Cell therapy takes big leap forward thanks to DuoGenic StemCells’ high-performance stem cell media

4 Dec

Driven by the development of biotechnology, modern healthcare has evolved towards precision medicine, gene therapy, and cell therapy. Among these applications, cell therapy has been recognized as a highly potential therapeutic approach in treating neurodegenerative diseases and cancers, as well as repairing human organs. Stem cell research plays a critical role in the development of cell therapy. However, the difficulty in stem cell culture has brought about many clinical practice challenges.

Initially Aims at Enhancing Academic Research Efficiency

To facilitate experimentation, Dr. Hong-Lin Su, a professor at the National Chung Hsing University and his team started to develop new cell culture media. In March 2018, they formed a company named DuoGenic StemCells through technology transfer. Within six months, the two stem cell media they developed have grabbed the market’s attention. Their cell media are expected to lead cell therapy into a brighter future.

A former student of Dr. Hong-Lin Su and the current CEO of DuoGenic StemCells, Chih-Yao Lin says cell therapy is not merely a slogan for people like them who have been devoted to stem cell research. Cell therapy is aimed to treat diseases, that can’t be cured with medication such as Parkinson’s disease, Alzheimer’s disease, and other neurodegenerative diseases, through the application of innovative technology. Cell therapy begins with cell culture to produce a large number of high-quality stem cells for experimental use and clinical applications, high-quality culture media and technology are essential.

Two Key Cell Culture Media

Located in a quiet alley in Taichung, home to Taiwan’s precision machinery industry, the plain-looking building of DuoGenic StemCells’ plant accommodates an ISO 14644-1 Class 3 cleanroom that produces more than 1000 bottles of stem cell culture media per day. The company can produce two kinds of culture media, one is the PLUTO ESC/iPSC cell media and the other is the AllPhase MSC cell media.

Different kinds of stem cells are generated in different ways and have various features and functions. For example, ESCs (Embryonic stem cell) can differentiate into neural cells, marrow cells, and pancreatic cells which can then be used to replace dying or dysfunctional cells inside patients.

iPSCs (Induced pluripotent stem cell) are a type of pluripotent stem cells (embryonic-like) that can be generated directly from adult cells. iPSCs, which are genetically matched to a particular patient, are used to generate tissue or organs outside the human body. The tissue or organs are then transplanted back into the patient. Theoretically, this method can reduce rejection risk and thus cure diseases caused by damaged cells.

MSCs (Mesenchymal Stem Cell) exist in bone mallow or umbilical cord tissue and can reproduce themselves while differentiating into skeletal cells, neuronal cells, fat, and liver cells.

Due to the large variety of stem cells and applications, the components of culture media vary by the type of stem cells. It took the team a lot of tests and effort to find the right mixture of proteins. Compared to other media on the market, that requires the use of fetal bovine serum, the xeno-free media developed by the team is more ideal for future clinical practice.

Test results show the performance of these two culture media is twice as high as that of other media on the market. Also, these two culture media support 3D suspension, culture that not only addresses the need for industrializing and automating cell manufacturing, but also makes stem cell production quicker and safer.

The PLUTO ESC/iPSC culture media and the AllPhase MSC culture media. Both use the mixture of proteins developed in house and contain no fetal bovine serum. The ability of 3D suspension culture makes these two culture media twice as fast as other media.

Targeting Clinical Practice with International Certification

The stem cell market consists of four segments: culture media, medium materials, instruments, and cell lines. Culture media are the largest segment with a market value of US$4.6 billion in 2018 and a CAGR of 6.9%. According to Chih-Yao Lin, culture media are mainly used for academic research; however, due to fierce market competition and price-sensitive customers, vendors need to put in a lot of marketing effort. Culture media for clinical trials must meet higher standards and have higher requirements for product specifications and certifications. Customers in this market segment tend to be more loyal and buy more of the product, thus bringing more profits to the vendors.  DuoGenic StemCells’ culture media not only has performance and cost advantages, but they can also meet future clinical needs. The company plans to obtain the ISO 13485 Certification – Quality Management Systems for Medical Devices this year and will initially target Taiwan’s B2B medical market.

The new regulations governing the management of specific medical examination techniques and devices provide a significant boost to cell therapy and stem cell research. Apart from cutting-edge medical technology, many biotech companies have been engaged in cell therapy. Chih-Yao Lin believes DuoGenic StemCells’ culture media will become a significant driving force for Taiwan’s biotech companies.  Through the collaboration between DuoGenic StemCells and biotech companies, cell therapy in Taiwan is going to thrive.

DuoGenic StemCells is expected to raise another US$1 million by late 2019 and increase the number of employees to 11 people. Besides continuing to develop stem cell culture media for different clinical practice, the company is also seeking to work with large channel players to tap into the Japanese, Chinese, and US markets. To this end, they have submitted a DMF (Drug Master File) to the FDA (Drug Master File), in addition to the application for ISO 13485 certification.

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