1. Introduction: Regenerative Medicine in Taiwan
Taiwan is famous for its semiconductor, night markets and pearl milk tea. But few people know that the public health insurance, medical technique and cell therapy are also flourishing.
In 2018, Taiwan government partially lifted the regulation on cell therapy with a positive list according to the “Regulations of Special Medical Techniques”. The permitted cell types include autologous immune cell (NK, CIK etc.), chondrocyte, fibroblast, ADSC and BM-MSC for specific indications respectively.
The cell therapy has been really popular in Taiwan since then. In fact, more than 300 projects have been approved, and more than a thousand patients have received these cell therapies up to date. The Market Size of regenerative medicine in Taiwan was valued at USD 30 billion in 2023, with CAGR of 10 ~ 15 % from 2023 to 2030.
2. AllPhase, the GMP grade MSC culture medium developed by DuoGenic StemCells corporation
Without a doubt, cell culture medium is a vital ancillary material in cell therapies, and DuoGenic StemCells corporation (DuoGenic) has dedicated to popularize cell therapy by manufacturing high-quality and certified cell culture medium.
After acquired the ISO 13485 certification, DuoGenic has developed and launched a GMP grade MSC culture medium: AllPhase in 2019. AllPhase is formulated for MSC expansion, and it’s in great demand by universities, medical research institutes and biotech companies. Soon after, AllPhase has then been adopted and approved in the cell therapy project of using BM-MSC for spinal cord injury.
“It’s been quite challenging at the beginning, to go from laboratory to set up a GMP factory. All the process needed to be verified, and all the ingredients needed to be inspected to meet the quality standards.” Dr. Chih-Yao Lin, CEO of DuoGenic said.
“Step by step, we’re building up our know-how, reputation and becoming a robust supplier in regenerative medicine. Hopefully more patients can be benefited by cell therapies.”
Beside the autologous cell therapy and stem cells, MSC derived exosome (or EV) has been another focus since 2010. Many have predicted that exosomes can be the next big thing in regenerative medicine. Without cells, the possibility of allogenic application can be increased. However, the challenges remain, especially when someone wants to increase the purity of the exosome, while maintain the cells in a healthy condition.
Last year, DuoGenic also launched an exosome specific MSC culture medium: DuoEXO. With its low nano-particles, MSC can still be healthy in DuoEXO, which make it great for collecting and studying MSC derived exosome.
3. First in the world coating-free hPSC culture medium: DuoESy
Dr. Hong-Lin Su, founder and the president of DuoGenic has been working with stem cells for over 20 years. Dr. Su saw the potential in human pluripotent stem cells (hPSC), and had joined the research team in “RIKEN”, Japan in the 2000s. The foundation has been laid for his research in hPSC since then.
Although theoretically, hPSC has the ability to self-renew and divide into an infinite number of cells, there are still two major obstacles when it comes to scale up: cell attachment and 3D proliferation in bioreactor.
Because of their poor attachment ability, hPSC won’t be able to adhere to the culture plate unless it’s pre-coated with protein or macromolecule. Without ECM pre-coated, hPSC will be suspended and spherical shapes might form. When the hPSCs are suspended and in a spherical shape, the inner and outer parts are in different growing conditions, this will result in cell differentiation and thus poor hPSC quality.
The procedure for pre-coating is rather complicated and not easy to verify in clinical application. Furthermore, the protein used in pre-coating is either from animals or recombinant Laminin, which is not easy to manufacture thus very expensive.
Other than that, when scaling up adherent cells, micro-carriers are often used, as these cells are not easy to grow in large bioreactors. How to grow hPSC on these micro-carriers remain a problem. And the key to the problem is how to make hPSC attach and grow normally without pre-coating.
To solve this problem, DuoGenic has developed DuoESy, the coating-free hPSC culture medium. Without pre-coating procedure, hPSC can attach to the culture plate and expand normally.
These hPSC remain pluripotent and a normal karyotype over long term culture in DuoESy. It’s worth mention that DuoESy is xenogeneic-free and offer a weekend-free culture option. With the assist from National Taiwan University, it’s demonstrated that the hPSC cultured using DuoESy remain the ability to differentiate into cardiomyocytes. The research was recently published in the international journal: Cell Transplantation.
DuoGenic is promoting DuoESy and looking for business partners, end users and distributors around the world. Tryout the cutting-edge hPSC culture system right now by contacting: info@duogenicsc.com
References:
https://journals.sagepub.com/doi/10.1177/09636897231198172
https://www.dgsc.com.tw/cell-culture-medium/