Kategoria BISAC: Medical >> Pharmacology

• Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it
• Covers method development, validation,...

A real-world guide to the production and manufacturing of biopharmaceuticals

While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging.

Written by a group of experts from industry and academia, the book focuses on real-world methods for...

The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other regulatory agencies. With the US providing more than 50% of the worldwide market for these products, every serious manufacturer of biosimilar biological drugs should be targeting US approval of their products. Thus, this book is strictly on FDA approval strategy.

This book deals with bioprocess engineering, which encompasses the design and development of equipment and processes for the manufacturing of products such as food, pharmaceuticals, chemicals, polymers and paper from biological materials. It also deals with studying various biotechnological processes used in industries for large scale production of biological products, for the optimization of yield. This work also incorporates significant treatment on biocatalysts and their applications in food industry, bioplastics production, conversion of agro waste and the importance of biotechnology...

What s the Deal with Biosimilars?

Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development.

Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This...