Industrial Production of Biotechnological Products

Recommended Prerequisites

All areas of life sciences (examples: Pharmaceutical Sciences, Medicine, Biochemistry or Biology).

Teaching Methods

Exposing lectures. Discussion of case studies. Problems solving.

Learning Outcomes

Provide knowledge on development and industrial production of recombinant products within the correspondent regulatory scope. Characterization of biological agents of production and correspondent products. Patents in biotechnology and the biopharmaceutical market.
Perform relevant tasks on:
- development, production and control of biotechnological-based medicines.
- regulatory affairs on advanced technology-based medicines.
- storage, dispensing and use of biologics medicines in clinical practice and implementation of novel therapeutic strategies as well.

Work Placement(s)

No

Syllabus

Production of recombinant proteins with pharmacological interest;
Procariotic and eucariotic systems of heterologous expression.
Protein engineering; targeted and combinatorial mutagenesis.
Large scale production of recombinant proteins.
Good manufactirung practices; facilities, production processes andquality control.
Prepastion of raw materials. Importance of cell banks.
Bioprocessing; types of bioreactors
Bioseparation; concentration and purification;
Formulation, packaging anfd control.
Regulatory affairs of biotechnological-based products.

Marketing authorization; centralized procedure.
Guidelines for development, production, control and stability assessment of recombinant DNA-derived products
Patents in Biotechnology

Head Lecturer(s)

Sérgio Paulo Magalhães Simões

Assessment Methods

Assessment
Clipping presentation: 20.0%
Paper presentation: 40.0%
Exam: 40.0%

Bibliography

Glick BR and Pasternak JJ, Molecular Biotechnology, Principles and Applications of Recombinant DNA (3rd edition), ASM Press, Washington, 2003.
Sambrook J and Russel DW, Molecular cloning, A laboratory manual (3rd edition) Cold Spring Harbor
Laboratory Press, New York, 2001.
Walsh, G, Biopharmaceuticals: Biochemistry and Biotechnology, John Wiley and Sons, New York, 2002.
Videira, A, Engenharia genética. Princípios e Aplicações, Lidel, Lisboa, 2001.