Principles of Biomanufacturing: Using Biotechnology to Manufacture Medicines is a six-week self-paced online course that provides an integrated understanding of the modern processes involved in creating biopharmaceutical products.
This course is designed for individuals who are interested in biomanufacturing and biotechnology, particularly those working in the biopharmaceutical industry or seeking to pursue careers in biotechnology. It is suitable for scientists, engineers, manufacturing managers, process validation staff, quality assurance professionals, and other technical professionals who want to deepen their understanding of the industry.
Throughout the six weeks of the course, participants will cover various topics:
- Week 1: Introduction to the history of modern biopharmaceutical manufacturing and the role of biomanufacturing in the present world.
- Week 2: Exploring the building blocks of biologics, with a focus on protein structure and the differences between biologics and traditional small molecule drugs. Three functional categories of protein therapeutics are discussed.
- Week 3: Understanding cell line development, including the process of engineering cells to produce target proteins, selecting a suitable host cell line, and creating a master cell bank.
- Week 4: Focuses on upstream processing, which involves culturing cells under controlled conditions for protein production. Scaling principles and bioreactors' role in cell expansion and optimization are covered.
- Week 5: Covers downstream processing, the final step in production that isolates and purifies the biologic protein. Participants learn about primary recovery, initial purification, polishing, formulation, and arriving at the final product.
- Week 6: Drills down into the use of chromatography in the purification process. Participants observe real biomanufacturing equipment in action and gain insight into the engineering challenges involved. Regulatory restrictions, process control, validation, testing, and ongoing process verification are also discussed.
By the end of the course, participants will have gained a holistic view of modern biomanufacturing, including its origins, foundational concepts, and principles. They will also develop an understanding of the production realities and the current state of the biopharmaceutical industry.
The course is self-paced, allowing learners to progress through the content at their own speed. It provides a comprehensive overview of biomanufacturing processes and their impact on the world of medicine.