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Wednesday 5th November 2025
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Wednesday 5th November 2025
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Chromatography Fundamentals for Biologics Process Development
Tech Transfer for Biopharmaceutical Manufacturing
14:00 - 17:00
Chromatography Fundamentals for Biologics Process Development - Day 3
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 softwares
- 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
- John Welsh - Principle Consultant, Rivanna Bioprocess Solutions LLC
13:00 - 16:00
Tech Transfer for Biopharmaceutical Manufacturing - Day 1
- Delegate introduction: specific expectations
- Definition of Tech Transfer in this context.
- When does TT occur in drug life-cycle (R&D to process development, post-approval changes to implement a new process, need for additional manufacturing capacity or strategic reasons).
- Tech transfer as a Project with Challenges : objectives, stakeholders, deliverables and success criteria project phases, resources, planning : tasks and milestones, documentation , risks, reporting
- Thomas Chattaway - Senior Life Science Consultant, Self-Employed
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- Chromatography Fundamentals for Biologics Process Development - Day 1
- Chromatography Fundamentals for Biologics Process Development - Day 2
- Wednesday 5th November 2025
- Thursday 6th November 2025
- Tech Transfer for Biopharmaceutical Manufacturing - Day 3
- CMC Roadmap - Day 1
- CMC Roadmap - Day 2
- Bioprocess Characterisation, Qualification And Validation - Day 1
- Bioprocess Characterisation, Qualification and Validation - Day 2