Niazi S. Biopharmaceutical Manufacturing. Vol 1. Regulatory Processes 2021

Textbook in PDF format

This two-volume set provides a comprehensive guide to the essential aspects of commercial biopharmaceutical manufacturing. Covering the planning, layout and operation of successful commercial manufacturing, the aim of the books is to enable innovations, new drug development, and make affordable biological drugs available to patients worldwide. This volume covers the regulatory processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product for commercial distribution, including areas of current GMP, registration, and legal and ethical considerations. Emerging trends in the technology and regulatory compliance are also discussed, with advice on establishing efficient manufacturing facilities. Intended for practitioners in the commercial biopharmaceutical manufacturing industry, the text is an ideal resource for practitioners looking to develop their ability to manufacture biopharmaceutical products at a large scale.
Introduction to biopharmaceuticals
Antibody biopharmaceuticals
Gene and cell therapy
Formulation of biopharmaceuticals
Biopharmaceutical development cycle
Biosimilar biopharmaceuticals
Intellectual property issues for scientists