Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls
Ved Srivastava, "Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls "
English | ISBN: 1788014332 | 2019 | 571 pages | PDF | 12 MB
English | ISBN: 1788014332 | 2019 | 571 pages | PDF | 12 MB
Peptide therapy has become a key strategy of innovative drug development, however one of the potential barriers for approval of novel peptide drugs in the clinic is their deficiencies in clearly defined CMC strategy from the beginning of the clinical development plan. Peptide Therapeutics comprehensively outlines the critical process parameters for efficient manufacturing processes for the peptide drug substances and peptide drug products, the key challenges in quality control, emerging analytical tools, aligning chemistry manufacture and control with clinical trials and current regulatory guidelines. This book will be an asset not only as a reference book for peptide researchers engaged in the pharmaceutical manufacturing setting but also a valuable resource to research and development scientists and graduate students to understand the development and manufacturing process of peptide based medicine.