Coverart for item
The Resource Peptide therapeutics : strategy and tactics for chemistry, manufacturing, and controls, editor: Ved Srivastava

Peptide therapeutics : strategy and tactics for chemistry, manufacturing, and controls, editor: Ved Srivastava

Label
Peptide therapeutics : strategy and tactics for chemistry, manufacturing, and controls
Title
Peptide therapeutics
Title remainder
strategy and tactics for chemistry, manufacturing, and controls
Statement of responsibility
editor: Ved Srivastava
Contributor
Editor
Subject
Language
eng
Summary
Peptide Therapeutics is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about Chemistry Manufacture and Control (CMC), and facilitating the development and manufacture of peptide-based drugs
Member of
Cataloging source
UKRSC
Dewey number
615.19
Index
index present
LC call number
RS431.P38
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorName
Srivastava, Ved
http://library.link/vocab/subjectName
  • Peptide drugs
  • Peptide drugs
Label
Peptide therapeutics : strategy and tactics for chemistry, manufacturing, and controls, editor: Ved Srivastava
Instantiates
Publication
Note
Includes index
Antecedent source
unknown
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Contents
  • Cover; Preface; Editor Biography; Contents; Chapter 1 Regulatory Considerations for Peptide Therapeutics; 1.1 Introduction; 1.2 Peptide Quality Assessment at the FDA; 1.3 Overview of the Current Drug Approval Process Employed for Peptide Applications; 1.3.1 The New Drug Application Assessment Process; 1.3.2 Abbreviated New Drug Application Assessment Process; 1.3.3 Post-approval Activities and Life-cycle Management; Disclaimer; Acknowledgements; References; Chapter 2 Regulatory Perspective on Synthetic Peptides in Europe; 2.1 Introduction; 2.2 European Regulatory Network
  • 2.3 Guidelines on the Quality of Human Medicines2.4 Overall Control Strategy; 2.5 Documentation in Dossier of Marketing Authorization; 2.6 European Pharmacopoeia (Ph. Eur.); 2.7 Technical Guide for the Elaboration of Monographson Synthetic Peptides and Recombinant DNA Proteins; 2.8 Information to be Provided in Module 3 for Synthetic Peptides (New Active Substances); 2.9 Considerations for Peptides Conjugates; 2.10 Medicinal Product Considerations; 2.11 Synthetic Peptide Vaccines
  • 2.12 Synthetic Peptide Development Programmes Using a Biological Medicinal Product as a European Reference Medicinal Product2.13 Requirements for Clinical Trial Applications; 2.14 Scientific Advice and European Initiatives for Early Access Approaches; 2.15 Conclusion; Disclaimer; References; Chapter 3 Biological and Immunogenicity Evaluation Strategy for Therapeutic Peptides: Chemistry, Manufacturing and Controls Perspective; 3.1 Introduction; 3.2 Biological Evaluation; 3.2.1 Strategy for Assay Development; 3.2.2 Considerations for Potency Assay Design and Validation
  • 3.3 Assay Development and Validation3.3.1 Ex Vivo Bioassays; 3.3.2 In Vitro Bioassays; 3.3.3 Assay Readouts; 3.3.4 Assay Design; 3.3.5 Cell Line Selection; 3.3.6 Factors Influencing the Assays; 3.3.7 Standards and Controls; 3.3.8 Design of Experiments and Data Analysis; 3.3.9 Assay Validation; 3.4 Specific Assays of Peptide-based Vaccines; 3.4.1 HLA Binding Assays; 3.5 Immunogenicity Evaluation; 3.5.1 Antibody Testing Strategy; 3.5.2 Risk-based Antibody Testing; 3.5.3 Binding Antibody Testing; 3.5.4 Sandwich Immunoassay; 3.5.5 Mass-related Immunoassay; 3.5.6 SPR; 3.5.7 Mass Spectrometry
  • 3.5.8 Cytometry-based Immunoassays3.5.9 Acid Dissociation-based Assay for Drug Interference; 3.5.10 Considerations for Binding Antibody Immunoassays; 3.6 Neutralizing Anti-drug Antibody Testing; 3.6.1 Cell-based Neutralizing Antibody Assay; 3.6.2 Cell Line Selection; 3.6.3 Assay Endpoints for Cell-based Assays; 3.6.4 Cell-based Assay Formats; 3.6.5 Considerations for Ligand-binding Antibody Bioassays; 3.7 Specific Assays for Peptide-based Vaccines; 3.7.1 Enzyme-linked Immunospot (ELISpot) Assay; 3.7.2 Surface and Intracellular Staining; 3.8 Conclusion; References
Control code
on1114305639
Dimensions
unknown
Extent
1 online resource (544 pages).
File format
unknown
Form of item
online
Isbn
9781788016445
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Quality assurance targets
unknown
Sound
unknown sound
Specific material designation
remote
Label
Peptide therapeutics : strategy and tactics for chemistry, manufacturing, and controls, editor: Ved Srivastava
Publication
Note
Includes index
Antecedent source
unknown
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Contents
  • Cover; Preface; Editor Biography; Contents; Chapter 1 Regulatory Considerations for Peptide Therapeutics; 1.1 Introduction; 1.2 Peptide Quality Assessment at the FDA; 1.3 Overview of the Current Drug Approval Process Employed for Peptide Applications; 1.3.1 The New Drug Application Assessment Process; 1.3.2 Abbreviated New Drug Application Assessment Process; 1.3.3 Post-approval Activities and Life-cycle Management; Disclaimer; Acknowledgements; References; Chapter 2 Regulatory Perspective on Synthetic Peptides in Europe; 2.1 Introduction; 2.2 European Regulatory Network
  • 2.3 Guidelines on the Quality of Human Medicines2.4 Overall Control Strategy; 2.5 Documentation in Dossier of Marketing Authorization; 2.6 European Pharmacopoeia (Ph. Eur.); 2.7 Technical Guide for the Elaboration of Monographson Synthetic Peptides and Recombinant DNA Proteins; 2.8 Information to be Provided in Module 3 for Synthetic Peptides (New Active Substances); 2.9 Considerations for Peptides Conjugates; 2.10 Medicinal Product Considerations; 2.11 Synthetic Peptide Vaccines
  • 2.12 Synthetic Peptide Development Programmes Using a Biological Medicinal Product as a European Reference Medicinal Product2.13 Requirements for Clinical Trial Applications; 2.14 Scientific Advice and European Initiatives for Early Access Approaches; 2.15 Conclusion; Disclaimer; References; Chapter 3 Biological and Immunogenicity Evaluation Strategy for Therapeutic Peptides: Chemistry, Manufacturing and Controls Perspective; 3.1 Introduction; 3.2 Biological Evaluation; 3.2.1 Strategy for Assay Development; 3.2.2 Considerations for Potency Assay Design and Validation
  • 3.3 Assay Development and Validation3.3.1 Ex Vivo Bioassays; 3.3.2 In Vitro Bioassays; 3.3.3 Assay Readouts; 3.3.4 Assay Design; 3.3.5 Cell Line Selection; 3.3.6 Factors Influencing the Assays; 3.3.7 Standards and Controls; 3.3.8 Design of Experiments and Data Analysis; 3.3.9 Assay Validation; 3.4 Specific Assays of Peptide-based Vaccines; 3.4.1 HLA Binding Assays; 3.5 Immunogenicity Evaluation; 3.5.1 Antibody Testing Strategy; 3.5.2 Risk-based Antibody Testing; 3.5.3 Binding Antibody Testing; 3.5.4 Sandwich Immunoassay; 3.5.5 Mass-related Immunoassay; 3.5.6 SPR; 3.5.7 Mass Spectrometry
  • 3.5.8 Cytometry-based Immunoassays3.5.9 Acid Dissociation-based Assay for Drug Interference; 3.5.10 Considerations for Binding Antibody Immunoassays; 3.6 Neutralizing Anti-drug Antibody Testing; 3.6.1 Cell-based Neutralizing Antibody Assay; 3.6.2 Cell Line Selection; 3.6.3 Assay Endpoints for Cell-based Assays; 3.6.4 Cell-based Assay Formats; 3.6.5 Considerations for Ligand-binding Antibody Bioassays; 3.7 Specific Assays for Peptide-based Vaccines; 3.7.1 Enzyme-linked Immunospot (ELISpot) Assay; 3.7.2 Surface and Intracellular Staining; 3.8 Conclusion; References
Control code
on1114305639
Dimensions
unknown
Extent
1 online resource (544 pages).
File format
unknown
Form of item
online
Isbn
9781788016445
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Quality assurance targets
unknown
Sound
unknown sound
Specific material designation
remote

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