Program Overview

Biopharmaceutical Manufacturing: From Process Development to Commercial Production

Course Overview

This course offers an overview of biopharmaceutical production, covering manufacturing processes, industrial operations, and quality control strategies.

Course Details

• Course Code: BIOENGR X 431.2
• Duration: As few as 11 weeks
• Units: 4.0
• Current Formats: Online
• Cost: Starting at $1,100.00
• Typically Available: Winter, Summer

What You Can Learn

Understand key steps and industry best practices in biopharmaceutical manufacturing, from process development and scale-up to commercial production. Learn essential quality management principles, including Quality by Design (QbD), risk management, and regulatory compliance strategies. Develop critical thinking, problem-solving, and decision-making skills to tackle real-world manufacturing and quality control challenges. Gain industry-relevant insights into facility design, outsourcing, vendor management, and cost considerations for a well-rounded understanding of biotech production.

About This Course

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.

Summer 2026 Schedule

• Date: June 22 - September 6
• Instructor: Yuwei Wang
• Format: Online
• Fee: $1,100.00
• Notes: Enrollment limited; early enrollment advised. Enrollment deadline: June 28, 2026.
• Deadline: Refunds only available from April 27, 2026 to July 05, 2026

Course Requirements

• Book: Manufacturing of Pharmaceutical Proteins: From Technology to Economy by Dr. Stefan Behme
• Internet Access: Required to retrieve course materials

Applicable Programs

• Biotechnology Engineering Certificate: This course applies toward the Biotechnology Engineering certificate, which covers the fundamentals of biotech engineering, including design, manufacturing, quality, and regulatory requirements. Format: Online.