This is a Related Course of the MOT program.
The course will present the process of taking a discovered biological activity through steps leading to a pharmaceutical product fit for marketing to the public. Students will gain an understanding of product development in a biotechnology company.We will examine the following topics:
How pharmaceutical companies acquire new potential products as well as the constraints and steps of the technical development
The choice of the producing system, type of organism and fermentation, transgenic animals and plants
Selection of the purification procedure, drug formulation and delivery and viral safety.
The integration within the overall development process of quality assurance, preclinical and clinical studies, patents as related to biological drugs as well as the principal elements of these components.
The course focuses on pharmaceuticals produced by biotechnology and from human blood plasma.
Case histories related to therapeutic monoclonal antibodies, recombinant proteins,
gene therapy and plasma fractions will be discussed. Examples of successful
and failed products and the reasons for these will be presented and analyzed.
There will be four guest speakers on the subjects of patents, regulatory affairs and quality assurance, and gene therapy, all experts in their respective fields.
Course
Website
Course
Syllabus (pdf)
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