The concepts, applications, and practical issues of Quality by Design
Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process.
Quality by Design: Perspectives and Case Studies presents the first systematic approach to...
The concepts, applications, and practical issues of Quality by Design
Quality by Design (QbD) is a new framework currently being implemented...
Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture...
Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes...
In the wake of rapid advances in genetic technologies, new products continue to be developed to help improve human health and quality of life. Summarizing state-of-the art bioprocessing methods, Novel Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts presents a concise exploration of the latest developments in bioprocessing for applications in both the biopharmaceutical and biochemical industries. Including case study reviews of six milestone byproducts, the authors provide industrial and academic researchers and development scientists and students with a...
In the wake of rapid advances in genetic technologies, new products continue to be developed to help improve human health and quality of life. Summari...