Scalable, xeno-free expansion of mesenchymal stem cells in a fixed-bed bioreactor

Scalable Xeno-Free Expansion of Mesenchymal Stem Cells in a Fixed-Bed Bioreactor: A Collaborative Case Study

Discover the transformative potential of scalable, cost-effective mesenchymal stem cell (MSC) manufacturing with insights from a collaborative study between Rooster Bio and Univercells Technologies. This comprehensive case study explores the successful transfer and expansion of MSCs in a fixed-bed bioreactor, highlighting key advancements in process efficiency, scalability, and cell quality.

Introduction to Rooster Bio and Univercells Technologies

Bill King, Director of Business Development at Rooster Bio, introduces the company's mission to fuel scalable advanced therapies. Founded in 2013 and based in Frederick, Maryland, Rooster Bio specializes in cGMP-grade media and cells supported by FDA master files, serving as critical raw materials in clinical trials. Their MSC 2.0 applications focus on gene-modified cells and extracellular vesicles, advancing therapeutic innovations while optimizing supply chains.

Dr. Thomas Robert, Senior Innovation and Property Manager at Univercells Technologies, presents their scalable bioprocess solutions, prominently featuring the scale-X bioreactor range. This fixed-bed bioreactor technology supports applications from R&D to clinical trials, offering linear scalability, reduced costs, and streamlined time-to-market for advanced therapies.

Key Highlights of the Case Study

• Seamless Process Transfer:
  • Rooster Bio’s best-in-class xeno-free MSC platform was successfully integrated into the scale-X hydro bioreactor.
  • The process involved initial cell expansion in flasks, followed by a 6-day bioreactor run using Rooster Nourish xeno-free media with scheduled replenishments.
• Optimized Cell Attachment and Growth:
  • Rapid cell attachment to the fixed bed within 60 minutes after inoculation.
  • Consistent metabolic activity observed through glucose consumption and lactate production, indicating robust cell growth.
• Advanced Bioprocess Monitoring:
  • Implementation of the Skaia vision software, a multi-factorial predictive model for estimating cell number based on specific physiological mechanisms, such as glucose consumption.
• Efficient Cell Harvesting:
  • Utilization of the scale-X cell collect module for optimized enzymatic detachment, supported by mechanical vibration.
  • Harvest yields improved across three runs through process refinements, with consistently high cell viability (>96%).
• Comprehensive Quality Assessment:
  • Extensive flow cytometry analysis confirmed the maintenance of MSC phenotype post-expansion.
  • Replating assays demonstrated excellent cell morphology and viability, while confocal microscopy provided insights into cell attachment and growth prior to harvest.

Key Takeaways:

Thanks to its scalable and cost-effective nature, scale-X bioreactors can be used as an efficient cell expansion platform for stem cells with Rooster bio’s xeno-free stem cells medium and reagents, showing successful process transfer and cell harvest while meeting the quality attributes.

Conclusion

This case study validates the scale-X bioreactor as an efficient, scalable platform for MSC expansion, offering a robust solution for therapeutic manufacturing. The collaboration between Rooster Bio and Univercells Technologies underscores the potential of integrated bioprocess innovations to advance the field of regenerative medicine.

This Video was published on behalf of and in collaboration with Univercells Technology and RoosterBio.