate of peptide drug release upon administration in people. The choice of excipient(s) and composition(s) can impact multiple drug product attributes, which necessitates appropriate formulation characterization and data-driven decision-making regarding excipient use throughout development and ultimately in the final drug product. This chapter briefly surveys categories of excipients employed in therapeutic peptide formulation development, highlights guidance and regulations related to the selection and evaluation of such excipients and discusses the assessment and justification of excipient use in formulations, from discovery through development, with a focus on peptide-specific challenges in parenteral formulations.","PeriodicalId":20009,"journal":{"name":"Peptide Therapeutics","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77276767","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 2. Regulatory Perspective on Synthetic Peptides in Europe 第二章。合成多肽在欧洲的监管前景

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00031

René Thürmer

引用次数: 0

Chapter 10. Mass Spectrometric Analysis for the Quality Control of Peptide Conjugate Therapeutics 第十章。质谱分析在多肽偶联药物质量控制中的应用

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00343

O. Chahrour, Anna Meljon, D. Cobice

{"title":"Chapter 10. Mass Spectrometric Analysis for the Quality Control of Peptide Conjugate Therapeutics","authors":"O. Chahrour, Anna Meljon, D. Cobice","doi":"10.1039/9781788016445-00343","DOIUrl":"https://doi.org/10.1039/9781788016445-00343","url":null,"abstract":"The development of suitable analytical tools is required to study the stability, manufacturability and bio-performance of peptide conjugate therapeutics. Mass spectrometric analysis provides essential knowledge for understanding and building the critical quality attributes and regulatory specifications of peptides. The purpose of this chapter is to provide an overview/update of mass spectrometric techniques (e.g. ion stripping and isotopic labelling) that are employed for the analytical characterization and quantitation of peptides and their conjugates such as PEGylated peptides and antibody–drug conjugates. Advances in high-resolution mass spectrometry (HRMS) have considerably increased the quality of analytical data on antibody–peptide drug conjugates [e.g. average drug-to-antibody ratio (DAR), drug loading distribution, unconjugated drug and impurity characterization via peptide mapping] that can be used for product and process development, lot release and stability testing. Similarly, the quality of PEGylated peptides can be evaluated via qualitative and quantitative mass spectrometric analysis to ensure that the PEGylated therapeutics have the desired properties such as molecular mass and polydispersity. In addition, relative or absolute mass spectrometric-based quantitation of peptides/peptide conjugates is very useful for assessing stability, label claim and batch-to-batch variability. Different strategies exploiting stable isotope labelling and isotope dilution are possible, each having specific strengths and weaknesses. Inductively coupled plasma mass spectrometry (ICP-MS) has recently emerged as a complementary technique to the previous methods allowing absolute protein quantification using suitable elemental-based tags.","PeriodicalId":20009,"journal":{"name":"Peptide Therapeutics","volume":"46 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82235486","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 6. Economic and Environmental Factors Affecting the Sustainability of Peptide Therapeutic Manufacturing 第六章。影响多肽治疗生产可持续性的经济和环境因素

Peptide Therapeutics Pub Date : 2019-08-16 DOI: 10.1039/9781788016445-00151

E. Lax, T. Shah

引用次数: 2

Editor Biography 编辑传记

Peptide Therapeutics Pub Date : 2019-01-01 DOI: 10.1016/b978-0-12-815723-7.00020-1

H. Ammari

引用次数: 0