Key Points and Considerations in Biopharmaceutical Product Development

Description

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Product ID: 1159

Publisher: Johokiko

Publication Date: 2026-07-27

English Summary

This comprehensive book consolidates essential information on drug discovery research, safety evaluation, manufacturing, quality assurance, regulatory affairs, patent strategies, and the use of AI in biopharmaceuticals. It is beneficial for professionals involved in various aspects of biopharmaceutical development, including quality assurance, manufacturing, quality control, regulatory affairs, research and development, and intellectual property.

Contents / Coverage

• Chapter 1: Current Status and Prospects of Advanced Modality Research and Development in Biopharmaceuticals
• Chapter 2: Safety Evaluation of Biopharmaceuticals
• Chapter 3: Key Points in Establishing Manufacturing Processes for Biopharmaceuticals
• Chapter 4: Practical Knowledge and Fundamentals of Stability Testing for Biopharmaceuticals
• Chapter 5: Key Points in Quality Assurance and Management of Biopharmaceuticals
• Chapter 6: Key Points in Preparing CTD for Biopharmaceuticals
• Chapter 7: Development Strategies Utilizing Regulatory Frameworks like Orphan Drug and Breakthrough Therapy Designations
• Chapter 8: Considerations for Patent Strategies in Biopharmaceuticals
• Chapter 9: Overview and Recent Developments in Biosimilars
• Chapter 10: Utilization and Challenges of AI and Robotics in Biopharmaceutical Development

Why This May Matter Internationally

The book addresses global standards and practices in biopharmaceutical development, making it relevant for professionals and organizations involved in drug development and regulatory compliance worldwide.

Keywords: biopharmaceuticals,drug development,quality assurance,regulatory affairs,patent strategy,AI in pharma