Peptide therapeutics : strategy and tactics for chemistry, manufacturing, and controls [E-Book] / editor: Ved Srivastava.
Srivastava, Ved, (editor)
Cambridge : Royal Society of Chemistry, 2019
1 online resource (544 pages)
Drug discovery ; 72
Full Text
Table of Contents:
  • Regulatory Considerations for Peptide Therapeutics
  • Regulatory Perspective on Synthetic Peptides in Europe
  • Biological and Immunogenicity Evaluation Strategy for Therapeutic Peptides: Chemistry, Manufacturing and Controls Perspective
  • Chemistry, Manufacturing and Controls: Active Pharmaceutical Ingredient and Drug Product
  • Peptide Manufacturing Methods and Challenges
  • Economic and Environmental Factors Affecting the Sustainability of Peptide Therapeutic Manufacturing
  • A Holistic Quality Control Strategy for Peptide Active Pharmaceutical Ingredients (APIs)
  • Higher-order Structure Characterization and Comparability Assessments for Peptides
  • Impurity Characterization and Quantification by Liquid Chromatography–High-resolution Mass Spectrometry
  • Mass Spectrometric Analysis for the Quality Control of Peptide Conjugate Therapeutics
  • Determination of the Identity, Content and Purity of Therapeutic Peptides by NMR Spectroscopy
  • Transport, Stability and Delivery Considerations for the Design of Peptide Drugs
  • Assessing the Impact of Functional Excipients on Peptide Drug Product Attributes During Pharmaceutical Development
  • Formulations of Microspheres and Nanoparticles for Peptide Delivery