Method Development and Scale-up
of Ion Exchange Chromatography
Three-day Course
This hands-on course introduces tools for the development and scale up of protein separations, focusing on ion exchange chromatography. The combination of theoretical lectures, industrial case studies and experiments in the lab enables participants to understand and use systematic models and methodologies to develop ion exchange unit operations and transfer these processes from lab to pilot plant or production scale.
Mannheim University of Applied Sciences
Paul-Wittsack-Str. 10
68163 Mannheim, Germany
Email: stz-tb@hs-mannheim.de
- Basic principles of protein purification and column chromatography
- Theory and Application of the linear gradient elution (LGE) model for optimization and scale-up of ion exchange chromatography
- Case studies presented by experts from industry
- Aspects of resin selection, column packing and large-scale manufacturing
- Understanding of process parameters critical to ion exchange chromatography at small and large scale
- Understanding of principles of gradient elution processes and the LGE model
- Practical optimization and scale up of ion exchange separations using the LGE model
- Process development scientists
- R&D scientists and technicians
- Process engineers involved in scale up and manufacturing of ion exchange chromatography unit operations
- A comprehensive course documentation
- Summary of experimental results
- Certificate of participation
- Registration and Welcome
- Basic principles of production chromatography
- Non-linear vs. linear chromatography
- Adsorption isotherms and distribution coefficients
- Screening and selection criteria for resins
- Important factors in ion-exchange chromatograph
- Manufacturing of biologics
- Examples of mAb, recombinant protein and virus processes
- Chromatographic resins for cGMP production
- Practical, part I
- Static and Dynamic IgG binding capacity in ion exchange chromatography
- Column performance testing (plate number, HETP, asymmetry)
- Analysis and discussion of results
- Dinner
- Introduction to linear gradient separation experiments (LGE)
- Practical, part II
- Design of gradient separations
- Influence of different parameters on the gradient separation of proteins
- Lunch
- Case study “Optimization and scale up of ion exchange separations” (Dr. Th. v. Hirschheydt)
- Practical, part III
- Optimization and scale-up of LGE
- Prediction of step elution
- Isoresolution curves
- Analysis and discussion of results
- Large-scale protein chromatography
- Column-packing demo and column performance testing
- Packing procedures, column design and troubleshooting
- Lunch
- Summary of course results and final discussion
For help with registration, hotel accommodation etc., please contact Mrs. Andrea Bentz, Assistant to Prof. Dr. C. Frech (Email: stz-tb@hs-mannheim.de).
For more information or to register for this course, please contact ilearn@merckgroup.com
Our highly skilled and qualified instructors are experts in chromatography, and combine technical knowledge with field experience and teaching capabilities. The balance between theory and practice extends to our instructors who do not spend all their time in the theoretical environment of the classroom; they are also working engineers who deal with real applications on a daily basis.
