An Introduction to Pharmaceutical Biotechnology
This online medical course aims to provide an overview of all aspects of pharmaceutical biotechnology for those with a biomedical or pharmaceutical background who want to learn more about this topic.
The course starts with the introduction of several biopharmaceutical products (BPs) that are currently on the market and then describes how the drug substances present in these products were actually obtained and produced by means of living cells. Topics such as gene cloning, cell line development, bioprocessing, and downstream purification methods will be discussed as well as formulation and delivery issues of recombinant proteins and nucleic acids. Furthermore, attention will be given to the registration process of BPs as well as to the cost-benefit analysis and the socio-economic impact these often pricy drugs might have.
Elevate Health and the University of Utrecht work jointly in offering this online course on Pharmaceutical Biotechnology. Development of this course was generously supported by the EU Lifelong Learning Programme in the project ‘Competences for industrial pharmacy practice in biotechnology – PHAR-IN’ (grant nr. 538252-LLP-1-2013-1-BE-ERASMUS-EKA).
By the end of this course, you will be able to:
- Sum up the main milestones in the history of biotechnology and pharmaceutical biotechnology in particular
- Distinguish different categories of biopharmaceutical products (BPs)
- Analyse and explain the structural organisation of BPs
- Set up a molecular cloning strategy for the recombinant production of therapeutic proteins in cells
- Rationally choose the appropriated host cell system for the large-scale production of protein-based BPs
- Explain the basic issues on protein stability
- Describe important techniques for and analytical challenges in protein characterisation
- Make a rational choice of the appropriate separation techniques for a given recombinant protein
- Explain the basic issues on protein stability and how this can be influenced through proper fomulation
- Explain how biopharmaceutical aspects of BPs can be influenced
- Describe the procedure for getting BPs registered
- Understand the social, economical and ethical impact biopharmaceuticals can have on patients and the healthcare system in general
Introduction to Pharmaceutical Biotechnology
We will start by looking at the history of pharmaceutical biotechnology. Topics will be the development of biotechnology, different categories of biopharmaceuticals. the structural organisation of biopharmaceuticals, the basics of molecular cloning and protein expression systems.
Production of Biopharmaceuticals
The next step is to discuss the production of biopharmaceuticals, which involves topics like protein stability, formulation, protein characterisation, separation techniques and viral clearance.
Biopharmaceutical Aspects of Biopharmaceutical Products
Later in the course we will discuss the biopharmaceutical aspects of biopharmaceutical products (BPs). Topics will be: immunogenicity and factors that can influence the pharmacokinetics and pharmacodynamics of BPs.
Regulatory Apects of BPs
Last but not least were going to discuss how you can get a proteins drug registered. Topics are the role of regulatory bodies and regulatory offices, RA aspects of BPs and ethical and economic implications.
- Introduction to Pharmaceutical Biotechnology
You will need the following books to participate in the course:
Pharmaceutical Biotechnology: Fundamentals and Applications
Prof. dr. D.J.A. (Daniel) Crommelin
Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs
Rodney J. Y. Ho
The books will be made available for free through the online portal of Utrecht University nearer the start date of the course.
The whole course will take place online. The following learning methods will be used:
- Web lectures
- Reading articles / book chapters
- Discussion forums
- Individual assignments
- Group assignments
To successfully complete this course, you need to actively participate in the discussion forums and complete the learning unit assignments, including:
- A group assignment you will be working on during the entire course. The grade for this assignments counts for 40%.
- A final test which involves short answer questions and counts for 60% in your final grade for the course.
- To pass the course your grades for the group assignment and for the final exam need to be a 6 or higher. When you do not pass the course, you are allowed to follow the course a second time for half of the tuition fee.
A basic knowledge in molecular & structural biology, biochemistry, pharmacology and immunology (bachelor level) is required in order to be able to follow this course. In principle, everyone with a biomedical background should have no problems in understanding the content of this online course.