Biopharmaceutical Manufacturing: From Process Development to Commercial Production

This course provides a comprehensive overview of Good Manufacturing Practice (GMP) production, quality management, and regulatory compliance in biopharmaceutical manufacturing. Students will develop a strong foundation in upstream and downstream processing, exploring key techniques for process optimization, scale-up, and ensuring product consistency. The course covers essential topics such as process development, product characterization, Quality by Design (QbD) principles, risk management, and quality assurance strategies critical to regulatory compliance. Beyond technical concepts, students will examine facility design considerations, outsourcing strategies, and vendor management to understand the broader operational landscape of biopharmaceutical manufacturing. Each week, students will take on different industry roles, engaging in hands-on decision-making and problem-solving exercises. Through these interactive simulations, they will gain practical insights into navigating manufacturing complexities, regulatory expectations, and the challenges of maintaining high-quality standards in a rapidly evolving industry.