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Upon completion of this course, the student will be able to:
1) Elucidate scientific principles for biotechnology in pharmaceutical product development.
2) Explain the components of, and challenges in development of biologicals and drugs in the pharmaceutical and biotechnology industry.
3) Apply advanced biotechnology in novel drug development
4) Describe approved biotech products, e.g., indications, advantages, disease impact, & product limits, & status of pipeline products, e.g., development issues.
5) Describe organization & processes in biotechnology and pharmaceutical industry for their operations and research and development, plus EMA oversight roles.
6) Describe the product launch of new products and their usage challenges, e.g., impact in health care systems, translation of product’s attributes to marketing and clinical usage, pharmaceutical marketing.
Traditional biopharmaceuticals obtained by molecular engineering; Strategies
Of biopharmaceutical discovery using molecular methods like proteomics, genomics
and metabolomics; strategies of developing biopharmaceuticals using biomolecular technologies of bacterial and mammalian manipulation; methods of discovering and developing therapeutic proteins by direct evolution; direct mutagenesis aiming to improve interaction and stability of therapeutic proteins; development strategies of therapeutic antibodies; Patent procedures and international protection; strategies of biopharmaceutical production using microbiological processes and mammalian cell culture; quality control of biopharmaceuticals.
Case studies will be covered in several aspects of biopharmaceutical R&D: Interferons, Interleukins and Tumor Necrosis Factor; Growth Factors; Hormones with therapeutic interest; Monoclonal and recombinant antibodies; Vaccines; Gene therapy and siRNA.