Technologies for Biopharmaceutical Development

Technologies for Biopharmaceutical Development

Coordinator
Paula Marques Alves

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.
- Final formulation: stability and adjuvants
- 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 research papers in the tutorial sessions. Papers will be chosen by the students from a list timely supplied by the Curricular Unit coordinator.

Main Bibliography

• “Culture of Animal Cells: A Manual of Basic Technique and Specialized Applications (6th Edition)”, R. Ian Freshney (Ed), Wiley-Blackwell (Pub), 2010
• Animal Cell Technology: From Biopharmaceuticals to Gene Therapy, Castilho, Morais, Augusto e Butler (Ed), Taylor and Francis Group (Pub), 2007
• Recent research and review papers published in high impact peer-review journals such as Nature Biotechnology, Trends in Biotechnology, Biotechnology and Bioengineering, Journal of Biotechnology.