Pharmaceutical biotechnology

Students will know the applications of Biotechnology in the Health area, with special emphasis on the application of genetic engineering techniques in the development of new pharmaceutical products. The fundamentals of these processes and their present and future possibilities will be analysed.

The fundamental content of this discipline is the part of biotechnology known as Red Biotechnology, and refers to the biotechnological applications for the human and animal health, which include different technologies. The subject is divided in three parts:
In the first part, there will be a very brief review about biotechnology and its application to obtain drugs.
In the second part we will assess the study of genetic engineering techniques from a basic and advanced point of view and the use of those techniques to produce drugs. Nowadays genetic engineering is essential for pharmaceutical industry since it improves the yield of the classical fermentation processes such as production of antibiotics, vitamins, steroids, etc. and it allows the cutting-edge development of drugs. Thus, hormones, vaccines, antibodies, interferons are produced by fermentation. In this part we will focus on molecular cloning and its biotechnological application to obtain biotechnological products or to perform genetic edition and other applications.
In the third part, we will address the biotechnology applied to the plants, accomplishing the production and characterization of transgenic plants and their multiple applications in improving the yield and quality of species of socio-economic interest and the use of plants as biofactories to obtain products with nutritional and sanitary interest.

Theory program:

CHAPTER 1. Introduction to Biotechnology. Historical development. Classification. Biotechnology in the Pharmaceutical Industry.
CHAPTER 2. Industrial microbiology. Technology and industrial processes. Microbial biomass. Bioconversions. Primary metabolites. Secondary metabolites. Examples of interest in Biotechnology.
CHAPTER 3. Recombinant DNA technology. Basic and advanced techniques in Genetic Engineering. Historical development of recombinant DNA technology. Impact on the biotech industry and milestones.
CHAPTER 4. Protein engineering.
CHAPTER 5. Recombinant antibodies.
CHAPTER 6. Recombinant vaccines.
CHAPTER 7. Gene editing. Genetic recombination. CRISPR-Cas and its application in gene editing. Transgenic animals. Knock-out mice. Xenotransplantation. Transgenic drugs. Gene therapy. Cell therapy. Use of adult and embryonic stem cells. Plant biotechnology in the pharmaceutical industry. Transformation of plants. Plants as bioreactors.

Laboratory program:
Genetic engineering. Process design. Basic techniques. Molecular cloning and expression of genes in bacteria using recombinant DNA technology.
Analysis of gene expression in plants using Real-time PCR.

Basic bibliography:
Clark, D. P. & Pazdernik, N. J. (2016) Biotechnology. Second edition. London: Academic Cell. Available on-line.
Brieva, H. M. (2018) Fundamentos de biotecnología farmacéutica. Madrid: Dextra Editorial. Available on-line.
Howard, J. A. & Hood, E. E. (2014) Commercial plant-produced recombinant protein products : case studies. Berlin: Springer.
Jiang, L. & Kermode, A. R. (eds.) (2018) Molecular pharming: applications, challenges, and emerging areas. New Jersey: Wiley Blackwell. Available on-line.
Thieman, W. J. & Palladino, M. A. (2010) Introducción a la biotecnología. Segunda edición. Madrid: Pearson Educación. Available on-line.

Complementary bibliography:
Glick, B.R., Pasternak, J.J., Cheryl, L. (2010) Molecular biotechnology: principles and applications of recombinant DNA. 4th ed. Washington, DC: ASM Press. Available on-line.
Srivastava, S. & Narula, A. (2005) Plant Biotechnology and Molecular Markers. 1st edition. Dordrecht: Springer Netherlands. Available on-line.

Online resources:
The virtual classroom will include materials prepared by teachers and links to online resources.

Knowledge:
Con 01. Know the origin, nature, and how to design, obtain, analyze, control and produce active ingredients, drugs and medicines, as well as other products and raw materials of health interest for human or veterinary use.
Con 19. Understand the structures of biomolecules and their transformations in the cell.
Con 29. Know the basic operations and technological processes related to the manufacture and control of medicines

Skills or abilities:
H/A 15. Develop skills to identify therapeutic targets and biotechnological production of drugs, as well as the use of gene therapy.

Competences
Instrumental competences:
Comp 03. Oral and written communication in one's own language.
Comp 05. Basic computer skills. Comp 06. Information management skills (ability to search for and analyze information from miscellaneous sources).
Comp 07. Problem solving.

Systemic competences:
Comp 11. Teamwork.
Comp 18. Ability to apply knowledge in practice.
Comp 22. Ability to generate new ideas (creativity).
Comp 26. Design and project management.

To support teaching, a virtual classroom will be available on the Moodle platform of the Virtual Campus, to which teaching material will be uploaded and which will be used as a means of communication with students.
1. Lectures. Synchronous face-to-face teaching in the classroom. Theory lectures given by the teaching staff supported by modern audiovisual techniques, combined with oral presentations by the students.
2. Seminars. Synchronous face-to-face teaching in the classroom. Throughout the course, questions and problems that students must answer individually or as a team will be provided, and they will be delivered through the virtual classroom to be corrected by the teachers. Debates and games (gamification) will be held to encourage learning of certain aspects of the subject.
3. Laboratory Practices.
Microbiology area: Compulsory in which each student must prepare their own work material and must carry out the proposed experimental assays individually. Students will have a script on the Virtual Campus in which they will find all the information to complete the practices successfully. On the last day of practices, a questionnaire will be carried out, the grade obtained will be included in the final evaluation.
Plant Physiology Area: compulsory in which each student must carry out the experimental part and interpret the results individually. They will be carried out in person in the laboratory and evaluated through questions formulated at the end of the practice sessions.
4. Tutorships: Face-to-face in the classroom.

The final mark for each block (Microbiolgy and Plant Physiology) will be weighted as follows:
a) Final exam (program contents): 65%
b) Seminars: Presentations, newsletters, questionnaires, etc.: 15%
c) Practices: 20%. Mandatory. Evaluation with questions at the end of the practices and / or with questions in the final exam.

It will be necessary that the grade of the theoretical exams is equal to or greater than 4 out of 10 in order to be able to add the rest of the merits to the continuous evaluation.
The student's final grade will be the sum of the weighted grades obtained for the continuous assessment (b + c) and for the final exam in each area. On the final grade, the Microbiology block constitutes 2/3 and the Plant Physiology 1/3. To pass the course it will be necessary to obtain a minimum of five points (without weighting) in each of the blocks.
In the 2nd evaluation opportunity of the academic year, only the theory exam will be carried out, keeping the grade corresponding to the continuous evaluation (b + c). In case of having approved only one block in the first opportunity, this qualification will be maintained exclusively in the second opportunity.
The practice mark will be kept in the two subsequent academic years in case of failing the subject.

The evaluation of the knowledge, skills and competencies acquired in the course will be done through the following channels:
1. On the exam: Con 01, Con 29, Con 19, Comp 07, Comp 18.
2. In laboratory practices: Comp 07, Comp 18.
3. In interactive classes: H/05, Con 01, Con 29, Comp 07, Comp 18.


For cases of fraudulent performance of exercises or tests, the provisions of the "Regulations for evaluating students' academic performance and reviewing grades " will apply.

In-class hours:
Lectures: 23
Seminars: 7
Laboratory: 11
Tutorials, exams: 3.5

Student personnel work hours:
Studio: 40
Laboratory: 2
Seminars, works: 25
Total: 112.5 hours.

Attendance to class and continuous monitoring of the subject, both in the case of face-to-face and remote teaching.
Active participation in seminars.