Cell Therapies Application
The cell therapy industry is still young but has already generated significant interest and excitement around the potential therapeutic value of its products. At the moment, there are only a handful of companies readying themselves for large-scale commercial manufacturing, but the industry pipeline is impressive and sizable. The main difference between cell based therapies and traditional biopharmaceutical applications (in which cells secrete the product of interest) is, in cell therapy applications cells are the product.
As a developing industry, there are still many challenges related to large scale manufacturing that need to be addressed. Some of the key challenges include the following:
- Scalability — During commercialization, adherent cells such as mesenchymal stem cells (MSCs) present a manufacturing challenge as lot sizes increase from billions to trillions of cells
- Affordability — achieving a single lot sizes of several trillions of cells efficiently and cost effectively will be essential and imperative for commercial success
- Flexibility — manufacturing flexibility (both in scheduling culture runs and capacity for rapid and linear scale-up) is vital to the commercial success of the cell therapy industry
- Closed systems — one of the essential requirement in commercial cell therapy manufacturing is growing stem cells in cGMP compliance and aseptic closed systems which allow the grown cells to be harvest with automation and without causing much of stress to the cells.
One of the common approaches for large volume production of stem cells is to grow them on microcarriers suspended in a bioreactor to utilize its entire volume and provide more uniform culturing conditions for the cells to maintain cell homogeneity. To maintain suspension and homogeneity of the microcarriers, especially at high densities of microcarriers, it requires increased agitation to maintain uniform suspension of carriers. Thereby, the stem cells grown on the microcarriers get shear damage from turbulent fluid motion and friction of colloidal carrier particle. In addition, uniform stem cell seeding and harvesting the cultured stem cells from porous surfaces of microcarriers pose another challenge to be resolved by bioprocessing researchers while scaling up the technology.
The CellBRx Bioreactor Systems offers unique advantage over other bioreactor systems in its ability to keep the stem cells in support matrix during culture at low agitation rate with gentle and efficient mixing. While imparting low shear stress on the cultured cells, the DBR technology provides large surface area of the fibrous cell-carriers that allows cells to attach quickly and evenly distributed.
Scalability of the DBR design has also been demonstrated using hMSCs and stem cell culture medium, resulting in consistently high growth rate in CellBRx 2/10 system. Although the CellBRx bioreactors are linearly scalable from 0.25 to 500L culture volume, these systems are ideal for early-stage process development, as they require smaller quantities of expensive reagents to perform screening studies.
OmniBRx Biotechnologies is continually working to generate remarkable and significant results in the CellBRx Bioreactor System for Cell Therapy application, including process scale-up to larger working volumes, as well as development of in-situ harvesting methodologies. Other cell lines such as induced pluripotent stem cells (iPSC) and human embryonic stem cells (hES) are also being studied in the CellBRx Bioreactor Systems.
For Autologous Stem cell therapies, CellBRx 0.2/0.5 Microbioreactors are the most preferred devices among the cell therapy providers since multiple single-use bioreactors can be installed and operated in single controller system and individual patient’s cells (personalized medicines) can be independently grown, manipulated and harvested from the disc scaffolds aseptically while complying with stringent cGMP requirements.
For allogenic stem cell therapy applications where large amount of stem cells is required to be grown and harvested aseptically with process automation, we recommend the CellBRx 2/10 Bioreactor Systems.
To explore more about use of CellBRx bioreactors for cell therapy applications, click here.