Cold Spring Biotech Corp. is vigorously promoting automated exosome production technology, establishing it as a new focus in regenerative medicine. Since the revision of the Special Regulation Act on February 9, 2021, exosome technology has increasingly replaced stem cells as a significant research direction in regenerative medicine.

In recent years, exosomes have created a buzz in the global biotech market, with Taiwan joining the trend. The Ministry of Health and Welfare has officially approved the use of exosomes derived from human cells as cosmetic ingredients, making Taiwan the fifth country globally to allow human-derived exosomes in the medical beauty market. Our company is also a founding member of the Exosome Association.

Moreover, the Ministry of Health and Welfare's Center for Drug Evaluation (CDE) drafted guidelines for the manufacture and control of exosomes in February. These guidelines aim to help biotech companies further explore the vast commercial opportunities in the global new drug and vaccine markets. This initiative is regarded as a significant milestone in the biotech industry.

A report from the Biotech Center indicates that exosomes are special active vesicles secreted by cells during the cultivation process. They can regulate cellular inflammatory responses and promote the regeneration of damaged cells, showing significant efficacy in disease treatment. According to the latest draft amendment of the "Regenerative Medicine Development Act" by the Ministry of Health and Welfare, exosomes have been included in the category of emerging biotherapies.

However, the core challenge of exosome technology lies in achieving standardization and scalable production to ensure product quality and safety. The EXODUS T-2800 system was recently unveiled. This fully automated exosome extraction system uses ultrasonic nano-filtration (EXODUS) technology, automating the entire process from sample pre-treatment to concentrated collection. It is widely applicable in exosome drug delivery, therapy, and regenerative medicine, and complies with GMP standards.

Additionally, Cold Spring Biotech Corp. has introduced NanoFCM technology (Nano-Flow Cytometry) to efficiently detect the multi-parameter characteristics of biological nanoparticles, providing robust support for the standardization and quality control of exosomes. NanoFCM can directly detect individual exosome particles and accurately analyze their structural components, aiding in the standardization and safety of exosome samples.

Cold Spring Biotech Corp. is dedicated to using exosome technology to address challenges faced by stem cell therapies, advancing the field of regenerative medicine, providing more innovative opportunities for the global medical community, and bringing greater growth prospects for the company.