Industrial Production Biotech Products

Year
1
Academic year
2021-2022
Code
02556029
Subject Area
Pharmaceutical Sciences
Language of Instruction
Portuguese
Mode of Delivery
Face-to-face
Duration
SEMESTRIAL
ECTS Credits
5.0
Type
Compulsory
Level
2nd Cycle Studies - Mestrado

Recommended Prerequisites

Knowledge acquired in 1st cycle courses in the areas of basic studies in pharmaceutical sciences, medicinal chemistry, biochemistry, pharmaceutical biomedicine, bio-analytical sciences, biomedical sciences and other courses considered adequate by the coordination of the master course.

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
Synthesis work: 15.0%
Other: 20.0%
Exam: 30.0%
Research work: 35.0%

Bibliography

Glick, Bernard R., Jack J. Pasternak, and Cheryl L. Patten. Molecular Biotechnology: Principles and Applications of Recombinant DNA. Washington, DC: ASM Press, 2010.

Walsh, G, Biopharmaceuticals: Biochemistry and Biotechnology, John Wiley and Sons, New York, 2002.
Directiva 2003/63/CE da Comissão de 25 de Junho e Decreto-Lei n.º 97/2004. “D.R. I Série A” 96 (2004-04-23) 2510. Introdução de Medicamentos no Mercado.
Boas Práticas de Fabrico de medicamentos (Anexo-2 - Produção de produtos biológicos para uso humano).
Guideline 3AB1a – Production and quality control of medicinal products derived by recombinant DNA technology.
Guideline 3AB2a – Quality of biotechnological products: analysis of the expression construct in cells used for production of rDNA derived protein products.
Guideline 3AB5a – Quality of biotechnological products: stability testing of biotechnological/biological products.