2024
Biotechnological Medicines and Therapeutics
Name: Biotechnological Medicines and Therapeutics
Code: CMS13780I
6 ECTS
Duration: 15 weeks/156 hours
Scientific Area:
Ciências Farmacêuticas
Teaching languages: Portuguese
Languages of tutoring support: Portuguese
Presentation
This UC presents the opportunities and the necessary concepts for therapeutic intervention in man arising from current knowledge in the scientific areas of Molecular Biology, Biotechnology and the functioning of target systems and the human immune system.
Sustainable Development Goals
Learning Goals
1. Understanding the opportunities for therapeutic actions in Man from recent knowledge on Molecular Biology and Biotechnology on the functioning of human systems, namely the immune system.
2. Understanding of techniques on Genetic Engineering to be used on the development of human therapies based on biotechnological medicines and gene therapy.
3. Apprehension of relevant concepts on safety for the industrial scale production of biotechnological medicinal products
4. Apprehension of relevant concepts on Pharmacogenomics for the effectiveness of medicinal products.
5. Adoption of technical specification for the characterization of medicinal products of biotechnological origin and its relevance for the official requirements on Quality, Safety and Efficacy.
6. Critical analysis on case studies of new biotechnological medicinal products.
2. Understanding of techniques on Genetic Engineering to be used on the development of human therapies based on biotechnological medicines and gene therapy.
3. Apprehension of relevant concepts on safety for the industrial scale production of biotechnological medicinal products
4. Apprehension of relevant concepts on Pharmacogenomics for the effectiveness of medicinal products.
5. Adoption of technical specification for the characterization of medicinal products of biotechnological origin and its relevance for the official requirements on Quality, Safety and Efficacy.
6. Critical analysis on case studies of new biotechnological medicinal products.
Contents
Theoretical
1. Introduction
2. Monoclonal antibodies as medicinal products
3. New medicinal products from recombinant DNA
4. Preparation of medicinal products using biotechnology techniques
5. Quality, Safety and Efficacy of biotechnological and monoclonal antibody products
6. Biosimilar Medicines
7. Regulamentar issues on biotechnological medicinal products and monoclonal antibodies
Practice
1. Culture of host bacteria and competent cells
2. Competent cell transformation with expression plasmids
3. Selection of recombinants by restriction analysis
4. Selection of recombinants by expressed products
5. Characterization of the recombinant cell
6. Optimization of cell expression
7. Preparation of the Cell Bank
8. Purification and characterization of the recombinant product
9. Critical reports on the laboratorial experimentation
Inventive program
1. Identification of a new molecular entity for therapeutic uses
2. Discussion of the working plan for the production of a new medicine
1. Introduction
2. Monoclonal antibodies as medicinal products
3. New medicinal products from recombinant DNA
4. Preparation of medicinal products using biotechnology techniques
5. Quality, Safety and Efficacy of biotechnological and monoclonal antibody products
6. Biosimilar Medicines
7. Regulamentar issues on biotechnological medicinal products and monoclonal antibodies
Practice
1. Culture of host bacteria and competent cells
2. Competent cell transformation with expression plasmids
3. Selection of recombinants by restriction analysis
4. Selection of recombinants by expressed products
5. Characterization of the recombinant cell
6. Optimization of cell expression
7. Preparation of the Cell Bank
8. Purification and characterization of the recombinant product
9. Critical reports on the laboratorial experimentation
Inventive program
1. Identification of a new molecular entity for therapeutic uses
2. Discussion of the working plan for the production of a new medicine
Teaching Methods
1. Theoretical presentations
2. Bench working according with predefined technical protocols
3. Oriented free laboratory work
4. Monograph presentations as public posters.
2. Bench working according with predefined technical protocols
3. Oriented free laboratory work
4. Monograph presentations as public posters.
Assessment
The evaluation of the theoretical component, by continuous assessment of frequencies or final examination, will have a relative weight of 70%.
The practical component will be evaluated by the report of one of the works carried out and will have a relative weight of 15%.
The evaluation of the monograph and its public presentation will have a relative weight of 15%.
If and when it is possible to do all face-to-face teaching, the relative weight of the monograph and the practical component will be reduced to 10% and 10% will be attributed to attendance to all teaching components.
The practical component will be evaluated by the report of one of the works carried out and will have a relative weight of 15%.
The evaluation of the monograph and its public presentation will have a relative weight of 15%.
If and when it is possible to do all face-to-face teaching, the relative weight of the monograph and the practical component will be reduced to 10% and 10% will be attributed to attendance to all teaching components.
Teaching Staff (2023/2024 )
- Pedro Miguel Amores da Silva [responsible]
Certificações
