Description

Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability.

Features:

• Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugs
• Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized
• Addresses economic and practical considerations, unlike many other technical books
• Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies
• Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies

Chapter 15. Framework for the validation of mechanistic and hybrid models as Process Analytical tools in the pharmaceutical Industry

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