Hands-on Introduction to Biomanufacturing Operations

Want to gain a fundamental understanding of up- and downstream operations that comprise a typical biopharmaceutical process? The objective of this course is to introduce bioprocess and biomanufacturing concepts for employees. The focus will be on the production process for biomanufacturing. Both microbial-based processes (fermentation) as well as mammalian cell-based (cell-culture) will be discussed, and the differences emphasized. A key element of the course is to give practical fermentation experience in the pilot facilities at DTU. Course participants will be given guidelines but allowed freedom to operate (hands-on) fermentation at 50 L scale. In the pilot, for simplicity GFP (green fluorescent protein) expressed in E. coli will be used. The practical part includes the upstream part as well as the cell harvest by centrifugation. Relevant downstream unit operations for product capture and purification will be covered in lectures.

Participants do not need to have specific knowledge in the field of biotechnology other than a basic high-school level understanding of natural sciences. At the end of this course, participants will be able to: • Understand the basis for biomanufacturing processes (upstream and downstream) • Understand the biomanufacturing process environment (pilot plant) • Understand the challenges that can arise during biomanufacturing • Understand the importance of monitoring processes and collecting process data (towards cGMP) • Understand the vocabulary used in biomanufacturing

Nongraded

The course is broadly applicable to anyone who is interested in learning about large-scale biomanufacturing operations and gaining hands-on experience in a simulated cGMP environment. This course is perfect for new employees, support personnel from Quality Control and Quality Assurance, and vendors and suppliers who provide equipment and services to the industry. This course is for individuals with background, skills, and/or experience in the following areas: New employees in biomanufacturing, including scientists, engineers and operators, Support personnel who are directly or indirectly involved with the manufacturing process, Suppliers and vendors of technical equipment used in biomanufactoring, Workers who are entering the biomanufactoring industry. Hands-on Microscopy (Tailor-Made Course). Prerequisites: Participants do not need to have specific knowledge in the field of biotechnology other than a basic high-school level understanding of natural sciences