Elements of Biopharmaceutical Production Series, Fourth Edition
Item Number: BIOB112
This book is a practical reference manual for professionals involved in biotechnology and biopharmaceutical manufacturing practices, contract manufacturing services, large scale processing development, integrated solutions, characterization and validation and biotechnological products.
This guide to understanding the manufacturing of biopharmaceuticals is ideal for pharmaceutical professionals involved in advances in large-scale pharmaceutical production and manufacturing. The 4th edition of this book was compiled from a variety or resource materials supplied by BioPharm International magazine, led by Anurag Rathore, which integrates the science and business of biopharmaceutical research, development and manufacturing.
An incredible amount of analytical testing is needed to support a biopharmaceutical product from discovery, development, and clinical trials, through manufacturing and marketing. Understanding the production of medical drugs such as biopharmaceuticals is central to this book.
Manufacturers use proteins (which include antibodies), living microorganisms, and nucleic acids. Biopharmaceuticals began being used for therapeutic or diagnostic purposes in 1982. Most biopharmaceutical products are pharmaceuticals processed from life forms. The manufacture biopharmaceutical products must comply with GMP (Good Manufacturing Practice) pharmaceutical and drug regulations of the Food and Drug Administration.
This biotechnology technology book is a must have for anyone involved in the following activities.
- Biotechnology and Pharmaceutical
- Regulatory Affairs
- Regulatory Practices for Biopharmaceutical Production
- Pharmaceutical Research
- Manufacturing Operations
- Pharmaceutical and Process Development
- Chemical, Biochemical and Synthesis Development
- Analytical Development
- Quality Management
- Validation and Qualification Management
- Quality Management
The conception of the Elements of Biopharmaceutical Manufacturing Series came out of a need of continued professional and technical growth for those that are involved in the various activities related to manufacturing of biotech products.
The series includes articles that focus on various topics:
- Quality by design (QbD)
- Process Analytical Technology (PAT)
- Economic Analysis of Biotech Processes
Written in an easy to read format and intended to provide a review of best practices, the 4th Edition now contains nearly 400 pages!
This is a must have for anyone involved in validation activities or planning to start validation activities.