BPE-34806 Pharmaceutical Biotechnology

Course

Credits 6.00

Teaching methodContact hours
Lecture24
Practical60
Group work2
Course coordinator(s)dr. ir. DE Martens
Lecturer(s)dr. ir. DE Martens
dr. ir. B Langelaan
K Hesp
ing. WAC Evers
ing. EJ van den End
N. Vriezen
Examiner(s)dr. ir. DE Martens

Language of instruction:

English

Assumed knowledge on:

BPE-22306 Basic Cell Factory Design; FHM-31806 Biotechnology 2

Contents:

Note: This course has a maximum number of participants. The deadline for registration is one week earlier than usual.
See Academic Year.(http://www.wur.nl/en/Education-Programmes/Current-Students/Agenda-Calendar-Academic-Year.htm) -> Registration for Courses.

Biopharmaceutical products (i.e. therapeutic proteins, vaccines, gene and cell therapies) are essentially different from other biotech products in the sense that it is a high value product with very specific requirements in terms of safety and efficacy, in short product quality. Biopharmaceutical process engineers require skills in management of process variance and subsequently variance in product quality while being in compliance with (GMP) regulations through understanding of the underlying (cellular) processes. In this course we will cover all aspects of biopharmaceutical development from cell line development, cell culture, purification, product analysis, quality control aspects and process engineering.

Learning outcomes:

After successful completion of this course students are expected to be able to:
- recall the steps in a pharmaceutical process development value chain;
- explain how the steps in a pharmaceutical process development value chain relate to process scale, GMP requirements and associated development costs;
- perform the following steps of a biopharmaceutical production process: cell culture, sterile handling of cells, bioreactor operation, product purification and analysis of cell viability, product-, nutrient-, metabolite- and cell concentration and product quality;
- apply the outcomes of these analyses to assess the state of the process and to design a strategy to adjust process parameters such as stirring, aeration or feeding when necessary;
- recall the specific physiological properties of animal cells that are relevant for biopharmaceutical process development;
- evaluate the relevance of different bioreactors and culture strategies for animal cell culture;
- design a bioreactor for animal cell cultivation based on biological and physical constraints;
- design a virus production process;
- optimize process settings based on knowledge on the relationship between process parameters and product formation and quality;
- explain how available process analytical tools for bioprocess monitoring can be used for process monitoring and control and discuss their value during process development and routine manufacturing of biopharmaceutical products;
- recall, explain and apply the principles of Quality by Design and other process quality systems in biopharmaceutical development, including calculations of key performance indicators.

Activities:

9 lectures (2 h each), Practical on CHO cell culture and product analysis, group assignment on quality by design for biopharmaceuticals

Examination:

Students obtain an individual grade for a final closed book exam and a group grade for the practical and the QbD case. The exam grade counts for 75% and the combined grade for the practical and cases for 25%. All grades have to be above 5.5. Grades are valid for a period of 5 years

Literature:

Reader, hand-outs, selected peer-reviewed papers.

ProgrammePhaseSpecializationPeriod
Restricted Optional for: MBTBiotechnologyMScA: Cellular/Molecular Biotechnology3WD
MBTBiotechnologyMScD: Process Technology3WD
MBTBiotechnologyMScC: Medical Biotechnology3WD