In Principles of Biomanufacturing, the course covers several key concepts that are essential to understanding the field. These concepts include:
- The History of Modern Biomanufacturing: The course provides an overview of the historical development of biomanufacturing, tracing its origins and evolution over time. Understanding the historical context helps learners appreciate the advancements and significance of biomanufacturing in the modern world.
- Protein Structure and Function: This topic delves into the fundamental principles of protein structure and function. Learners explore the building blocks of proteins, their three-dimensional structure, and how this structure influences their function. Understanding protein structure is crucial for comprehending the production and engineering of biologic drugs.
- Cell Line Development: Learners gain insights into the process of engineering cells to produce target proteins. This involves selecting appropriate host cell lines, creating a master cell bank, and optimizing protein expression levels in cells. Cell line development is a critical step in biomanufacturing and plays a significant role in the production of biologic drugs.
- Cultivating Cells in a Bioreactor: This concept focuses on upstream processing, which involves culturing cells under controlled conditions to manufacture protein therapeutics. Learners explore scaling principles for large-scale production, the role of bioreactors in cell expansion, and strategies for optimizing production quantity and quality.
- Processing Raw Material into Drug Substance: The course covers downstream processing, which involves isolating and purifying the biologic protein from the cell culture. Learners follow the production process from the end of upstream processing through various steps of downstream processing, such as primary recovery, initial purification, polishing, and formulation.
- Regulation of Drug Production: This topic introduces learners to the regulatory restrictions and requirements that govern the biomanufacturing industry. It explores the importance of process control, validation, product testing, and ongoing verification to ensure regulatory compliance and the safety of biologic medicines.
By covering these key concepts, Principles of Biomanufacturing provides learners with a comprehensive understanding of the principles and processes involved in biomanufacturing. This knowledge equips them to navigate the complexities of the field and contribute effectively to the production of biopharmaceutical products.