Biopharmaceuticals in Clinical Practice

Recommended Prerequisites

All areas of life sciences (examples: Pharmaceutical Sciences, Medicine, Biochemistry or Biology).

Teaching Methods

Lectures: students actively engaged in the construction of knowledge, analyzing diverse information in the context of Biopharmaceuticals. Links between a professional context and exploited scientific concepts will thus be established.
Autonomous learning: students will be encouraged to, autonomously get actively involved in the construction and development of their knowledge, searching and analyzing information and solving problems, proposed (or not) by the teacher.
Problem-solving class: Presentation of papers selected within the themes of the lectures.

Learning Outcomes

Main learning outocomes are:
• underlying the therapeutic use of biopharmaceuticals in its pre-clinical and clinical aspects (eg, monoclonal antibodies, vaccines and recombinant proteins);
• the regulatory area of advanced technology and biotechnology-based medicines (biopharmaceuticals);
• the storage, dispensing and use in clinical practice of biologics;
The implementation of the objectives described will enable students to develop the following skills: organization and planning; manage information; problem solving; critical thinking; autonomous learning; oral and written communication; concern for quality.

Work Placement(s)

No

Syllabus

Pharmaceutical development of biological products;

Development of recombinant proteins

Handling and clinical trials of biopharmaceuticals

Biopharmaceuticals in diabetes

Biopharmaceuticals in rare diseases

Regulatory aspects of biopharmaceuticals.

Head Lecturer(s)

João Nuno Sereno Almeida Moreira

Assessment Methods

Assessment
Clipping presentation: 20.0%
Exam: 40.0%
Presentation: 40.0%

Bibliography

Pharmaceutical Biotechnology
Fundamentals and Applications
Crommelin, Daan J. A., Sindelar, Robert D., Meibohm, Bernd (Eds.)
4th ed. 2013, XXI, 544 p.
Molecular Biotechnology: Principles and Applications of Recombinant DNA Hardcover – November 1, 2009
by Bernard R. Glick (Author), Jack J. Pasternak (Author), Cheryl L. Patten (Author)
Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, 2nd Edition
Rodney J. Y. Ho (Volume Editor)
ISBN: 978-1-118-17979-6, 744 pages, November 2013, Wiley-Blackwell.