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Unit of study_

CHNG5605: Bio-Products: Laboratory to Marketplace

The objectives of the course are to provide students with an overview of biochemical and pharmaceutical industry. It will give students an insight into drug delivery systems and formulation; how therapeutic drugs work; and a general overview of biochemical and pharmaceutical marketing. The design and management of clinical trials, which are key factors for development of any new therapeutic agent will also be covered in the course. The challenges for commercialisation of innovative methods and/or biochemical and pharmaceutical products and aspects of intellectual property protection will be elaborated. Ultimately the aspects of Good Manufacturing Practice (GMP) and international legislation for marketing pharmaceutical products will be illuminated. Lectures in this course will be delivered by both University of Sydney staff and by a number of visiting professional representatives from industry and government agencies. We will also arrange a site visit for a bio-manufacturing company as warranted. When you successfully complete this course you acquire knowledge about drug formulation, pharmaceutical processing including physical processes, legislation governing the bio-manufacturing and commercialisation of biochemicals and pharmaceuticals. The information would be beneficial for your future career in pharmaceutical manufacturing companies. Students are encouraged to engage in an interactive environment for exchange of information. This course will be assessed by quizzes, assignments, oral presentation and final report. This unit of study is offered as an advanced elective unit of study to final year undergraduate students. Students may be required to attend lectures off-campus.

Code CHNG5605
Academic unit Chemical and Biomolecular Engineering
Credit points 6

At the completion of this unit, you should be able to:

  • LO1. utilise team-working skills to review, analyse, and consolidate knowledge in a technical report about the manufacturing of a biomedical product
  • LO2. document compliance with good-manufacturing guidelines for food, pharmaceuticals and biomedical products.
  • LO3. write an in-depth technical report
  • LO4. undertake an evaluation of the potential market for new biomedical products
  • LO5. explain key terms, principles and issues of food, pharmaceutical and biomedical manufacturing, including physical processes, GMP related issues, aspects of marketing and clinical trials
  • LO6. analyse production requirements and determine appropriate manufacturing process stages for a given food or biomedical product.