Principles of Biomanufacturing: Using Biotechnology to Manufacture Medicines is a six-week self-paced online course for developing an integrated understanding of the modern processes for the creation of biopharmaceutical products.
Humans have leveraged the power of cells for millennia to produce staples such as bread, cheese, beer, and wine. Yet, we have only recently begun to utilize cells as factories for the production of pharmaceutical biologic drugs—protein therapeutics—like insulin. These life-saving medicines are able to treat otherwise untreatable diseases.
This course teaches fundamental concepts, methods, and processes behind how living cells are engineered to produce complex biologic drugs—focusing on protein therapeutics manufactured using recombinant DNA technology. It also explores the history of biotechnology to contextualize the place of the industry in the modern world. The course will connect the theoretical and engineering fundamentals of the industry to real-world applications by showing real biomanufacturing equipment in action and experts describing modern processes and the real-world engineering challenges they face.
This course is well suited for scientists and engineers, as well as manufacturing managers, process validation staff, and quality assurance professionals working in the biopharmaceutical industry in non-development capacities, as well as other technical professionals looking to better understand the industry or pursue careers in biotechnology.
In the first week, you will review the history of modern biopharmaceutical manufacturing, become familiar with the foundational concepts and terminology, and understand the role that biomanufacturing plays in the modern world.
In week two, you will expand on your understanding of the building blocks of biologics, focusing on protein structure, and identify the differences between biologics and traditional small molecule drugs. You will explore three functional categories of protein therapeutics: therapeutics with enzymatic or regulatory activity, with special targeting activity, and protein vaccines.
The third week of the course focuses on understanding cell line development. You will investigate the process of engineering cells to produce target proteins, from selecting an appropriate host cell line to creating a master cell bank. You will learn to identify key features of a protein expression vector and maximize protein expression levels in cells.
The fourth week of the course will focus on upstream processing—culturing cells under controlled conditions to manufacture a protein therapeutic. You will investigate scaling principles for large-scale production, and learn how bioreactors are at the center of the cell expansion process—providing sufficient capacity for and optimizing production quantity and quality.
The fifth week of this course focuses on the final step in production, downstream processing, which isolates and purifies the biologic protein. You will follow the production process from the end of upstream processing through four main steps of downstream processing—primary recovery, initial purification, polishing, and formulation—to arrive at the final product, a safe and efficacious biologic medicine.
The sixth and final week of this course drills down into one of the most important steps of downstream processing—using chromatography in the purification process. You’ll see real pieces of biomanufacturing equipment in action and hear experts explain and describe the real-world engineering challenges the equipment and processes solve.
The final week will also introduce and discuss the regulatory restrictions and requirements that work to ensure safety within the industry and for consumers. You will explore the process control, process validation, product testing, and ongoing process verification that biomanufacturers implement to ensure regulatory compliance and safety.
The course will provide a holistic view of the origins of modern biomanufacturing, a multidisciplinary overview of its foundational concepts and principles, an understanding of the realities of production, and an appreciation of the current state of the industry and its impact on the world.