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The next stage in manufacturing scale up...


With the market in allogeneic cell therapy expanding, drug developers are seeking more efficient manufacturing systems to gain a competitive edge. A major challenge here is scale-up – many early manufacturing processes use adherent (“2D”) systems, which are labor-intensive and not easily scaled. Many developers resort to ‘scaling out’ by using more culture vessels, but this adds a huge footprint and can lead to variability in cell quality, especially during seeding and harvesting.

We can help you meet the challenge of scale-up with our 3D manufacturing process. Developed with our extensive experience, this flexible bioreactor setup is centered on a universal controller, which can operate various single use vessels. 3D processes can be run with our proprietary perfusion capability. We also bring extensive microcarrier know-how.

This process can deliver quality through a controlled culture environment, quantity to meet demand, consistency between batches and efficiency with reduced hands-on time. With these benefits you can gain a competitive edge in this growing market.


Quality Quantity Consistency Efficiencies
  • Controlled culture environment
  • Optimized feeding
  • Shorter time from harvest to freeze
  • Meet lot size and total cell quantity demand
  • Batch to batch
  • Less manpower
  • Less time
  • Smaller footprint (~1:10)
  • Fewer deviations (e.g. particles, contamination, human error)
  • Fewer batches - less testing

Single-use vessels

  • Ease of use
  • Stirred tanks, stirred bags, rocker bags, other
  • 50L manufacturing scale

Universal controller

  • One controller for many vessel brands and formats
  • Streamlined development

Microcarriers

  • 1x50: replaces hundreds of multilayer stacks
  • Optional cGMP digestible carriers
  • Development experience

Perfusion

  • Stable cellular growth environment
  • Prevent spikes of nutrients and buildup of byproduct

Key applications of the 3D bioreactor process


We have developed expansion processes in 3D bioreactors for Mesenchymal Stem Cells (MSCs) and induced Pluripotent Stem Cells (iPSCs), two key cell types where scale-up is a challenge.

Current manufacturing processes in 2D adherent vessels for MSCs and iPSCs are manual, time consuming and require a large manufacturing footprint to achieve the cell numbers needed for commercial scale.

In our 3D bioreactor process, MSCs and iPSCs have high yields compared to cells grown using traditional 2D vessels. With this process we can increase your efficiency and reduce your production costs.

We can tailor our 3D bioreactor services to provide you the benefit from our technology, whatever your requirements are. We can generate custom 3D bioreactor processes depending on your product, cell type and program needs.