Biopharmaceuticals

Objectives

-       Establishment of Animal Cell Technology as a key area in the discovery and development of complex biopharmaceuticals, including recombinant proteins (e.g., monoclonal antibodies), vaccines and viral vectors for gene therapy.

-       Relevance of stem cells as products of high therapeutic potential.

-       Development of skills in cell culture technologies as in vitro models for basic research and preclinical trials (e.g., primary cultures of brain cells and hepatocytes for toxicology testing).

-       Case studies and examples of biotechnological applications of Animal Cell Technology.

-       Impact of Animal Cell Technology in Pharma and Small Biotech companies.   

-       Commercial exploitation of the areas of animal technology and its contextualization in the biotechnology market.

General characterization

Code

11189

Credits

3.0

Responsible teacher

Available soon

Hours

Weekly - Available soon

Total - 48

Teaching language

Português

Prerequisites

BSc in Biochemistry, Biology, Biotechnology abnd related areas

Bibliography

“Culture of Animal Cells: A Manual of Basic Technique and Specialized Applications”, R. Ian Freshney, Wiley-Blackwell, 6th edition, 2010

Animal Cell Technology: From Biopharmaceuticals to Gene Therapy, Castilho, Morais, Augusto e Butler (Ed), Taylor and Francis Group (Pub)

Tecnologia do Cultivo de Células Animais de Biofármacos e Terapia Gênica, Morais AM, Castilho L, Augustos EP (Eds), Editora Roca (Pub)

Artigo científicos publicados em revistas internacionais da especialidade com elevado impacto, por exemplo, Nature Biotechnology, Trends in Biotechnology, Biotechnology and Bioengineering, Tissue Engineering, Journal of Biotechnology, Gene Therapy.

Teaching method

Theoretical classes where the basic theoretical principles of the discipline 
are taught using powerpoint presentations and direct interactions. 
Practical theoretical classes with exercises and discussion of case studies 
Practical/experimental laboratory class for students to have contact with the 
basic cell culture methodology
 

Evaluation method

Classification of the biopharmaceuticals: 
Continuous evaluation: 
Practice: Laboratory work with animal cells (at the end of the practical class, 
students deliver a report of no more than 3 pages with analysis of class results) 
THEORETICAL TEST (frequency) – April 20 from 3:00 pm to 5:00 pm (plus 30 minutes of 
tolerance); 

Global exam feature to be marked on the exams calendar. 

Students with tests classified above 9.5 are approved. 
All students must have more than 10 values ​​in the practical 
assessment (report and practice component in the exam test) 

Classification of the bipharmaceuticals course:  
85% (theoretical test) + 15% (continuous assessment of practical class and report report – 7.5% and the practical component test – 7.5%).
 

Subject matter

-        Basic principles of animal cell culture techniques, cellular immortalization and development of production cell lines.

-        Culture of animal cells in bioreactors, upstream, downstream and product characterization.

-        Production of biopharmaceuticals, vaccines, VLP''''s (Virus-Like Particles) and gene therapy vectors.

-        Introduction toGMP(Good Manufacturing Practices).

-        Animal cells as models in preclinical research.

-        Aspects of stem cell bioengineering and applications in cell therapy and as tools for biopharmaceuticals screening.