Campus: PADOVA

Language: English

Teaching period: Second Semester


Number of ECTS credits allocated: 8

Prerequisites: Students are expected to have knowledge and competence of cellular and molecular biology and of biochemistry to be able to understand the fundamental aspects of mammalian large scale cell culture in upstream and downstream processes.
Examination methods: Final exam will be oral. Students will be evaluated collegially by both professors.
Course unit contents: Overview of the biopharmaceutical industry. Upstream and downstream processes. GMP/GLP regulatory requirements for processing biopharmaceuticals. Lab/pilot scale process to implement full manufacturing scale. Consistency and robustness in a fermentation process. Large scale mammalian cell culture. Cell line engineering techniques and common host cell lines used. Bioreactor operation mode: batch, fed batch, continuous and perfusion culture. Selection of bioreactor type (spinner flask, stirred tank). Attachment systems for cell cultivation in adhesion (plates, roller bottle, and stacked plate system) packed bed bioreactor, microcarriers, fluidized bed bioreactor, hollow fiber and wave bioreactor. Perfusion systems for cell cultivation (hollow fiber, spin filter, acoustic cell separation, alternating tangential flow (ATF) system). Design of cell culture medium without serum and with low content of proteins. Scaffold and matrix in bioreactors. How to calibrate oxygen, pH, nutrients and metabolites, cell density and viability in the bioreactor. Design of large scale cell culture process for mammalian cell culture. How to improve cell viability in a process. Expression of cloned proteins in mammalian cells, e.g. interferon and insulin. Large scale production of monoclonal antibodies and their use. Vaccine process development in mammalian cells and manufacturing of vaccins. Embryonic and adult stem cell cultures and their application in cell therapy. Biomolecules of pharmaceutical interest. Cytokines: interleukins and interferons. Hormons: insulin and growth hormone. Enzymes: tissue plasminogen activator and DNase. Erithropoietin. Heparin. Monoclonal antibodies: pharmaceutical and therapeutic properties. Monoclonal antibody-based drugs for antitumor, immunosuppressive, antithrombotic, antiviral, antiasthma and antiangiogenic therapies. Antisense oligonucleotides: approved agent and clinical trials. Aptamers. Ribozymes.