Purification of mAbs and related proteins:

Chromatographic methods, strategies and optimization

September 4-6, 2017

Course Description

This hands-on course provides a fundamental understanding of chromatographic methods and strategies to purify monoclonal antibodies and related molecules.

The combination of theoretical lectures, industrial case studies and experiments in the lab enables participants to gain a profound knowledge of biochromatography processes.

Venue

Steinbeis Transfer Center at Mannheim University of Applied Sciences

Paul-Wittsack-Str. 1068163 Mannheim, Germany

Email: stz-tb@hs-mannheim.de

Registration Info

Due to the hands-on nature of this course, enrollment is limited to 8 participants. We recommend early booking to ensure a place.

Course fee: 950,00 €

To register, please contact Mrs. Andrea Bentz, Assistant to Prof. Dr. C. Frech   (Email: stz-tb@hs-mannheim.de).

Course Content

  • Theory and application of Protein A, ion exchange and mixed-mode chromatography
  • Purification strategies for antibodies and related molecules
  • Case studies presented by experts from industry
  • Quality and safety aspects

Learning Goals

  • Designing robust chromatographic unit operations
  • Defining and optimizing suitable purification strategies
  • Evaluating the pros and cons of different techniques
  • Selecting analytical tools for process development
  • Understand and use all the tools needed to remove process impurities and contaminants

Who should attend?

  • Process development scientists
  • Chemical and biochemical engineers
  • R&D scientists and technicians
  • Professionals in areas related to antibody processing

What will you receive?

  • A comprehensive course documentation
  • Summary of experimental results
  • Certificate of participation

Course Schedule and Program

Day 1: Start 12 am

  • Registration and Welcome
  • Basic principles of antibody purification
    • Antibody structure
    • Protein A affinity chromatography
    • Antibody purification by ion exchange chromatography
    • Static and dynamic binding capacities
  • Practical part I
    • Capture of antibodies by Protein A affinity chromatography
    • Ion exchange chromatography for antibody purification
    • Determination of dynamic IgG binding capacities
    • Analysis and discussion of results
  • Dinner

Day 2: 8.30 am - 5.30 pm

  • Different chromatographic techniques for the purification of antibodies:
    • Hydrophobic interaction chromatography, hydroxyapatite & mixed mode chromatography, size exclusion chromatography
  • Case studies:
    • Regulatory aspects in protein purification and impurities testing (Dr. Bettina Katterle)
  • Practical part II
    Design of an antibody purification process
    • Purification strategies and sequencing of purification steps
    • Post-Protein-A – steps in antibody purification
    • Optimization of intermediate purification steps
    • Optimization of polishing steps

Day 3: 9 am - 16 pm

  • Case studies:
    • Production of monoclonal antibodies (Xavier Le Saoût)
  • Scale up in chromatography
  • Presentation and discussion of results
  • ourse summary and final discussion

Course Instructors and Industry Experts

Prof. Dr. Christian Frech, Steinbeis Transfer Centre at the University of Applied Sciences, Mannheim

Short Biography:

  • 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

Short Biography:

  • 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 KGaA, Darmstadt, Germany Healthcare, Corsier sur Vevey, Switzerland

Short Biography:

Xavier joined Merck KGaA, Darmstadt, Germany 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 KGaA, Darmstadt, Germany.

Dr. Lars H. Peeck, Senior Marketing Manager, Life Science, Merck KGaA, Darmstadt, Germany

Short Biography:

  • 2015-present: Senior Marketing Manager, Chromatography, Life Science, Merck KGaA, Darmstadt, Germany
  • 2014-2015: Group Leader, Chromatography media Research & Development + High Throughput Screening, Merck KGaA, Darmstadt, Germany
  • 2011-2014: Laboratory Head, Chromatography media Research & Development, Merck Millipore, Darmstadt, Germany

Dr. Lothar Jacob, Consultant, Darmstadt, Germany

Short Biography:

  • 2015-present: Consultant, Downstream Processing
  • 1992-2015: various Marketing roles within the Life Science Business of Merck KGaA, Darmstadt, Germany, focusing on Chromatography media development
  • 1987-1992: Laboratory Head Protein Purification, Max-Planck Research for Structural Molecular Biology at DESY, Hamburg, Germany