This course will provide students with critical concepts to consider when implementing a single use system (SUS) strategy in a pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized small molecules and for bioprocesses that produce large-molecule biopharmaceutical products.
The course will discuss single use systems that are in either direct or indirect contact with the raw materials, intermediates, intermediate products, pharmaceutical drug substances or drug products.
Determining the optimal manufacturing strategy involves concepts from many disciplines. An effective evaluation will have a balanced viewpoint, with consideration from engineering, regulatory, quality project management and accounting. Balancing risks and rewards of a single use system (SUS) over a Multiple Use System (MUS) will help determine the most appropriate manufacturing strategy.