Purification of Biomolecules

Method Development and Scale-up
of Ion Exchange Chromatography

Three-day Course

Course Description

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.

Catalog number: MANNHEIM01
Dates & Venue
Steinbeis Transfer Center at
Mannheim University of Applied Sciences

Paul-Wittsack-Str. 10
68163 Mannheim, Germany

Email: stz-tb@hs-mannheim.de

Course Content
  • 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
Learning Goals
  • 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
Who should attend?
  • Process development scientists
  • R&D scientists and technicians
  • Process engineers involved in scale up and manufacturing of ion exchange chromatography unit operations
What will you receive?
  • A comprehensive course documentation
  • Summary of experimental results
  • Certificate of participation
Course Schedule and Program
Day 1: Start 12:00 am
  • 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
Day 2: 8.30 am - 05:30 pm
  • 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
Day 3: 9.00 am - 04:00 pm
  • 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
Enrollment limited to 8 participants
Due to the hands-on nature of this course, enrollment is limited to 8. We recommend early booking to ensure a place.
Price
€1050/person

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

Course Instructors and Industry Experts
About our instructors

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.

Prof. Dr. Christian Frech, Steinbeis Transfer Centre at the University of Applied Sciences, Mannheim
  • 2004-present: Director of Steinbeis Transfer Center
  • Since 2004: Head of the Institute for Biochemistry at Mannheim University of Applied Sciences
  • March 2002: Appointment as Professor for Bioanalytics at Mannheim University of Applied Sciences
  • 1996–2002: Head of Pilot Plant Protein Purification, Process Development department at Chiron Behring, Marburg, Germany (now GSK Vaccines GmbH)
  • Post-doc at Boehringer Mannheim, Penzberg, Germany (now Roche Diagnostics)
Dr. Bettina Katterle, Head of Marketing & Sales, BSL BIOSERVICE Scientific Laboratories GmbH, Planegg, Germany
  • 2013-present: Head of Marketing & Sales, BSL BIOSERVICE Scientific Laboratories GmbH for biological safety and activity testing
  • 2009-2013: Sales Specialist Biopharmaceutical Services, Charles River Laboratories, Erkrath, Germany
  • 2002-2009: Scientific Officer (GMP) in Protein chemistry, NewLab GmbH, Erkrath, Germany
  • 2000-2002: Research Scientist at Max-Planck Institute for Bioinorganic Chemistry
  • Post-doc at Arrhenius Laboratories, Department of Molecular Biology, Stockholm, Sweden
Xavier Le Saoût, Associate Manager BioProcess Sciences, Merck Healthcare, Corsier sur Vevey, Switzerland

Xavier joined Merck 13 years ago to work primarily in the downstream pilot-scale development group to support technical transfer activities to manufacturing scale. In 2007, he integrated a new team in charge of pre-formulation activities and process intermediate stability studies. In 2010, he took the head of this team and contributed to the process development of several Mabs from lab scale until technical transfers to manufacturing. Since 2015, he manages a team in charge of evaluating innovative DSP technologies to define next generation purification processes for Merck.

Dr. Lothar Jacob, Consultant, Darmstadt, Germany
  • 2015-present: Consultant, Downstream Processing
  • 1992-2015: various Marketing roles within the Life Science Business of Merck, focusing on Chromatography media development
  • 1987-1992: Laboratory Head Protein Purification, Max-Planck Research for Structural Molecular Biology at DESY, Hamburg, Germany
Dr. Thomas von Hirschheydt, Principal Scientist, Roche Diagnostics GmbH, Penzberg, Germany
  • 2007-present: Group Leader in Biologics Research -Downstream Process Research and Supply, Diagnostics GmbH, Penzberg, Germany
  • 2003-2007: Group Leader in Medicinal Chemistry and High Throughput Purification, Diagnostics GmbH, Penzberg, Germany
  • Post-doc in Medicinal Chemistry, Roche Diagnostics GmbH, Mannheim and Penzberg, Germany