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Development of New Vaccines
BT 4501 / 3 q.h.
June 25 - August 18
Boston 5:45 PM-8:45 PM
The nature of infection, parasitic organisms (bacterial and viral), pathology, and immune responses will be discussed in terms of host-parasite interactions. Emphasis will be placed on methods used for the identification of potential vaccine antigens. New techniques for vaccine design, expression, and delivery are examined. Classical and current strategies used to produce effective vaccines will be discussed. Emphasis will be placed upon acquiring a general understanding and application of the process of vaccine development.
Prerequisites: One year each of college-level biology and chemistry, or permission of instructor.
R&D Regulatory Affairs, Good Laboratory Practices and Clinical Trials
BT 4514 / 3 q.h.
June 25 - August 18
Boston 5:45 PM-8:45 PM
Designed for degree and nondegree candidates, this course presents the history and current interpretation of regulations involved in development of new biotechnology products. The course focuses on the issues critical to research and process development prior to licensure of biologic, drug, and device products by the FDA. Discussions include the transition from GLPs to cGMPs as a product moves through clinical trials and basic understanding of auditing clinical trials. |
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