Magicell® is the registered trademark of Medigen Biotechnology Corp. for its proprietary cell therapy technologies and products.  The "NK" in Magicell®-NK refers to "natural killer" cells.  Magicell®-NK represents Medigen's unique technology platform for activating and producing NK cells.

The Magicell®-NK platform enables the cultivation of NK cells with high purity (≥95%), strong cytotoxicity (≥70% at an E:T ratio of 1), and high cell yield (5~50 x 10⁸ cells per 1,000 ml).  The resulting product complies with the standards of Taiwan's Ministry of Health and Welfare under the "Regulations Governing the Application of Specific Medical Examination Techniques and Medical Devices."  Between 2020 and 2024, Magicell®-NK was approved for use in 10 hospitals across Taiwan to treat cancer patients.

Magicell®-NK has received approvals from the Taiwan Food and Drug Administration (TFDA) to conduct two clinical trials: (1). A Phase I clinical trial using autologous NK cells as an adjuvant therapy for patients with colorectal cancer after surgery; and (2). A Phase I/II clinical trial using allogeneic NK cells in combination with chemotherapy as an adjuvant therapy for patients with pancreatic ductal adenocarcinoma (PDA) or cholangiocarcinoma after surgery.

Through these clinical studies, Medigen aims to expand the therapeutic application of Magicell®-NK to benefit more patients. The company is actively seeking to advance commercialization through strategic partnerships and alliances.
 

 

"ACE™" (Automated Cell Expansion) system is an automated cell expansion device developed by Medigen Biotechnology Corp., designed to expand various types of suspension immune cells.  With its all-in-one design that integrates cell expansion, automated media infusion, media storage, and process monitoring, ACE addresses key challenges in cell therapy manufacturing — such as labor-intensive procedures, contamination risks, limited process monitoring, and the need for highly skilled personnel.  ACE incorporates Medigen's proprietary patented technology, "TrackClamp", featuring a compact design that saves space, seamlessly integrates with standard consumables, and significantly simplifies operational procedures.  It also overcomes the limitations of traditional “wave-based” cell culture technologies.  With its compact, integrated, and highly compatible design, ACE is well-suited for large-scale CDMO production lines as well as laboratories and clinical settings focused on personalized medicine.  The system has been validated for the cultivation of NK, GDT, and CIK cells. Even when using publicly available culture protocols, ACE consistently produces cells of higher quality and yield compared to manual operations.  ACE is ISO 13485:2016 certified and has been filed for patents in multiple countries.  We look forward to advancing the commercialization of ACE through strategic partnerships and licensing collaborations.

 

PI-88 is a mixture of highly sulfated monophosphorylated mannose oligosaccharides derived from the sulfation of hydrolysed phosphomannan produced by the yeast.  Preclinical studies have demonstrated its dual mechanisms: anti-angiogenesis and anti-metastasis.  Medigen has successfully conducted Phase I, Phase II, and a global Phase III clinical trials of PI-88 in patients with HCC in Asia including Taiwan, Korea, China and Hong Kong.  Medigen has established a comprehensive patent portfolio for PI-88, with protection extending to 2032.  The intellectual property rights for PI-88 outside of Taiwan have been licensed to a biotechnology company in mainland China for further development and commercialization.

Human Leukocyte Antigen (HLA) diagnostics are widely used in organ transplantation, transfusion safety, autoimmune diseases, drug hypersensitivity, and other clinical applications.  In 2006, Medigen acquired core HLA typing technology by purchasing U.S.-based Texas BioGen, Inc., and established a diagnostics division to develop and register HLA products in both Taiwan and the U.S.  The company obtained TFDA registration, ISO 13485 certification, CE marking, and U.S. FDA approval.  It also set up the first ASHI-certified HLA typing laboratory in Taiwan.  To focus on this business, Medigen later spun off the division into TBG Biotechnology Corp., a subsidiary dedicated to nucleic acid-based diagnostics.

 

With a vision to establish Taiwan's independent vaccine manufacturing capability, Medigen launched its vaccine business in 2008 by establishing a dedicated vaccine division to develop a cell-based vaccine production platform.  In 2009, Medigen partnered with Taiwan's National Health Research Institutes (NHRI) to co-develop cell-based vaccine technologies and obtained a license for NHRI's H1N1 influenza vaccine technology.  Building on this collaboration, Medigen enhanced the technology and conducted clinical trials, completing preclinical safety studies and process development for both H1N1 and H5N1 vaccines.  The company also completed a Phase I clinical trial for the H5N1 vaccine and filed patents to protect its intellectual property.  In 2012, Medigen spun off its vaccine division to form Medigen Vaccine Biologics Corp. (MVC), which now operates independently as a subsidiary focused on the development, manufacturing, and commercialization of vaccines and biologics.

 

ccPCR (Convective & Circular PCR) is an innovative isothermal technology developed by Medigen that enables efficient polymerase chain reactions using a single, constant-temperature heat source.  Unlike conventional PCR, which requires multiple temperature cycles — resulting in high power consumption and bulky equipment — ccPCR is compact, energy-efficient, and well-suited for Point-of-Care Testing (POCT) and on-site testing applications.  Medigen began developing the ccPCR platform in 2007 through collaboration with the College of Medicine and College of Engineering at National Taiwan University.  The company later partnered with the Industrial Technology Research Institute (ITRI) to further develop specialized reagents and devices.  Today, ccPCR is protected by a global patent portfolio and has been successfully out-licensed to biotechnology companies.