 |
|
Technologies for Biopharmaceutical Development
Coordinator
Paula Marques Alves
Other lecturers
Industrial and Academic experts will be invited to give seminars on selected topics
Objectives
This curricular unit will provide the students specific know-how, skill and competence in technologies and processes specifically pertaining to biopharmaceutical development.
The main objective is to provide the student an overview on biopharmaceutics with a focus on recombinant bio-therapeutics and vaccines. Specific objectives are to gain knowledge on: 1) expression platforms available for complex biopharmaceutics production, with special emphasis on Animal Cell Technology and cell line development; 2) Innovative cell culture systems and purification tools; 3) Characterization tools for biopharmaceuticals; 4) Commercial exploitation of the areas of animal technology and its contextualization in the biotechnology market.
Syllabus
- Biopharmaceutical products: focus on recombinant proteins (eg monoclonal antibodies), Virus-like particles (VLPS’s), nucleic acids and viral vectors
- Expression platforms (bacteria, yeast, plant, animal)
- Principles of animal cell culture: primary cultures and immortalized cell lines; cell culture strategies (adherent vs. suspension).
- Methods for cell line development (random vs. targeted gene integration).
- Cell biology and physiology considerations for process development; medium design for cell culture.
- Advanced tools for upstream and downstream process development: bioreactor configurations, membrane technology, and single use platforms.
- Introduction to Good Manufacturing Practices (GMP).
- Characterization tools for biopharmaceuticals: quality control, bioactivity assessment.
- Commercial exploitation of animal cell technology and its contextualization on the biotechnology market; future markets: needs of the developing world.
Evaluation
Evaluation will be based on the presentation and discussion of a topic selected by the Curricular Unit coordinator.
Main Bibliography
-
Gene and Cell Therapy: Therapeutic Mechanisms and Strategies, Fourth Edition, Nancy Smyth Templeton, CRC Press, 2015.
-
Cancer Vaccines, Methods and Protocols, Methods in Molecular Biology, Editors: Lawman, Michael J.P., Lawman, Patricia D. (Eds.), Springer Protocols, 2014
-
Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, 2nd Edition Edited by Rodney J. Y. Ho and Milo Gibaldi. Wiley-Blackwell, 2013.
|
