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Process Development: Driving Cell Therapy from Research to Market
Claire Wang
Claire Wang
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Process Development: Driving Cell Therapy from Research to Market

Exploring stem cell therapy with a focus on bioreactors and bioassays used for developing a scalable cell differentiation process.

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Thursdays
 at
11:00
A.M.
 ET /
8:00
A.M.
PT
8 weeks, 2-3 hours per week
Intermediate
No experience required
No experience required
Some experience required
Degree and experience required

Description

Cell therapy refers to the transplantation of autologous or allogeneic cells into patients to treat diseases or repair damaged tissues. However, the gap between research-scale proof of concept and clinical patient doses is significant and multifaceted. This build project aims to explore key aspects of bridging the gap between R&D and clinical application in stem cell therapy, focusing on scalable/automated cell differentiation process development and cell-based analytical techniques.

You will delve into various types of bioreactors and close-system cell processing instruments, get exposed to different analytical techniques for cell phenotyping and drug efficacy assessment, and conduct an experimental proposal using the design of experiment (DoE) concept. The project will also introduce the drug commercialization process from the perspective of CMC (chemistry, manufacturing, controls) team. You will draft master batch records and raw material risk assessments, documents required for ensuring the drug consistent productivity and quality. This comprehensive project will equip you with practical skills in designing and scaling-up cell differentiation processes, applying advanced cell-based analytical techniques, and preparing documents related to therapeutics safety and regulatory compliance.

Session timeline

  • Applications open
    September 5, 2024
  • Application deadline
    September 22, 2024
  • Project start date
    Week of July 8, 2024
    Week of
    October 7, 2024
  • Project end date
    Week of

What you will learn

  • Understand CRISPR-Cas9 genome editing technology used in cell therapy and the concept of process development.
  • Explore different cell characterization technologies and potency assays and perform experimental design.
  • Understand drug commercialization process and draft documents required for PD-MFG process transition.
Build Projects are 8-week experiences that operate on a rolling basis. Selected participants engage in weekly live workshops with a Build Fellow and 2-15 other students.

Project workshops

1
Cell Therapy Overview
2
Drug Commercialization Process
3
Process Development – Part 1
4
Process Development – Part 2
5
Cell-Based Analytical Techniques
6
Design of Experiment (DoE)
7
Transitioning from Process Development to Manufacturing
8
Process Development in Cell Therapy: A Recap

Prerequisites

  • A basic understanding of cell therapy: the knowledge of stem cell, including its regenerative ability and applications in medicine.
  • Familiarity with cell biology: cell types, cell cycle, cell differentiation (experience with cell culture is a plus).
  • A basic understanding of bioreactors and cell processing tools: their purpose, key functions, and types of equipment.

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About the expert
Claire Wang
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Claire
's Linkedin
A Senior Process Engineer with an MS in Bioengineering from Northeastern University. I'm proficient in driving iPSC-derived cell therapy programs (iNK Cells/iCART Cells/Muscle Cells) from the research scale to manufacturing. I have extensive hands-on experience with 70+ days of stem cell differentiation process development and scale-up, bioreactors (PBS Vertical Wheel/Xuri Wave Bioreactor/Spinner Flask), multicolor flow cytometry, immunofluorescence, and CMC-related documentation.