Downstream Processing 

Component code / course code: (PBT14_BAV/BAP)

Semester: winter / summer

ECTS credits: 8

Lecture hours per week (SWS): 8

Lecturer: Prof. Dr. Hans Kiefer

Course language: English

Prerequisite: Lecture "Downstream Processing (Recommended).

Objectives (Learning Outcome): Students who have successfully completed this module

  • know the processing of proteins and other biopharmaceutical active substances from different sources
  • can describe how their degree of purity is determined, how critical contaminants are detected and removed
  • can pick which methods are suitable for different tasks in each case. 
  • have been given an overview of methods used in the processing of biopharmaceuticals, especially proteins, on a laboratory and industrial scale  and can choose the appropriate methods themselves in specific cases. 
  • Use chromatography and filtration techniques in the laboratory to purify and analyze recombinant proteins from different sources.
  • have learned how to use the chromatography system (ÄKTA pure) independently. They can pack columns and check their packing quality.

Lecture topics (content):

  • Overview of multi-stage purification processes
  • Cell harvesting, preparation of a lysate; centrifugation and microfiltration techniques.
  • Chromatography: IEX, SEC, HIC, RPC, AC
  • Ultrafiltration, diafiltration, adsorber membranes
  • Separation of DNA, viruses, endotoxin, host cell proteins (HCPs) and product-related contaminants
  • Special purification techniques: extraction from aqueous multiphase systems, radial flow chromatography, continuous chromatography, precipitation and crystallization
  • Design and implementation of PAT (Process Analytical Technologies) and QbD (Quality by Design)
  • Set-up and operation of the ÄKTA-pure chromatography systems

Teaching format (e.g. online/in person lecture/Seminar/Lab etc.): Lecture / Lab

Examination: Written examination