Biotechnology has created more than 200 new therapies and production levels now routinely exceed metric tons for many antibodies. Product complexity has also increased as stem cell therapies have entered clinical studies and the first antilogous cellular therapies have recently been approved in the United States. In turn, ensuring product quality has grown in importance and complexity. Instances of product recalls and regulatory enforcement actions are frequent and result in supply shortages and significant loss of corporate reputation and value. Production of biotechnology products requires comprehensive quality standards and systems that meet global cGMP expectations and are based upon thorough scientific knowledge of the product and process.
Persons knowledgeable in the principles and practice of biopharmaceutical quality management are in high demand and hold positions of significant responsibility within the private and public sectors of the healthcare industry. The primary goal of this course is to provide students with an advanced background in the principles and requirements of biopharmaceutical quality assurance and control. Through a series of lectures and case studies this course will teach the critical thinking and judgment skills that are needed for the development of quality systems and the resolution of product quality issues.