The Growing Field of Cell Therapies

The field of cell therapy is relatively new but has already garnered considerable attention and enthusiasm due to its potential as a therapeutic approach. While only a few companies are preparing for widespread Stem cell manufacturing, the industry’s pipeline boasts impressive prospects. Unlike traditional biopharmaceutical applications where cells secrete the desired product, cell therapy applications focus on the cells themselves as the therapeutic product.

Challenges in Cell therapy manufacturing: As a developing industry, several challenges associated with large-scale manufacturing require attention. Below mentioned are the major obstacles:

  • Scalability —The challenge of scaling up the manufacturing process becomes evident when working with adherent cells like mesenchymal stem cells (MSCs). As the number of cells required increases from billions to trillions, ensuring efficient and cost-effective production becomes crucial for successful commercialization.
  • Affordability — The ability to achieve large-scale production of stem cells in a cost-effective manner is imperative for achieving commercial success in the cell therapy industry. A key goal is finding efficient methods to meet this target while keeping costs reasonable.
  • Flexibility —The commercial success of the cell therapy industry relies on manufacturing flexibility, including the ability to schedule stem cell culture runs and rapidly and smoothly scale up operations. This flexibility is vital to adapt to changing demands and optimize production efficiency.
  • Closed systems —One of the essential requirements for commercial cell therapy manufacturing is the use of cGMP-compliant, aseptic closed systems. These systems allow for the growth of stem cells while maintaining compliance with regulations. They also enable automated cell culture processes that minimize stress on the cells.

One common method of stem cell cultures is cultivating them in tiny particles suspended in a bioreactor. This allows the cells to use the entire volume of the bioreactor and grow more evenly. However, keeping the microcarriers suspended and evenly distributed requires high agitation, which can damage the stem cells. Additionally, seeding and harvesting the stem cells from the microcarriers is challenging at large scales.

The CellBRx® bioreactor system offers several advantages over other bioreactor systems for Stem cell culture. It can keep the stem cells suspended in a gentle and efficient way, even at high cell densities. Once the above method is followed, the stress on cells is minimized and lets them attach and grow evenly. The CellBRx® system is also scalable from 1L to 200L, making it ideal for both early-stage process development and large-scale production.

OmniBRx Biotechnologies is continually working to improve the CellBRx® system for cell therapy applications. They are developing methods to scale the process to larger volumes and automate the harvesting process. They are also studying the use of the CellBRx® system with other cell types, such as induced pluripotent stem cells (iPSCs) and human embryonic stem cells (hESCs).

For Autologous Stem cell therapies, CellBRx 1L 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 cell therapy manufacturing, where large amounts of cells are needed, CellBRx®5L bioreactors are recommended. These systems can be automated for aseptic production and harvesting.

In simpler terms:

The CellBRx® bioreactor system is a better way to grow large amounts of stem cells than traditional methods. It minimizes damage to the cells and makes it easier to grow them evenly. The system is also scalable and can be used for both early-stage development and large-scale production.

OmniBRx Biotechnologies is constantly improving the CellBRx® system for cell therapy applications. They are working on scaling up the process, automating the harvesting process, and using the system with other cell types.

CellBRx® 1L microbioreactors are the best choice for autologous stem cell therapies, where individual patient cells are used. CellBRx® 5L bioreactors are the best choice for allogenic stem cell therapies, where large amounts of cells are needed.

To explore more about use of CellBRx bioreactors for cell therapy applications, click here.