Cell and Gene Therapy with the CellMaker Low Flow Bioreactor System

Cellexus airlifts cell and gene therapy research to new heights with the CellMaker Low Flow bioreactor system

In the era of rapid technology growth and increasingly booming discovery, medical research is one of the leading fields of innovation. In the last decade or so, researchers and innovators have turned their efforts to developing personalised therapy to tackle some of the most problematic medical conditions. From cancers and autoimmune diseases to chronic bacterial infections, an increasing number of patients benefit from medical treatments designed to their own needs. Among these approaches are treatments which use the patient’s own cells to aid their recovery by using autologous cells to deliver the necessary factors directly to the patient’s body. Using these cell and gene therapy approaches, the medical practitioners can avoid various complications, including transplant rejections or the use of immunosuppressant medication.

For these personalised therapies, based on the patient’s own cells, to work, the doctors need to extract the right type of cells from the patient’s body and cultivate them ex vivo. First the cells are conditioned in various ways to be able to perform their therapeutic task, and later grown in sufficient quantities to be delivered back to the patient. Although the cultivation methods for the first stages of this process are well known and have been used in research labs for a long time, the means of cell amplification in a safe, clean and economically viable way are still undergoing development and continuous improvement.

The Solution

Single-use technologies have become irreplaceable in their ability to scale, adapt and maintain a clean and efficient cell culture, which is compatible with the requirements of the medicinal preparation. At Cellexus, we have answered the call for a new cell cultivation system, which brings the benefits of a developed bioprocess to the cell and gene therapy arena, while remaining gentle and precise to satisfy the needs of a primary cell culture. We have modified our flagship single-use bioreactor system, the CellMaker Plus, to the needs of mammalian cell lines and we now present the new CellMaker Low Flow system. The CellMaker Low Flow delivers precise control over air flow to the CellMaker bag, at rates from 0.2 to 2 litres per minute, further reducing both hydraulic shear forces to the cells, and foaming of the media. Due to the unique design of the CellMaker bag, the CellMaker Low Flow still provides excellent media mixing and gas aeration as in the original CellMaker Plus systems. The flexibility of the CellMaker single-use bioreactor bags allow users to quickly adapt existing bioprocesses, or switch to a new one, without lengthy cleaning procedures. With the arrival of the Low Flow model, we can now decrease the downtime between batches with the availability of the new Hamilton OneFerm SU ARC pH sensors. These sensors have been tested and approved by our team for use with the CellMaker system and are available as an optional add-on with all CellMaker systems. Until now, the pH probes were the only fully reusable component of the CellMaker bioreactor. Now we can meet the expectations of the highly demanding biomedical industry by making the CellMaker solutions fully replaceable with no need of component sterilisation.

Further Development

The introduction of the CellMaker Low Flow system is the first step in our new and innovative product line aimed at the eukaryotic bioprocess, including the cell and gene therapy area. With a new 100L single-use bioreactor bag and system being developed, there is plenty of scope to expand our line of bags and accessories to further enhance the user experience with the CellMaker systems.

Current Research

The CellMaker Low Flow system has already been tested for growth and support of recombinant monoclonal antibody production in the CHO and Hybridoma cell lines. Further tests are ongoing with Jurkat cells and even some suspension plant cells are being grown in the CellMaker and the results will be published when these studies are completed. Finally, to enable growth of the adherent cells in the CellMaker, we have performed mock experiments with the use of a globular and fibrous microcarriers. Such microcarriers allow expansion of adherent cell lines while taking the full advantage of increased volume of a 3D suspension culturing system. We found that both types of microcarriers can be easily introduced into the CellMaker bag and are efficiently suspended by the stream of rising air bubbles of the airlift mixing system. As the adherent cells on a microcarrier tend to be even more sensitive to shearing than typical suspension cell lines, we believe the new CellMaker Low Flow will become the bioreactor of choice for applications, where limiting cell damage is essential.