1. General information
Course:
PHARMACEUTICAL BIOTECHNOLOGY
Code:
14334
Type:
CORE COURSE
ECTS credits:
6
Degree:
376 - UNDERGRADUATE DEGREE PROGRAMME IN PHARMACY
Academic year:
2023-24
Center:
14 - FACULTY OF PHARMACY
Group(s):
10
Year:
4
Duration:
C2
Main language:
Spanish
Second language:
English
Use of additional languages:
English Friendly:
Y
Web site:
Bilingual:
N
Lecturer:
MARIA FRANCISCA GALINDO ANAYA
- Group(s):
10
Building/Office
Department
Phone number
Email
Office hours
Facultad de Farmacia 2.17
CIENCIAS MÉDICAS
967599200
maria.galindo@uclm.es
Monday to Wednesday 16:00-19:00. Confirm appointment by email
Lecturer:
JOAQUIN GONZALEZ FUENTES
- Group(s):
10
Building/Office
Department
Phone number
Email
Office hours
Facultad de Farmacia AB. Despecho 3.8
CIENCIAS MÉDICAS
2236
joaquin.gfuentes@uclm.es
Monday to Wednesday 16:00-19:00. Confirm appointment by email
Lecturer:
MARIA VICTORIA LOZANO LOPEZ
- Group(s):
10
Building/Office
Department
Phone number
Email
Office hours
Facultad Farmacia. 2.4
CIENCIAS MÉDICAS
8238
mvictoria.lozano@uclm.es
Monday to Wednesday 16:00-19:00. Confirm appointment by email
Lecturer:
MANUEL JESUS SANTANDER ORTEGA
- Group(s):
10
Building/Office
Department
Phone number
Email
Office hours
Facultad Farmacia. 3.1
CIENCIAS MÉDICAS
2239
manuel.santander@uclm.es
Monday to Wednesday 16:00-19:00. Confirm appointment by email
2. Pre-Requisites
There are no prerequisites, but it is recommended:
Basic training in Structural and Metabolic Biochemistry to know the characteristics and properties of chemical products, bases of the physical and physicochemical processes necessary in the sequence of operations for the manufacture of medicines.
Basic training in Immunology and Microbiology necessary for understanding new therapeutic strategies in the design of vaccines and monoclonal antibodies.
Basic training in Molecular Biology which will be necessary for a better understanding of new experimental modalities such as gene therapy, stem cell treatments and antisense nucleotides.
Basic training in Pharmaceutical Technology I and II which will be necessary for the understanding of the formulation processes of biotechnological drugs.
If there are any changes in the schedule due to unforeseen circumstances, students will be notified of such changes through the virtual campus.
3. Justification in the curriculum, relation to other subjects and to the profession
Pharmaceutical Biotechnology is a discipline that provides the knowledge for the design and development of new medicines such as biotechnological medicines.
These include faster, more effective and safer medicines and personalised treatments through the use of active ingredients produced through the use of recombinant DNA technology, the design of biotechnological vaccines together with the knowledge of new therapies (cellular, gene therapy).
All these characteristics are related to subjects such as Biopharmacy and Pharmacokinetics, Pharmaceutical Technology I and II, leading the student to acquire the necessary training to successfully deal with the administration of drugs with effective, safe and stable pharmaceutical forms.
4. Degree competences achieved in this course
| Course competences | |
|---|---|
| Code | Description |
| B01 | Proficiency in a second foreign language at level B1 of the Common European Framework of Reference for Languages. |
| B02 | Knowledge of Information and Communication Technologies (ICT). |
| B03 | A correct oral and written communication |
| B04 | Ethical commitment and professional deontology. |
| B05 | Ability to develop those learning skills necessary to undertake further studies. |
| EB01 | Know the structures of biomolecules and their transformations into the cell. |
| EB03 | Estimate the biological risks associated with the use of substances and processes of laboratories involved. |
| EB05 | Develop skills to identify therapeutic targets and biotechnological production of drugs, as well as the use of gene therapy. |
| EB06 | Know and understand the microbiological control of medications |
| EFT01 | Using statistical analysis applied to pharmaceutical sciences |
| EFT02 | Apply both computational and data processing techniques, for getting information about physical, chemical and biological data |
| EFT03 | Know the processes of release, absorption, distribution, metabolism and excretion of drugs, and factors that condition the absorption and disposal according to their routes of administration. |
| EFT04 | Evaluation of scientific data related to medicines and health products |
| EFT05 | Using statistical analysis applied to pharmaceutical sciences |
| EFT06 | Design, optimize and elaborate the pharmaceutical forms guaranteeing their quality, including the formulation and quality control of medicines, the development of master formulas and officinal preparations. |
| EFT07 | Able to apply the quality control process to medical devices, dermopharmaceutical and cosmetic products and package materials. |
| EFT10 | Demonstrate knowlege of the physicochemical and biopharmaceutical properties of drugs and excipients, as well as the possible interaction between them |
| G01 | Identify, design, obtain, analyze, control and produce drugs and medicines, as well as other products and raw materials of sanitary interest for human or veterinary use. |
| G04 | Design, prepare, supply and dispense medicines and other products of health interest. |
| G13 | Develop communication and information skills, both oral and written, to deal with patients and users of the centre where they carry out their professional activity. Promote the capacity to work and collaborate with multidisciplinary teams and those related to other health professionals. |
| G14 | Know the ethical and deontological principles according to the legislative, regulatory and administrative provisions governing professional practice, understanding the ethical implications of health in a changing social context. |
| G15 | Recognise own limitations and the need to maintain and update professional competence, with particular emphasis on self-learning of new knowledge based on scientific evidence. |
| T01 | Critical thinking skills based on the application of the scientific method |
| T02 | Ability to manage quality scientific information, bibliography, specialized databases and resources accessible through the Internet. |
| T03 | Handling of basic and specific software for the treatment of information and experimental results. |
| T04 | Motivation for quality, safety at work and awareness of environmental issues, with knowledge of the internationally recognised systems for the correct management of these aspects. |
| T05 | Organizational, planning and implementation skills. |
| T06 | Ability to address human resources decision-making and management. |
| T07 | Ability to work as a team and, where appropriate, exercise leadership functions, encouraging entrepreneurship. |
| T08 | Develop interpersonal skills and the ability to function in an international and multicultural context. |
5. Objectives or Learning Outcomes
| Course learning outcomes | |
|---|---|
| Description | |
| Understanding the checks necessary to ensure the quality of pharmaceutics skin products, sanitary products, and cosmetics. | |
| Ability to work under standards of good laboratory practice (GLP). | |
| Ability to design a pharmaceutical laboratory in response to their facilities and processes necessary to ensure the quality of the products manufactured. | |
| Ability to plan, design and develop preformulation studies of the different pharmaceutical forms and to interpret the results. | |
| To know and to develop good manufacturing practiques (GMP) for the different activities to develop in Pharmaceutical Industry, pharmacy and hospital Pharmacy Service. | |
| Understanding the mechanisms of production of drugs using genetic recombination technology. | |
| Know and understand the fundamentals of the Pharmaceutical Technology | |
| Develop drugs regarding its qualitative and quantitative composition and select the optimal technological processes to be used in its manufacture. | |
| Additional outcomes | |
| Not established. |
6. Units / Contents
-
Unit 1: INTRODUCTION TO PHARMACEUTICAL BIOTECHNOLOGY
-
Unit 1.1: INTRODUCTION TO PHARMACEUTICAL BIOTECHNOLOGY
-
-
Unit 2: BIOTECHNOLOGICAL TOOLS
-
Unit 2.1: Concepts. Omic sciences in biotechnology. Data mining and bioinformatics.
-
-
Unit 3: VACCINES AND BIOTECHNOLOGY
-
Unit 3.1: Obtaining vaccines by biological methodologies.
-
Unit 3.2: Genetically engineered vaccines.
-
-
Unit 4: MONOCLONAL ANTIBODIES
-
Unit 4.1: Introduction. Antibody engineering. Generation of human monoclonal antibodies. Mechanism of action.
-
-
Unit 5: BIOTECHNOLOGICAL MEDICINAL PRODUCTS. BIOEQUIVALENCE. BIOTHERAPY.
-
Unit 5.1: Biotherapy and biotechnological medicinal products. Legal regulation of biotechnological medicinal products. Biosimilar medicines. Biosimilars versus innovators.
-
-
Unit 6: BIOTECH DRUGS
-
Unit 6.1: Insulin
-
Unit 6.2: Growth Hormone, Interferon and Haematopoietic Growth Factors.
-
-
Unit 7: BIOTECHNOLOGICAL BIOSENSORS
-
Unit 7.1: Technological bases involved in detection processes.
-
Unit 7.2: Biosensors. Applications in the diagnosis and treatment of diseases. Applications in industry.
-
-
Unit 8: PRE-FORMULATION OF BIOTECH PRODUCTS
-
Unit 8.1: Biomaterials. Classification and strategies to modulate their properties.
-
Unit 8.2: Preformulation of biotechnological products. Chemical and physical instability. Strategies in early stage preformulation.
-
-
Unit 9: FORMULATION OF BIOPHARMACEUTICALS
-
Unit 9.1: Development of liquid formulations of biotech products.
-
Unit 9.2: Drying methods for biotech products: spray drying and freeze drying.
-
-
Unit 10: NANOTECHNOLOGY AND BIOTECHNOLOGY
-
Unit 10.1: Nanoparticles and microparticles in biotechnology: general concepts and applications for the oral route.
-
Unit 10.2: Nanoparticles and microparticles in biotechnology: other routes of administration.
-
-
Unit 11: GENE THERAPY
-
Unit 11.1: Formulation in gene therapy: active ingredients and their formulation in viral and synthetic vectors.
-
-
Unit 12: TISSUE ENGINEERING
-
Unit 12.1: Concepts and strategies in tissue engineering. Application of tissue engineering for tissue and organ reconstruction.
-
-
Unit 13: PHARMACOKINETICS OF BIOTECHNOLOGY PRODUCTS
-
Unit 13.1: ADME processes in biotechnological therapy
-
Unit 13.2: Pharmacokinetic characteristics of protein and peptide therapy I
-
Unit 13.3: Pharmacokinetic characteristics of protein and peptide therapy II
-
Unit 13.4: Pharmacokinetics of monoclonal Antibodies
-
Unit 13.5: Pharmacokinetic characteristics of vaccines
-
Unit 13.6: Pharmacokinetic characteristics of gene and cell therapy
-
7. Activities, Units/Modules and Methodology
| Training Activity | Methodology | Related Competences (only degrees before RD 822/2021) | ECTS | Hours | As | Com | Description | |
| Class Attendance (theory) [ON-SITE] | Combination of methods | B01 B02 B03 B04 B05 EB01 EB03 EB05 EB06 EFT01 EFT02 EFT03 EFT04 EFT05 EFT06 EFT07 EFT10 G01 G04 G13 G14 G15 T01 T02 T03 T04 T05 T06 T07 T08 | 1.44 | 36 | Y | N | The availability of teaching resources will be accessible on the Moodle platform before the start of the activities. In addition, students will have access to complementary bibliographic and audiovisual material (books, review articles, videos) in the university library on the Albacete campus. The teaching methodology through the combination of methods will contemplate the expository method/lecture together with case studies. Active student participation in face-to-face teaching in workshops and seminars will be assessed using ICT tools. Cooperative work both in and out of the classroom will be materialised in the preparation and defence of assignments as well as in the resolution of problems and/or cases that will be presented orally. The marks obtained in these activities will be taken into account in the final assessment of the course. | |
| Class Attendance (practical) [ON-SITE] | Practical or hands-on activities | B01 B02 B03 B04 B05 EB01 EB03 EB05 EB06 EFT01 EFT02 EFT03 EFT04 EFT05 EFT06 EFT07 EFT10 G01 G04 G13 G14 G15 T01 T02 T03 T04 T05 T06 T07 T08 | 0.8 | 20 | Y | Y | Practical teaching will be given in small groups within periods established in the academic calendar that do not coincide with other teaching activities. They will be carried out in classrooms and/or laboratories, all of which are equipped with the appropriate means to achieve the proposed objectives. These activities are MANDATORY, so that the student will not be able to pass the course if they are not carried out properly. | |
| Study and Exam Preparation [OFF-SITE] | Self-study | B01 B02 B03 B04 B05 EB01 EB03 EB05 EB06 EFT01 EFT02 EFT03 EFT04 EFT05 EFT06 EFT07 EFT10 G01 G04 G13 G14 G15 T01 T02 T03 T04 T05 T06 T07 T08 | 3.6 | 90 | Y | N | Students may request personal tutorials on the contents of the subject by arranging an interview in advance with the corresponding teacher. | |
| Formative Assessment [ON-SITE] | Assessment tests | B01 B02 B03 B04 B05 EB01 EB03 EB05 EB06 EFT01 EFT02 EFT03 EFT04 EFT05 EFT06 EFT07 EFT10 G01 G04 G13 G14 G15 T01 T02 T03 T04 T05 T06 T07 T08 | 0.16 | 4 | Y | Y | Specific dates have been set aside in the academic calendar for assessment tests that do not coincide with other teaching activities. | |
| Total: | 6 | 150 | ||||||
| Total credits of in-class work: 2.4 | Total class time hours: 60 | |||||||
| Total credits of out of class work: 3.6 | Total hours of out of class work: 90 | |||||||
As: Assessable training activity Com: Training activity of compulsory overcoming (It will be essential to overcome both continuous and non-continuous assessment).
8. Evaluation criteria and Grading System
| Evaluation System | Continuous assessment | Non-continuous evaluation * | Description |
| Test | 70.00% | 70.00% | Theoretical knowledge is evaluated, as well as its application to the resolution of problems and practical cases. |
| Laboratory sessions | 20.00% | 20.00% | Attendance to the practical laboratory classes is compulsory. The grade obtained will account for 20% of the final grade for the subject. The application in the laboratory of the knowledge previously learnt, the student's attitude and the adequate preparation of the laboratory notebook individually will be assessed. The practical notebook will be graded as PASS/FAIL. It is essential to obtain a PASS in the practical notebook in order to pass the practical block of the subject, whose final grade will be the grade obtained in the practical exam. In the event that the student does not pass the practical block in the ordinary exam, he/she will have another opportunity in the final exam of the extraordinary exam to pass the subject. Once the practical block has been passed, the grade obtained will be retained for the following two academic years. |
| Assessment of active participation | 10.00% | 10.00% | The lecturer advises the student to regularly attend the face-to-face activities during the course. The resolution of questions and problems by the student, the presentation and public defence of work, as well as their active participation and attitude in class and tutorials will be positively valued. These activities are not compulsory. |
| Total: | 100.00% | 100.00% |
According to art. 4 of the UCLM Student Evaluation Regulations, it must be provided to students who cannot regularly attend face-to-face training activities the passing of the subject, having the right (art. 12.2) to be globally graded, in 2 annual calls per subject , an ordinary and an extraordinary one (evaluating 100% of the competences).
Evaluation criteria for the final exam:
-
Continuous assessment:In this modality, the subject will follow a continuous evaluation system, adapted to the regulatory norms of the University of Castilla-La Mancha.
The final grade will take into account, proportionally, the average of the written tests (70%), the completion of laboratory practices (20%)
and participation in seminars or other activities proposed in class (10%).
It will be assumed that all students opt for the continuous modality, unless otherwise informed (non-continuous modality) by means of a
email addressed to the professor responsible for the subject until 50% of all the evaluable activities have been completed or the
class period has ended.
The subject will be passed as long as a final average grade equal to or greater than 5 out of 10 is obtained among the different blocks (Theoretical, Practical and
Stake). It will be possible to add the marks obtained from the Theoretical and Practical block from a mark of 4 out of 10.
THEORETICAL MODULE EVALUATION (70% of the final mark). It will consist of a partial test (continuous assessment) and a final test. Both may
include theoretical concepts, topics covered in practices or in different teaching activities, problems or clinical cases, etc. The student who
pass a 4 in the partial test, you can decide whether to take an exam for the entire subject, or eliminate the contents corresponding to the partial test
to the final test, in this case each test will have a value of 50%. This decision will have to be notified to the professor responsible for the subject via
email at least 2 weeks before the date of the second final test. In order to be able to add the note corresponding to the theoretical block
of the subject through continuous evaluation, a minimum grade of 4 must be obtained in each of the tests.
PRACTICAL MODULE EVALUATION (20% of the final mark). Attendance at practices is MANDATORY. It will be evaluated by presenting a
laboratory notebook and a knowledge test, although the attitude in the laboratory, compliance with safety regulations and management of
residues may also be considered in the qualification. To pass the practical module, a qualification of AT LEAST 5 POINTS must be obtained in order to keep it for the following two academic years. The
The grade may be kept for the following two academic years, if the student so states in writing to the responsible professor. For
To be able to choose to add the grade from the practical block to the rest of the blocks, a minimum grade of 4 must be obtained in this block of the subject.
EVALUATION OF THE ACTIVITIES MODULE (10% of the final mark). Its evaluation will be in the classroom by carrying out the proposed activities
by the teacher. They are NON-MANDATORY. It will only be taken into account once the theoretical-practical block has been passed. The rating can be
retain it for the next two academic years, if the student states so in writing to the responsible professor. If a student could not
carry out any of the evaluable activities of the block of activities in person, for justified reasons, you can ask the teacher for the
carrying out another non-contact activity, of which they will be evaluated, to achieve the competencies.
In the event that the student does not reach the grade required to pass the ordinary call, and has to take the extraordinary one, the qualification of the
Theoretical and practical blocks can only be retained if a minimum score of 4 points has been reached. The activity note is not subject to this rule.
It is recalled that the material prepared by the teacher and made available to students on the Virtual Campus platform is the property of the teacher,
so taking it out of that context and making it available to people outside that platform will be considered plagiarism. Likewise, carrying out
different tests with unauthorized aid or material will be considered fraud. In accordance with the provisions of the Evaluation Regulation of the
student, the test in which fraud has been detected will be considered invalid and will be graded with fail (0), including as a fraudulent act
any type of plagiarism detected. -
Non-continuous evaluation:The subject can follow a non-continuous evaluation system, adapted to the regulatory norms of the University of Castilla-La Mancha.
The final grade will take into account, proportionally, the average of the written tests (70%), the completion of laboratory practices (20%)
and participation in seminars or other activities proposed in class (10%).
The subject will be passed as long as a final average grade equal to or greater than 5 out of 10 is obtained among the different blocks (Theoretical, Practical and
Stake). It will be possible to add the marks obtained from the Theoretical and Practical block from a mark of 4 out of 10.
THEORETICAL MODULE EVALUATION 70% of the final mark. It will consist of 1 FINAL TEST that may include theoretical concepts, practical cases,
problems etc
PRACTICAL MODULE EVALUATION (20% of the final mark). Attendance at practices is MANDATORY. It will be evaluated by presenting a
laboratory notebook and a knowledge test, although the attitude in the laboratory, compliance with safety regulations and management of
residues may also be considered in the qualification. To pass the practical module, a qualification of AT LEAST 5 POINTS must be obtained and the
The grade may be kept for the following two academic years, if the student so states in writing to the responsible professor.
EVALUATION OF THE ACTIVITIES MODULE (10% of the final mark). Its evaluation will be in the classroom by carrying out the proposed activities
by the teacher. They are NON-MANDATORY. It will only be taken into account once the theoretical-practical block has been passed. The rating can be
retain it for the next two academic years, if the student states so in writing to the responsible professor. If a student could not
carry out any of the evaluable activities of the block of activities in person, for justified reasons, you can ask the teacher for the
carrying out another non-contact activity, of which they will be evaluated, to achieve the competencies.
In the event that the student does not reach the grade required to pass the ordinary call, and has to take the extraordinary one, the qualification of the
Theoretical and practical blocks can only be retained if a minimum score of 4 points has been reached. The activity note is not subject to this rule.
It is recalled that the material prepared by the teacher and made available to students on the Virtual Campus platform is the property of the teacher,
so taking it out of that context and making it available to people outside that platform will be considered plagiarism. Likewise, carrying out
different tests with unauthorized aid or material will be considered fraud. In accordance with the provisions of the Evaluation Regulation of the
student, the test in which fraud has been detected will be considered invalid and will be graded with fail (0), including as a fraudulent act
any type of plagiarism detected.
Specifications for the resit/retake exam:
The final grade will take into account, proportionally, the average of the written tests (70%), the completion of the laboratory practices (20%) and the
participation in seminars or other activities proposed in class (10%).
The subject will be passed as long as a final average grade equal to or greater than 5 out of 10 is obtained among the different blocks (Theoretical, Practical and
Stake). It will be possible to add the marks obtained from the Theoretical and Practical block from a mark of 4 out of 10.
THEORETICAL MODULE EVALUATION 70% of the final mark. It will consist of 1 FINAL TEST that may include theoretical concepts, practical cases,
problems etc
PRACTICAL MODULE EVALUATION (20% of the final mark). For those students who have failed the practical module, they will be able to repeat the exam
of practical knowledge in the EXTRAORDINARY CALL. A grade of AT LEAST 5 POINTS is required to pass the practical module and keep it for the following two academic years.
EVALUATION OF THE ACTIVITIES MODULE (10% of the final mark). THE QUALIFICATION OBTAINED DURING THE CALL IS MAINTAINED
ORDINARY. It will only be taken into account once the theoretical-practical block has been passed. The qualification can be kept during the two academic years
following, if the student manifests it.
It is recalled that the material prepared by the teacher and made available to students on the Virtual Campus platform is the property of the teacher, for
taking it out of that context and making it available to people outside of that platform will be considered plagiarism. Likewise, the realization of the different
Testing with unauthorized aid or material will be considered fraud. In accordance with the provisions of the Student Assessment Regulations, the test in
the one that has been detected fraud will be considered invalid and will be qualified with suspense (0), including any type of plagiarism as a fraudulent act
detected.
participation in seminars or other activities proposed in class (10%).
The subject will be passed as long as a final average grade equal to or greater than 5 out of 10 is obtained among the different blocks (Theoretical, Practical and
Stake). It will be possible to add the marks obtained from the Theoretical and Practical block from a mark of 4 out of 10.
THEORETICAL MODULE EVALUATION 70% of the final mark. It will consist of 1 FINAL TEST that may include theoretical concepts, practical cases,
problems etc
PRACTICAL MODULE EVALUATION (20% of the final mark). For those students who have failed the practical module, they will be able to repeat the exam
of practical knowledge in the EXTRAORDINARY CALL. A grade of AT LEAST 5 POINTS is required to pass the practical module and keep it for the following two academic years.
EVALUATION OF THE ACTIVITIES MODULE (10% of the final mark). THE QUALIFICATION OBTAINED DURING THE CALL IS MAINTAINED
ORDINARY. It will only be taken into account once the theoretical-practical block has been passed. The qualification can be kept during the two academic years
following, if the student manifests it.
It is recalled that the material prepared by the teacher and made available to students on the Virtual Campus platform is the property of the teacher, for
taking it out of that context and making it available to people outside of that platform will be considered plagiarism. Likewise, the realization of the different
Testing with unauthorized aid or material will be considered fraud. In accordance with the provisions of the Student Assessment Regulations, the test in
the one that has been detected fraud will be considered invalid and will be qualified with suspense (0), including any type of plagiarism as a fraudulent act
detected.
Specifications for the second resit / retake exam:
Only students who meet the requirements set out in the Student Assessment Regulations of the University of Castilla-La-Mancha will be eligible for this call and will be assessed in accordance with the criteria applied in the extraordinary call.
9. Assignments, course calendar and important dates
| Not related to the syllabus/contents | |
|---|---|
| Hours | hours |
| Class Attendance (theory) [PRESENCIAL][Combination of methods] | 36 |
| Class Attendance (practical) [PRESENCIAL][Practical or hands-on activities] | 20 |
| Study and Exam Preparation [AUTÓNOMA][Self-study] | 90 |
| Formative Assessment [PRESENCIAL][Assessment tests] | 4 |
| Global activity | |
|---|---|
| Activities | hours |
10. Bibliography and Sources
