This capstone course in biotechnology considers the theoretical and practical aspects of implementing biotechnology, paying particular attention to current issues including: (1) technology transfer and commercialization; (2) patent protection in biotechnology; (3) Good Laboratory Practices (GLP); (4) Good Manufacturing Practices (Food and Drug Regulations, 2002 edition); (5) Good Clinical Practices (GCP); (6) Research Ethics Board guidelines; (7) validation studies; (8) downstream processing and the recovery of purified products; (9) novel developments in methodology. The course includes a seminar series by industry and regulatory experts and site visits to local biotechnology companies to assess how they have implemented and overcome obstacles to production and quality control.