Bioengenharia e Produtos Biofarmacêuticos

Objectives

Acquisition and application of knowledge and skills regarding the manufacture of pharmaceuticals through biotechnology and bioengineering. Understanding of the meaning of the terms biological product, biopharmaceutical and products of biotechnology origin and of a set of concepts from the sources of obtaining these compounds, to their production and purification, regulation and entry into the market. The program aims to provide the student with a set of fundamental principles and concepts on cell and tissue cultures, bioreactors, biopharmaceutical production routes, quality, efficacy and safety criteria and respective regulation, using concepts ranging from bioengineering to biomedicine.

Syllabus

The programme covers the various stages required from the production of a biopharmaceutical product to its commercialization, including: - production in bioreactors, development of bioprocesses and scale-up (upstream); - processes for separation, purification and validation of biopharmaceuticals (downstream); - regulation, quality criteria and manufacturing of biopharmaceuticals and advanced therapies. Relevant topics in biopharmaceuticals are presented, such as the development of biomaterials and applications in medical devices, cell and gene therapy, immunogenicity and pharmacokinetics of monoclonal antibodies (reference and biosimilars).

Prerequisites

Any student that has been admitted to the following 2nd Cycle programmes are elligible to take this course: MEFARM, MEQ, MEBIOL, MEBIOM or MEAMBI.

Cross Competence Component

This course helps to understand the production and purification of biopharmaceuticals, as well as the regulation and legislation exercised by different international authorities on the Pharmaceutical Industry (of different types and located in different parts of the world). In terms of transversal skills, this means the development of skills in the interpretation of National and International Legislation on the pharmaceutical sector and the ability to consider different perspectives: societal, national and cultural.

Ethical Principles

All members of a group are responsible for the group’s work In any assessment every student shall honestly disclose any help received and sources used. In an oral assessment, every student shall be alble to present and answer questions about the entire assignment and solution.