Press Center

Taiwan has nurtured the world's only cell factory - How does Dr.Signal Biotech replicate the semiconductor contract manufacturing miracle with CDMO?

Taiwan has nurtured the world's only cell factory - How does Dr.Signal  Biotech replicate the semiconductor contract manufacturing miracle with CDMO?

In recent years, Taiwan's biotechnology industry has been actively pursuing Contract Development and Manufacturing Organization (CDMO) services, sparking a wave of contract manufacturing. Cell therapy is seen as a future emerging therapy, and Dr.Signal Biotech has become the only biotech company in Taiwan and even globally with quantified and standardized cell processes.  Dr.Signal Biotech's founder and chairman, Dr. Mi Hsin-Wu, pointed out that the CDMO business has turned profitable, and it is expected to officially contribute revenue and enter a profitable state in 2024. It is not only in Taiwan but also globally the first biotech company to achieve profitability through cell process CDMO.

The CDMO model is similar to the semiconductor industry's wafer foundry, but in the past, the term "contract manufacturing" often carried negative connotations. However, with TSMC becoming an important partner in the global semiconductor industry, it has proven the value of the contract manufacturing business model. Before founding Dr.Signal Biotech, Dr. Mi Hsin-Wu was a dentist and found that various treatments could not overcome aging problems, so he tried to overcome the barriers of cell aging and regeneration. Currently, Dr.Signal 's core business is mainly based on cell application technology, which can be applied to regenerative medicine or cell therapy in the future.

 Different from other biotech companies focusing on drug development CDMO, the value created by Dr.Signal Biotech's cell process CDMO goes far beyond this. Including the large amount of carbon dioxide required for cell processes, Dr.Signal expands the positive and negative carbon conversion technology, which can help manufacturing and industry reduce carbon emissions, and even be used for carbon credit trading. This has become Dr.Signal's second cash cow apart from its main business. Furthermore, this has led to the establishment of "Mi Cell," aiming at future green economic opportunities. The derivatives of cell processes can also be applied to non-invasive medical aesthetics, as well as cell-cultured meat production.

 The prospects for cell therapy are vast -Dr.Signal seizes the discourse power of CDMO 

Although cell therapy is an emerging therapy, Dr. Mi Hsin-Wu pointed out that for the cell industry to develop rapidly, it must rely on process automation rather than manual cell culture. Dr.Signal independently developed the key 3A-GTP technology, which combines AI, AR, and AUTO. Compared with traditional GTP laboratories, cell production can be increased by ten times, and the cost of preparing one billion cells is only one-tenth of traditional manual culture.

 The biotech industry has high economic value, but AI development is still in its infancy. NVIDIA CEO Jensen Huang previously stated that life sciences will be the next big thing, and the future track lies in bioengineering. It's understandable why Huang, standing at the peak of the AI ​​wave, said so, as generative AI benefits various industries, reducing the need for so many talents. From the perspective of biotech, Dr. Mi Hsin-Wu also agrees with Huang's statement.

 He believes that there are still too many unknown areas in bioscience, which is completely different from using AI to write copies or design. If AI is applied in bioscience, biotechnology, and biomedicine, the added value will be much higher than it is now. Dr. Mi Hsin-Wu also frankly stated that the industry emphasizes the brain rather than the hands. Therefore, it is one of the industries that most need to automate and rely on AI for tedious procedures. But currently, let alone AI, the biotech industry still has a gap in digital transformation.

 Dr. Mi Hsin-Wu stated that Dr.Signal is the first company in Taiwan and even globally to have standardized mass production processes for cell preparation. All production equipment is independently developed and produced, and process integration with AI and big data is an important infrastructure for the digital transformation of the biotech industry. Dr. Mi Hsin-Wu also joked that in recent years, TSMC has gone abroad to establish factories, educating the global market on the contract manufacturing model. He also looks forward to CDMO being an important engine for promoting the development of the biotech industry.

Seizing the hardware dividend first to win first - The "database advantage" drama is yet to come

However, the real drama of cell preparation CDMO is yet to come. Dr.Signal combines AI in the process, not only to identify cell quality but also to optimize production schedules, improve capacity utilization, and even update the content and identify counterfeit products of cell drug packaging in real-time. It is reported that Dr.Signal can collect tens of thousands of parameters related to cell preparation every day. In the future, it is expected to become an important database for the development of precision personalized medicine by combining personal medical history, insurance, genetics, and other data.

 The outside world generally believes that Taiwan's strength lies in hardware, but software has higher added value. However, Dr. Mi Hsin-Wu believes that for any industry, the development sequence starts with infrastructure. It is a necessary condition for achieving digital transformation and intelligence. Taiwan does not necessarily have to completely abandon this advantage. After enjoying the hardware dividend, it can derive new business models from infrastructure. In addition to nurturing the second new business, the most important thing is to rely on hardware to accumulate the data advantages that other latecomers do not have.

 Dr. Mi Hsin-Wu revealed that Dr.Signal's CDMO business officially entered the profitable stage of commercialization from the laboratory in 2024, and new production lines will also be launched in 2024. The next market layout will focus on overseas markets. Dr.Signal has already established itself in markets such as Singapore, North America, and the Middle East, and further IPO plans are not ruled out.

Dr.Signal recently went to the Digital Medical Expo in Berlin (DMEA) to seize the European market. It is understood that Dr.Signal is a key exhibitor from Taiwan at the exhibition, and many heavyweight medical companies, including Johnson & Johnson, Roche, Siemens, Google, HPE, and Microsoft, competed at the same event.

 Dr. Mi Hsin-Wu stated that digitalization of European healthcare is at a turning point. Besides facing a sensitive moment of decentralization, the pace of digital transformation in the biomedical industry is slightly slow. So far, it still focuses more on the digitization of operational processes. Dr.Signal emphasizes starting with infrastructure, which coincides with Europe's strategy of implementing digital transformation steadily. Therefore, it has received considerable attention locally.

Source: Digi Times