Chromatography Fundamentals for Biologics Process Development - Day 1Monday, 3 November 2025

Module 1

General background

• Protein biochemistry review
• Overview of recombinant protein production
• Bioprocessing scales, markets, and importance of platforms

Chromatography fundamentals

• Chromatography resin sizes and material properties
• Introduction to adsorption isotherms
• Mass transport considerations
• Ligands and modes of separation
• Comparison of separation modalities

Module 2

Chromatography scaling principles

• Relationship of bed height and linear flow velocities
• Designing batch cycles and scales
• Overview of flow distribution
• Interpretation of chromatograms and troubleshooting

Examples of industrial processes and design

• Overview of platform processes and special considerations for novel modalities
• Column packing and qualification
• Common equipment – chromatography systems, columns, and pumps
• Separation challenges and understanding product vs. process related impurities
• Process design for facility fit
• Overview of analytics
• Applications for continuous manufacturing

Module 3

Mechanistic modeling

• Comparison of adsorption isotherm formalisms
• Isotherm calibration methods
• Transport property considerations and calibration methods
• Overview of modeling software
• Process development examples of mechanistic model strategies

Module 4

High-throughput process development

• Overview of high-throughput chromatography techniques
• Focus on plate based screening strategies
• Focus on RoboColumns and scale considerations

Strategies for linking high-throughput data with mechanistic models