Handbook of biological therapeutic proteins : regulatory, manufacturing, testing, and patent issues

Handbook of biological therapeutic proteins : regulatory, manufacturing, testing, and patent issues /

"Since 1972 when recombinant engineering was invented, over 500 therapeutic proteins have been approved. Today, biological drugs constitute almost 70% of all new drugs and are of biological origin. The first edition of this book dealt with biosimilars, the second focuses on new drugs yet limits...

Full description

Saved in:
Bibliographic Details
Main Author: Niazi, Sarfaraz, 1949- (Author)
Format: Electronic eBook
Language:English
Published: Boca Raton : CRC Press, 2024.
Edition:Second edition.
Subjects:
Pharmaceutical technology.
Pharmaceutical industry.
Recombinant Proteins > therapeutic use
Biosimilar Pharmaceuticals
Technology, Pharmaceutical
Drug Industry
Online Access:Full text (Wentworth users only)
Table of Contents:
  • Biosimilar Biopharmaceuticals
  • Regulatory Requirements
  • Development Master Plan
  • Trends in Recombinant Proteins Manufacturing
  • Analytical Assessment
  • Clinical Pharmacology Assessment
  • Clinical Immunogenicity Assessment
  • Clinical Efficacy Assessment
  • Recombinant Manufacturing System
  • Upstream Processing
  • Downstream Process
  • Formulation of Biopharmaceuticals
  • Quality and Compliance Systems
  • Intellectual Property Issues for Scientists
  • Advances in Biomanufacturing.

Similar Items