Chromatography: Purification Strategy for Biomolecules

Method Development and Scale-up
of Ion Exchange Chromatography

Three-day Course

Course Description

The goal of this interactive course is to provide an insightful overview of the fundamentals of process development and scale-up of ion-exchange chromatography. The primary focus is on experimental work concerning a scale-up model. This model provides tools for process optimization and successful scale-up of column-chromatographic operation units. Emphasis is also placed on understanding the most important parameters affecting ion-exchange chromatography.

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

Lectures and hands-on practical section
  • Basic principles of production chromatography
  • Column packing and testing
  • Purification strategies for biomolecules
  • Scale-up strategies
  • Troubleshooting
  • Quality and safety aspects
Learning Goals
  • Learn about preparative chromatography (vs. analytical chromatography) and chromatographic processes
  • Find out how to improve process economics by method optimization
  • Identify critical column-packing parameters
  • Become skilled at scaling-up a biopharmaceutical process
Who should attend?
    The course is designed for engineers, scientists, laboratory technicians and technical staff from the following areas:
  • Protein purification
  • Process development
  • Production development
  • Production optimization
  • Protein research
What will you receive?
  • A comprehensive course manual
  • Certificate of successful course participation
Ordering information
To register, please contact Andrea Bentz: stz-tb@hs-mannheim.de
Course Schedule and Program
Day 1: 12:00 - 17:45
  • Registration
  • Welcome
  • Basic principles of production chromatography
    • Non-linear vs. linear chromatography
    • Adsorption isotherms and distribution coefficients
    • Screening and selection criteria for resins
  • Manufacturing of biologics
    • Process examples for mAb, recombinant proteins and viruses
    • Chromatographic resins for cGMP production
  • Practical, part I
    • Dynamic IgG binding capacity
    • Static IgG binding capacity of different ion exchange materials
  • Analysis and discussion of results
    • Static vs. dynamic binding capacity
    • Important factors in ion-exchange chromatograph
  • Dinner
Day 2: 8.30 - 17:30
  • 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
  • Practical, part III
    • Optimization and scale-up of LGE
    • Prediction of step elution
    • Isoresolution curves
  • Analysis and discussion of results
Day 3: 9.00 - 15:15
  • 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
€850/person (+VAT) including dinner, refreshments and lunch during the course.
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, 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
  • Post-doc at Boehringer Mannheim, Penzberg, Germany (now Roche Diagnostics)
Dr. Bettina Katterle, Head of Marketing & Sales, BSL Bioservice Scientific Laboratories GmbH, Munich, Germany
  • 15 years of experience in protein production, purification, and analytical testing
  • Worked for 4 years as sales manager for biopharmaceutical services
  • Responsible for analytical methods as RP-, SE-HPLC, HPAEC-PAD, and capillary zone electrophoresis
  • Study Director for protein analytics/characterization since 2002
  • Scientist at Max-Planck Institute for Bioinorganic Chemistry
  • Post-doc at Arrhenius Laboratories, Department of Molecular Biology, Stockholm, Sweden,
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
Franz Nothelfer, Associate Director of Purification and Formulation Development, Boehringer Ingelheim Pharma GmbH & Co KG, Germany
  • Responsible for the development of novel downstream processes for therapeutic proteins and antibodies
  • Responsible for the establishment of new innovative techniques in purification
  • Joined the newly founded biotechnology group at Dr. Karl Thomae GmbH, a 100% subsidiary of Boehringer Ingelheim Pharma GmbH, in 1979 and started his career in protein chemistry and purification development for recombinant proteins and antibodies
  • Worked in different groups of the microbiology department at Dr. Karl Thomae GmbH since 1974
  • Joined Dr. Karl Thomae GmbH in 1971 as biology assistant