Pharmaceutical biotechnology

- List the regulation and formulation of biotechnological drugs.
- Identify the main biotechnological drugs, their production processes and applications.
- Understand recent advances in innovative drugs and therapies and design strategies for the production of biotechnological drugs.

1. Theory classes program (20 h)

Topic 1 (1h) - Regulatory framework of biotechnological drugs.

Topic 2 (1h) - Authorization of medicines.

Topic 3 (1h) - Development of biological drugs in host cells.

Unit 4 (2h) - Manufacturing methods of biotechnological drugs.

Topic 5 (3h) - Routes of administration of biotechnological drugs.

Unit 6 (2h) - Main groups of biotechnological drugs.

Unit 7 (2h) - Advanced therapies.

Unit 8 (2 h) - Pre-formulation and stability of biotechnological drugs.

Topic 9 (1,5h) - Biotechnological drugs in parenteral forms I.

Topic 10 (1,5h) - Biotechnological drugs in parenteral forms II.

Topic 11 (2 h) - Transmucosal administration of biotechnological products.

Topic 12 (1 h) - Biomaterials in regeneration.


2. Program of interactive classes (12 h)

Seminar 1. Quality in the pharmaceutical industry (2h).

Seminar 2. Efficiency of biotechnological drugs in the current therapeutic framework (2h).

Seminar 3. Clinical trials of biotechnological drugs (2h).

Seminar 4. Introduction of biotechnology in the development of personalized medicine (2h).

Seminar 5. Formulation of biotechnological products (2h).

Seminar 6. Student's presentations - Biotechnological drugs (2h).


3. Program of laboratory classes (5h)
Practice 1 is carried out in the laboratory. Practice 2 is carried out in the computer room.

Practice 1. Experimental simulation of plasmatic levels after IV bolus drug administration (2.5h).
Practice 2. Pharmacokinetic modelling (2.5h).

4. Tutorials
Group tutorials to clarify doubts, provide information or guide progress in the acquisition of skills.It will be scheduled under demand and can be performed by MS Teams.

5. Exam and review
- Exam will be perfomed at the date asigned by the dean of the faculty (2h).
- Exam and provisional qualifications review will be taken in two sessions, in alternative dates (1,5h).

Basic
-Crommelin DJA, Sindelar RD, Meibohm B, editors. Pharmaceutical Biotechnology. Cham: Springer; 2019. ISBN: 978-3-030-00709-6. Location: A FA 114 A.
- Aulton M.E. and Taylor K.M.G. Aulton's pharmaceutics: the design and manufacture of medicines 6th. Ed, Elsevier, 2021. ISBN: 9780702081545. Location: A FA 20 E.
- M. E. Aulton. Pharmacy: the science of the design of pharmaceutical forms (2nd ed) Madrid. Elsevier, D.L. 2003. ISBN: 84-8174-728-9. Locations: A FA 20 B, A FA 20 C and A FA 20 D.
- Martín Brieva, Humberto. Fundamentals of pharmaceutical biotechnology. Madrid. Dextra. 2018. ISBN 9788416898510. Locations: A BT 17 and BT 149, also available online.
- Ratledge C and Kristiansen B, editors. Basic Biotechnology (3rd ed). Cambridge. Cambridge University Press. 2007. ISBN: 978-0-521-54958-5. Location: A BT 9.

Complementary
-Rowe, R. C. & Sheskey, P. J. (2012) Handbook of pharmaceutical excipients. 7th ed / edited by Raymond C. Rowe, Paul J. Sheskey. [et al.]. London: Pharmaceutical Press. Location: FA 730 C.
-Anon (2011) Real Farmacopea Española. 4a ed. Madrid: Ministerio de Sanidad y Consumo. Online availability.

Knowledge: Con01, Con03, Con04, Con05, Con06, Con07.
Abilities/skills: H/D01, H/D02, H/D03, H/D04, H/D05, H/D06, H/D07, H/D08, H/D10, H/D11, H/D12, H/D13, H/D14.
Competencies: Comp01, Comp02, Comp03, Comp04, Comp05, Comp06, Comp07, Comp08.

A) Lectures: master classes.
B) Interactive classes: collaborative learning, problem-based learning (ABP), case studies, e-learning.
C) Tutorials: resolution of doubts. This activity can take place virtually by MS Teams.
D) Practices: The practical classes are divided into two 2.5-hour modules and will be carried out in the computer room and laboratory.

None of these activities is mandatory, however, B and D items have scoreable activities for continuous assessment.

EVALUATION ELEMENTS:
A. Written exam: it will consist of between 4 and 6 short questions or problems, and a test module of up to 20 questions. To pass the exam it is necessary to obtain at least 45% of the maximum mark.
B. Seminars and ABP: the grade corresponds to the average of the exercises performed, assignments and participation in the seminar classes (40% of the grade for this element) and the assessment of the work and presentation of the ABP (60% of the grade). For this assessment, it is necessary to participate in the work and be present for its presentation in Seminar 6 (except absence for justified reasons).
C. Practices: attendance at the practices is mandatory if students want to be evaluated for them. Participation is assessed through attendance and the submission of a short report at the end of the practices.

The final mark (NF) out of 10 is obtained from the following formula: NF= 0,7*A+0,2*B+0,1*C.

To pass the subject, it is necessary to obtain an NF equal to or higher than 5. For the second chance evaluation, grades B and C (continuous evaluation) are retained. If requested by the students, grades B and C may be withheld if the subject was taken in previous academic years.

Assessment of learning outcomes:
- Exam: Con01, Con03, Con04, Con05, Con06, Con07. H/D01, H/D11, H/D14. Comp01, Comp02, Comp03, Comp04, Comp06, Comp07, Comp08.
- Seminars and ABP: Con01, Con03, Con07, H/D01, H/D02, H/D03, H/D04, H/D05, H/D06, H/D07, H/D08, H/D10, H/D11, H/D13, H/D14. Comp01, Comp02, Comp03, Comp04, Comp05, Comp07
- Practices: Con03, H/D04, H/D05, H/D10, H/D12, Comp02.

The student must dedicate 40.5 face-to-face hours to the study of the topics and 72 hours to personal work.

Work regularly.

- The subject is supported through material and activities in the Virtual Classroom. Subject notifications are sent from the News Forum of said Virtual Classroom and students must make sure they can receive them. The MS Teams platform will be used for activities that require direct contact with the teacher such as grupal or individual titorial sessions.
- The subject requires prior knowledge of high school chemistry, physics and mathematics. Also sufficient knowledge of molecular biology and production of biopharmaceuticals.