PBB814 - Biotechnology and Biopharmaceuticals

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Last revision date Feb 12, 2019 2:31:25 PM
Last review date Mar 18, 2019 9:39:07 AM

Subject Title
Biotechnology and Biopharmaceuticals

Subject Description
This subject is an introduction to biopharmaceuticals and the application of biotechnology to produce them. Emphasis is on the regulations affecting the development and manufacturing of biopharmaceuticals and how they differ from traditional pharmaceuticals. Topics include: basic principles of biotechnology, large scale biopharmaceutical manufacturing, major differences in the regulatory process between biopharmaceuticals and traditional pharmaceuticals, combination biologics and medical device biologics. Students also explore future technologies employed in the biopharmaceutical and biotechnology industry to develop novel products.

Credit Status
This is a credit toward the Ontario College Graduate Certificate Program in Pharmaceutical Regulatory Affairs and Quality Operations offered through the School of Biological Sciences and Applied Chemistry and the Faculty of Continuing Education and Training.

Learning Outcomes
Upon successful completion of this subject the student will be able to:

  1. Discuss the principles of biotechnology and biopharmaceuticals.
  1. Describe the processes involved in the production of biopharmaceuticals.
  1. Apply Canadian regulatory guidelinesand International Conference on Harmonization (ICH) practices to the production of biopharmaceuticals.
  1. Compare the submission processes for biopharmaceuticals and traditional drugs.
  1. Prepare specific components in the Quality Overall Summary (QOS) of a New Drug submission of a biopharmaceutical.


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