Acoustic Cell Processing

ekko™ Cell Processing System

The ekko™ cell processing system is a true fit-for-purpose cell therapy manufacturing solution employing acoustic technology suited for gentle-handling of patient and reference material.

  • Multi-use platform technology simplifies cell therapy manufacturing
  • Increased flexibility and utilization based on modular design
  • Gentle manipulation of cells imparts minimal energy and stress

ekko™ Cell Processing System

 

Feature Product Highlights

Concentration and Wash

Whether you need to process an apheresis product or are harvesting from a bioreactor, the ekko system processes continuously without interruption. Flexible control allows for a wide range of inputs and final concentrations as well as yields and processing times. This provides peace-of-mind knowing that cell viability is maintained due to the low energy acoustic forces. We have processed a variety of cell types, including:

  1. Apheresis material
  2. T cells
  3. Mesenchymal Stem Cells (MSCs)
  4. Pluripotent Stem Cells (PSCs)
  5. Keratinocytes
  6. Platelets
  7. Fibroblasts

T-Cell Harvest System Capabilities and Exemplar Results:

 

Process Inputs
Volume ≥120 mL
Viable Cell Density ≥0.75e6 T cells/mL
Total Viable Cells ≥0.75e9 T cells
Process Outputs
Volume ≥15 mL
Process Performance
Viable Cell Recovery 90% ± 5%
Viability <5% change
Throughput 3L/hr + 10-30 minute wash and collection
Wash Residuals >99%

Notes:

  • Viable cell recovery and viability determined using Nucleocounter NC-200 & flow cytometry
  • Wash residuals for BSA measured using ELISA assay, Interferon Gamma (IFN-γ) and Granulocyte-macrophage colony stimulating factor (GM-CSF) determined using Luminex
  • Exemplar process parameters include: 1 billion T cells in 1L with output of 80 mL

Aggregate Processing

  • The ekko™ system can be connected to your bioreactor of choice to enable a closed, integrated, and automated solution for your PSC aggregate expansion or differentiation process. The system is tunable to maximize single cell removal or aggregate retention at each step while being gentle minimizing cell residence time out of your bioreactor. Multiple unit operations can be performed such as:
    • Efficient media exchanges
    • Gentle aggregate harvest
    • Harvest of single cells
  • Perfusion
    • Imagine a perfusion process without the need of filters. Our acoustic technology can do just that. Contact us to learn more.

Aggregate Pluripotent Stem Cell Media Exchange System Capabilities and Exemplar Results:

 

Process Inputs
Volume ≥120 mL
Aggregate Cell Number ≥1e8 aggregate cells
Process Outputs
Volume ≥15 mL
Process Performance
Aggregate Recovery Tunable up to 99%
Viability <5% change
Throughput 4-6 L/hr
Single Cell Depletion Tunable up to 93%

Notes:

  • Aggregate recovery, single cell depletion & viability determined using ViCell
  • Exemplar process parameters include: 1 billion PSCs in 2L with output of 2L

Featured Resources

 

Interview

View our interview, Moving from Retrofitting to Made for Purpose Manufacturing Equipment, published December 2018, through Cell & Gene Therapy Insights.

In this interview, Nina Bauer, Head of Cell Therapy Commercial, and Richard Grant, Head of Acoustic Product Development, both with MilliporeSigma consider the following questions:

  • With the recent run of cell and gene therapy approvals and an ever-increasing level of investment into this sector, what do you see as the biggest developments that have enabled this progress to date?
  • What changes do you think are needed in order for this to grow into a scalable and sustainable industry?
  • What do you see as potential pressure points in the supply chain that will need to be addressed as the industry scales?
  • Cost of Goods continues to be a concern for cell and gene therapies – what are the key cost drivers and what steps can be taken to optimize them, thus potentially reducing the costs of these therapies?

 

Article

View our article, Novel equipment and process changes: implications for your manufacturing strategy.

In this article, we outline the main considerations from a broad GMP equipment compliance perspective, as well as indicating key resources and referencing guidelines for both Europe and the United States on how to navigate the regulatory aspects of manufacturing changes.

 

Webinars

View our webinar, Made-for-Purpose Manufacturing Solutions – The Key to Commercialization.

In this webinar, the team provides the latest data and developments on cutting edge novel bioprocessing tools. The team also discusses:

  • Manufacturing cost drivers and key risk factors to commercial success
  • Current State of Affairs in manufacturing technologies
  • How can we achieve commercially viable routine in manufacturing?
  • What is acoustophoresis and why is it important to cell processing?

 

View our webinar, Let’s Talk Integration, published December 2019 through Cell & Gene Therapy Insights.

This webinar provides a short example of the ekko™ system processing cell aggregates while integrated with a bioreactor. A cross-functional panel discuss integration challenges and learnings related to an integration strategy.

  • A comprehensive view of key considerations when implementing integrated solutions from the perspective of process development, automation and regulatory
  • First-hand examples of implementing automation strategies and technologies
  • When, where and how to consider implementing such technologies and the balance of risk / benefit

If you’re interested in learning more about our ekko™ cell processing system, please contact us.