Pharmaceutical Biotechnology and Biomaterials

Code:

MI074258

Acronym:

BIOFB

Keywords
Classification	Keyword
OFICIAL	Technological Sciences

Instance: 2019/2020 - 2S

Active?	Yes
Responsible unit:	Pharmaceutical Technology Laboratory
Course/CS Responsible:	MSc in Pharmaceutical Sciences

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MICF	23	Official Curriculum	4	-	3	52	81

Teaching language

Portuguese

Objectives

Know the concept of biotechnology: definition and main stages of development of biotechnology. Distinguish the various application areas of biotechnology and know the biotechnological processes. Give special emphasis to the Pharmaceutical Biotechnology.   Know the regulatory aspects and bioethical applied to the Pharmaceutical Biotechnology. Acquire a comprehensive knowledge about the various classes of biomaterials used in medicine, both in terms of its properties and its application. To achieve these objectives, the student must apply 108 hours of work (4 ECTS x 27 hours), which correspond to 22 h lectures and 22 h laboratory classes. The remaining hours, 2 h correspond to evaluation and the remaining 62 h correspond to study time / work.

Learning outcomes and competences

Students should especially be able to recognize the different therapeutic agents obtained by genetic engineering and hybridoma, as well as new therapeutic systems used for their administration. They should also distinguish between the various biomaterials (metallic, ceramic and polymeric) used for replacement or regeneration of tissues and organs.

Working method

Presencial

Pre-requirements (prior knowledge) and co-requirements (common knowledge)

Knowledge in the areas of molecular biology, genetics, microbiology and pharmaceutical technology

Program

THEORETICAL CLASSES 1. Presentation of the course 1.1. Objectives 1.2. Evaluation Methodology 1.3. Recommended reading 2. Definition of Biotechnology 3. Main stages of development of Biotechnology 4. Areas of application of biotechnology 4.1. Agriculture (Green Biotechnology) 4.2. Industry (white biotechnology) 4.3. Environment (blue biotechnology) 4.4. Health (Biotechnology red) 5. Fundamentals of Molecular Biotechnology 5.1. Recombinant DNA and hybridoma 5.2. Cloning vectors 5.3. Hosts 5.4. Bioprocesses 6. Biopharmaceuticals 6.1. Blood factors, hormones, growth factors, cytokines, enzymes, monoclonal antibodies) 6.2. Routes of administration of drugs obtained by biotechnological processes 6.3. Systems of controlled drug release achieved by biotechnological processes 7. Cell therapy 8. Gene Therapy (viral vectors and nonviral vectors) 9. Genomics, proteomics, bioinformatics, gene chips, biomarkers 10. Pharmacogenetics and pharmacogenomics 11. Polymers that respond to stimuli ("smart"polymers ) 12. Encapsulation of cells 13. Probiotics 13.1. Definition and therapeutic use  13.2.Production of dosage forms containing probiotics: powders; capsules, tablets, ovules, lozenges, gels, eye drops, pellets 13.3. Packaging and storage of dosage forms containing probiotics 14. Genetic testing 15. Regulatory aspects and bioethical 15.1. Agencies and regulatory bodies 15.2. Standardization in Biotechnology 15.3. Product safety 16. Biomaterials 16.1. Definition and types of biomaterials (metals, ceramics, polymers) 16.2. Application of the biomaterials (prosthetic materials, regeneration and bone cements, heart valves and blood vessels, materials for ophthalmology, for skin substitutes burnt) LABORATORIAL CLASSES 1. Explanation of laboratory work 2. Preparation of alginate microparticles containing albumin by extrusion / gelation and evaluation of the encapsulation efficiency 3. Preparation of microemulsions by emulsion / sonication and internal droplet size evaluation by laser diffraction 4. Preparation of microemulsions by high pressure homogenization and internal droplet size evaluation by laser diffraction 5. Preparation and characterization of hydrogels based on stimuli-responsive polymers 6. Oral presentation of research papers

Mandatory literature

Crommelin Daan J. A. 340; Pharmaceutical biotechnology. ISBN: 978-1-4200-4437-9
Kun Lee Yuan 340; Microbial biotechnology. ISBN: 978-981-256-676-8
Lima, N., Mota, M.; Biotecnologia. Fundamentos e aplicações, Lidel, 2003
Shayne Cox Gad; Handbook of Pharmaceutical Biotechnology, Shayne Cox Gad, 2006. ISBN: 9780470117118
Gary Walsh; Pharmaceutical Biotechnology: Concepts and Applications, 2007. ISBN: 978-0-470-01244-4

Teaching methods and learning activities

Classes using the lecture method and interrogative method. Laboratorial classes using the statement method and the realization of work related with subjects taught in the theoretical lectures.

keywords

Health sciences
Social Sciences, Commerce and Law > Basic programmes
General programmes > Basic programmes
General programmes > Basic programmes
General programmes > Basic programmes > Basic programmes
Health sciences

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	80,00
Trabalho laboratorial	20,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Apresentação/discussão de um trabalho científico	2,00
Frequência das aulas	20,00
Total:	22,00

Eligibility for exams

Attendance to 3/4 of the theoretical and laboratorial classes. 

Calculation formula of final grade

Final written examination is worth 16 points. Research work is worth 4 points. Students with a final grade equal to or greater than 9.5 are considered approved.

Examinations or Special Assignments

Written examination in special date for Erasmus students.

Special assessment (TE, DA, ...)

Written examination in special day for working students, association leaders and students at graduation.

Classification improvement

In accordance with the guidlines of the Standards Assessment FFUP for the academic year 2019/2020.

Observations

Students should have knowledge of Molecular Biology, Biochemistry, Microbiology, Pharmacology and Pharmaceutical Technology.

Changes in UC Pharmaceutical Biotechnology and Biomaterials resulting from the Covid-19 Contingency Plan

Theoretical classes

The program of theoretical classes was taught in its entirety with the following adjustments:

• From class no.9, the theoretical classes were at distance, either by making videos recorded, available on Moodle or by synchronous sessions on the Colibri-Zoom platform.

Laboratory classes

In laboratory classes, the research work was carried out in groups, at distance. The laboratory execution of the planned works was canceled, and a powerpoint was made available with a detailed explanation.

The research work was submitted until the 20th of May. The oral presentations and discussion of the works were carried out synchronously on the Colibri-Zoom platform, in 3 sessions.

Evaluation of the UC

• Research work submitted in Moodle: 6 values
• Synchronous presentation and discussion of the work: 4 values
• Remote theoretical exam (Moodle test): 10 values / duration 50 minutes
(The evaluation was carried out using mechanisms to guarantee academic integrity).
• Minimum grade in the theoretical exam: 4.5 values
• Minimum final grade for approval in the UC (Theoretical exam + Research work): 9.5 values
• Appeal exam through oral evaluation by videoconference at Colibri-Zoom platform.