Human Mesenchymal stem cells (MSC), are the main players of cell therapy. They have the ability to differentiate, are highly flexible, and can lower inflammation, making them the best prospects for regenerative medicine. However, demand for MSCs significantly outnumbers supply. Pharmaceutical companies are rushing to create MSCs in commercial numbers while maintaining high-quality requirements. As the range of possible MSCs expands, the manufacturers are also increasing the large-scale production of MSCs.
Large-scale MSC production
Mesenchymal cells tend to be very sensitive to their surroundings. MSCs can show signs of senescence if they are cultured in 2D monolayers. Excessive handling greatly increases the risk of microbiological infection. Furthermore, experts are still divided on the appropriate cell density for growth, with different studies recommending different plating densities. In general, smaller seeding densities appear to encourage accelerated cell expansion. As a result, the cell culture technique takes less time and is less expensive. Simultaneously, cell cultures are less likely to become contaminated or to lose their unique functions.
Investigating other media, processes, and approaches
Cell growth may be stimulated by careful handling and various culture methods. Researchers are experimenting with several ways in order to preserve important functional properties of human mesenchymal stem cells and fully explore their therapeutic potential:
- Adopting 3D culture systems instead of traditional monolayers can assist overcome some of the constraints of 2D culture. A 3D system more closely simulates the in vivo condition as well as the physiological environment, both of which have a good effect on cellular functioning.
- It is possible to avoid xenogeneic responses by utilizing xeno-free standardized media. These include unexpected influences on MSC development produced by uncharacterized animal-derived culture additives. When developing safer and more consistent processes for creating therapeutic-grade cellular products, regulators recommend employing xeno-free alternatives.
- The use of bioreactors allows for cell expansion in a completely closed, regulated, and reproducible culture system. This is critical for large-scale MSC production in compliance with good manufacturing procedures (GMP) and quality standards. However, questions about the use of bioreactor systems remain, on how to choose the best harvesting method, how to rapidly concentrate large volumes of cell solutions without compromising cell survival and function, and when to seek alternative trypsin with newer enzymes that gently gather human MSCs from microcarriers.
- Opting for new cryopreservation procedures for the long-term storage of MSCs using nontoxic xeno-free supplements Cryopreservation is the only way to ensure that cellular products are available rapidly and in adequate quantity to build clinical-grade MSC banks for therapeutic uses.
Why are standardized protocols so important for mesenchymal stem cell therapy?
A framework of ground rules and boundaries is required for any novel therapy. As a result, many ongoing preclinical research projects are aimed at developing regulatory guidelines These rules ensure that producers generate MSCs in accordance with defined protocols, as medical professionals require consistent high-quality cellular products to obtain effective therapeutic effects
The path to cell therapy is nevertheless long. Despite several studies demonstrating that clinical use of human MSCs is safe, practical, and useful for specific instances and diseases, regulatory bodies have only licensed just a few commercialized products. The competition for commercial MSC-based medicines will undoubtedly accelerate in the coming decade. To keep up with the increased speed, the industry will need to quickly develop standardized processes and streamline output. Basic research will be critical in assisting the industry in overcoming today’s obstacles and paving the way for a successful clinical application.