BIOLOGICS AND BIOPHARMACEUTICALS
Corso
A Padova
Hai bisogno di un coach per la formazione?
Ti aiuterà a confrontare vari corsi e trovare l'offerta formativa più conveniente.
Descrizione
-
Tipologia
Corso
-
Luogo
Padova
The examination at the end of the course aims to test the student's ability knowledge and understanding of all aspects related to the discovery and use of a biological. To this end, the exam will be a written test (multiple choice).
Sedi e date
Luogo
Inizio del corso
Inizio del corso
Opinioni
Programma
Differences between biologicals and small molecules
Market and development of biological drugs.
General principles of biotechnological processes applied to the production of proteins for therapeutic use.
Molecular biotechnologies.
Legal and regulatory requirements for biologics (EMA, FDA). Good Manufacturing Practices (GMP) for biotechnology drugs.
Biological expression systems and selection criteria.
Master and Working Cell Banks.
Innovative processes and organization of industrial biological production.
Upstream processes and technological innovation: single use bioreactors
Downstream processing in biological production.
Classes of contaminants.
CMC factors, Immunogenicity. Aggregation. Glycosylation.
Biologicals approval as orphan drugs.
Biosimilars, biobetter and next generation biologicals.
Classes of biologics: Monoclonal antibodies, soluble receptors, cytokines, growth factors, enzymes, hormones.
Notes on the main classes of biotechnological drugs based on nucleic acids.
Hai bisogno di un coach per la formazione?
Ti aiuterà a confrontare vari corsi e trovare l'offerta formativa più conveniente.
BIOLOGICS AND BIOPHARMACEUTICALS