A Complete Guidebook on Automation in Biopharma Industrial Research

A Complete Guidebook on Automation in Biopharma Industrial Research: Fundamentals, Tools, and Case Studies is a reference for pharmaceutical scientists and entrepreneurs to leverage the latest technologies and best practices in increasing the productivity of research. The book covers the status of Industry 4.0 and 5.0 in biopharma on a global perspective in terms of data management, animal trials, bio-analytical techniques, clone development and management. The editors focus on automation of process and formulation development, identifying comprehensive approaches for automation of structural and functional characterization of biologics. The contents of the book are organized in 18 chapters. The first ones cover an introduction to the current state of the art in automation, followed by an overview of the path from bench to bedside of drugs and biologic therapies. Next, a roadmap to biopharma industry 5.0 is provided, followed by a chapter on automation and orchestration of activities. Chapter five covers data engineering, followed by clone development and automation challenges. The following chapters cover process and formulation development. Chapters nine and ten cover structural and functional characterization of biologics, respectively. Next a chapter is dedicated to process transfer and scale-up to production environment, followed by quality control. The final chapters cover standard development, PK-PD analysis, R&D package generation, life-cycle management, CMC digital strategy, and case studies. A Complete Guidebook on Automation in Biopharma Industrial Research: Fundamentals, Tools, and Case Studies present an integrated and up-to-date view into the automation efforts happening in the Biopharma industry. Combining insights from academic and corporate research, this reference is uniquely positioned to help pharmaceutical scientists and entrepreneurs in this space to increase productivity and reproducibility in their endeavors.

• Provides the latest advancements, best practices, and case studies in biopharma automation
• Addresses automation challenges such as system integration, complex data structures, and data flows between applications
• Covers experiences from academia and biopharma industrial research, combined with digitization and advanced automation, drive innovative solutions to overcome industry challenges