Cambridge Healthtech Training Seminars

Cambridge Healthtech Training Seminars


Thursday, AUGUST 18 - Friday, AUGUST 19
Day 1 2:00-5:15 PM • Day 2 8:30 AM-3:15 PM

(TS7) 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:

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

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