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Apr 30, 2024
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Graduate School Course Catalog 2017-2018 [ARCHIVED CATALOG]
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PHRM 5110 - Biopharmaceutical Manufacturing (3)
Prerequisites: Biochemistry, Genetics, Bioanalytical Chemistry, Bioprocessing and Cell culture or with the consent of the instructor. This graduate level course provides an extensive overview of the process of drug manufacture in the pharmaceutical and biotechnology industries with an emphasis on the production of biopharmaceuticals. This course is designed for individuals entering the biotechnology, medical device, pharmaceutical development, and vaccine industries. An understanding of the scientific, technical and regulatory aspects of developing safe and efficacious therapeutics will be detailed. The lecture series will cover drug production with an emphasis on microbial and mammalian systems. The roles of different departments such as process development, bioanalytical, QA/QC will be defined. The role of bioanalytical characterization as it applies to the issues of drug stability, formulation and delivery will be detailed. The lecture series will emphasize the requirements and application of good manufacturing practices (cGMP), with detailed reviews of process development procedures, standard operating procedures (SOPs), procedures for validation of equipment and computer systems, documentation and regulation of GMP facilities. The Regulatory process including an overview of CBER, CDER and ICH guidelines will be included.
Click here for the Spring 2022 Class Schedule
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