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Apr 19, 2024
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Graduate School Course Catalog 2018-2019 [ARCHIVED CATALOG]
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PHRG 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 manufacturing in the pharmaceutical and biotechnology industries with an emphasis of 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 characterization, and QA/QC will be defined. The role of bioanalytical characterization will be detailed as it applies to the issues of drug stability, formulation and delivery. 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, and documentation and regulation of GMP facilities. The Regulatory processes including an overview of CBER, CDER and ICH guidelines will be included.
Click here for the Spring 2022 Class Schedule
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