2024
Biotechnological Medicines
Name: Biotechnological Medicines
Code: CMS11481L
6 ECTS
Duration: 15 weeks/156 hours
Scientific Area:
Biological Sciences
Teaching languages: Portuguese
Languages of tutoring support: Portuguese, English
Regime de Frequência: Presencial
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.Molecular Biotechnology and Medicine;
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
Practical:
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. 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 the new medicine
1. Introduction.Molecular Biotechnology and Medicine;
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
Practical:
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. 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 the new medicine
Teaching Methods
The theoretical classes will focus on the theoretical exposition of the programmatic subjects.
Theoretical-practical classes will be focused on the application of the knowledge acquired in the theoretical component and based on problem solving, analysis of practical cases and the presentation and discussion of scientific articles and/or work developed within the classroom.
Theoretical-practical classes will be focused on the application of the knowledge acquired in the theoretical component and based on problem solving, analysis of practical cases and the presentation and discussion of scientific articles and/or work developed within the classroom.
Assessment
The assessment of the curricular unit might be carried out continuously or through a final exam. Continuous assessment will include:
- 2 tests (60%)
- Work developed during theoretical-practical classes (30%)
- Attendance at theoretical and theoretical-practical classes (10%)
- 2 tests (60%)
- Work developed during theoretical-practical classes (30%)
- Attendance at theoretical and theoretical-practical classes (10%)
Teaching Staff
- Cátia Moreira de Sousa [responsible]
Certificações
