AUGUST 16- 17
Day One: 1:30 – 5:00 pm | Day Two: 8:30 am – 3:30 pm

Introduction to Downstream Processing

Introduction:

This activity-packed course focuses on the science, technologies and strategies needed to understand and implement an effective downstream process for biological development and production.

The course begins with an in-depth look at DSP design and development - from recovery to purification to formulation - before moving onto pertinent issues surrounding HTPD, single-use systems, continuous processing, PAT, CPPs, viral clearance, platform development and process validation. The course concludes with real-world examples from downstream development projects for both traditional and emerging modalities.

Course Outline:

Part 1: Intro and DSP Principles

• Process design: The first steps
• Development of purification strategies
• Interactions with cell culture
• Recovery to purification to formulation
• High throughput process development (HTPD)
• Single-use technologies

Part 2: Recovery and Purification

• Harvest step
• Virus clearance in downstream process of cell culture-based therapeutics
• Centrifugation
• Chromatography
• Purification using column chromatography, membrane chromatography, ultrafiltration
• Extraction

Part 3: Future Considerations and Challenges

• Process design & economics
• Process validation
• Quality by Design and Critical Process Parameters
• Continuous processing
• Analytics and PAT solutions

Workshop Leader:

Professor Jean-François Hamel, Academic researcher and Instructor, Chemical Engineering Department, Massachusetts Institute of Technology

Training Seminar Information:

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.