Course info

THIS COURSE WILL GIVE AN INSIGHT INTO THE EVER-INCREASING LISTS OF PRESCRIBED
BIOTECHNOLOGY DRUG PRODUCTS (BIOLOGICS) SUCH AS PROTEIN, NUCLEIC ACID-BASED THERAPIES
(VIRAL VECTORS FOR GENE THERAPY) AND IMMUNO-THERAPEUTICS (MONOCLONAL ANTIBODIES,
VIRUS-LIKE PARTICLE VACCINE CANDIDATES). THE APPLICATION OF RECOMBINANT DNA
TECHNOLOGY AND GENETIC ENGINEERING/MANIPULATION FOR THE GENERATION OF
BIOPHARMACEUTICALS OR PROTEIN DRUGS/ANALOGS WITH THE DESIRED/ENHANCED THERAPEUTIC
PROPERTIES WILL BE HIGHLIGHTED IN THIS COURSE. UPSTREAMING (VECTOR CONSTRUCT DESIGN &
HOST CELL SELECTION) AND DOWN STREAMING (PURIFICATION, FORMULATION, DISPENSING)
PROCESSES IN BIOPHARMACEUTICAL PRODUCTION WILL ALSO BE DISCUSSED. TOPICS RELATED TO
GOOD MANUFACTURING PRACTICES (QUALITY ASSURANCE, PROCESS VALIDATION) FOR
BIOTECHNOLOGY-BASED PRODUCTS WILL ALSO BE TAUGHT. STUDENTS WILL ALSO BE GIVEN EXPOSURE
REGARDING REGULATORY GUIDELINES CONCERNING BIOLOGICS/BIOPHARMACEUTICAL DRUG APPROVAL
AND THE VARIOUS ETHICAL, LEGAL AND SOCIAL ISSUES ASSOCIATED WITH BIOTECHNOLOGY-BASED
PRODUCTS.