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Related Experiment Video

Updated: Dec 15, 2025

Recombinant Collagen I Peptide Microcarriers for Cell Expansion and Their Potential Use As Cell Delivery System in a Bioreactor Model
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Bioreactor Parameters for Microcarrier-Based Human MSC Expansion under Xeno-Free Conditions in a Vertical-Wheel

Josephine Lembong1, Robert Kirian1, Joseph D Takacs1

  • 1RoosterBio, Inc., 5295 Westview Drive, Suite 275, Frederick, MD 21703, USA.

Bioengineering (Basel, Switzerland)
|July 12, 2020
PubMed
Summary

A new bioreactor process enables large-scale manufacturing of human mesenchymal stem/stromal cells (hMSCs). This optimized method ensures cell quality and quantity for commercial cell therapy demands.

Keywords:
bioprocessbioreactorhMSCsmicrocarrier

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Area of Science:

  • Cell Biology
  • Biotechnology
  • Regenerative Medicine

Background:

  • Human mesenchymal stem/stromal cells (hMSCs) show therapeutic promise with over 900 clinical trials.
  • Commercial hMSC production requires large lot sizes (~100B cells), necessitating advanced manufacturing like 3D bioreactors.

Purpose of the Study:

  • To develop a scalable, cost-effective, and robust bioreactor process for clinical-grade hMSC manufacturing.
  • To optimize hMSC expansion in a suspension bioreactor system.

Main Methods:

  • Developed a fed-batch, microcarrier-based suspension bioreactor process.
  • Optimized parameters for inoculation, culture, and harvest stages.
  • Implemented a bioreactor feed strategy to replenish depleted mitogenic factors.

Main Results:

  • Achieved consistent hMSC densities of 2x10^5-6x10^5 cells/mL within 5 days without media exchange.
  • Maintained a final cell population doubling level (PDL) of 16-20.
  • Demonstrated process robustness across multiple hMSC donors, preserving cell characteristics and function.

Conclusions:

  • The developed fed-batch bioreactor process is scalable for commercial hMSC production.
  • This method enhances media productivity, reducing costs and labor.
  • The process yields high-quality hMSCs suitable for therapeutic applications.