Graduate Development and manufacturing of Biopharmaceutical and other Biotechnological products

The aim of the  course is to describe the required activities for the development  and manufacturing of Biotechnological products such as recombinant proteins, monoclonal antibodies or  extracts treated as New Biotechnological entities, Biosimilars or ingredients  in the Pharmaceutical, Medical Device, cosmetic, Fine chemistry and Agro-food sectors.

Bioprocess and analytical development and manufacturing of Biotechnological products
Block I: Cell Banking and Upstream processing (40h)
•    Strain/Cell line development and Cell Banks
•    Fermentation Development
•    Primary product recovery
•    Training in lab (20 h)

Block II: Downstream processing (40h)
•    Purification Development
•    Training in lab (20 h)

Block III: Analytical and Formulation development (40h)
•    Analytical development for process development, structural analysis, routine manufacturing and release.
•    Formulation  development and stability studies
•    Training in lab (20 h)

Block IV: Manufacturing of Biological products (20h)
•    Pilot and large scale Manufacturing of Biological products
•    Fill and finish
•    Quality control

Block V Case studies (20h)
•    Case study 1:  Development and manufacturing of a recombinant  protein in a microbial host
•    Case Study 2: Development and manufacturing of a monoclonal antibody in CHO

To BSc, MSc, PhD, or professional with expertise in some of the following areas: Biotechnology, Biology, Pharmacy, Engineer or Food and / or Veterinary.