[Taipei, June 1, 2023] Mycenax Biotech (TWO: 4726), a Taiwanese contract development and manufacturing organization (CDMO) specializing in innovative development ability (D) combining adequate manufacturing capacity (M), announced today the groundbreaking of its cell therapy pilot plant. The plant will be located in the second biotech building of Hsinchu Biomedical Science Park. Considering the current market demands and development timelines for the production capacity of cell therapy products, the first phase will involve constructing a 50-liter scale allogeneic cell therapy PIC/S GMP plant adopting the pilot plant model. Completion is expected in 2024, aiming to provide one-stop development and production services for allogeneic cell therapy products.
Mycenax Biotech stated, "Both domestic and international biotech companies are rapidly entering the field of developing novel cell therapy and production technologies. Mycenax's development strategy places particular emphasis on the key technology of “closed and scalable manufacturing process” that is critically needed for allogeneic cell therapy development. We have successfully developed and scaled up allogeneic cell therapy processes in collaboration with our clients, enabling the increased production scale of allogeneic immune cells to that of 200 liters under GMP conditions, and assisted clients in obtaining Phase I clinical trial approvals in the United States. Since 2021, Mycenax Biotech has established a focal cell therapy development team and laboratory, and we have already established advanced large-scale 3D production processes for mesenchymal stem cells (MSCs), surpassing the international industry standard of 15 billion cells in a 50-liter bioreactor. Furthermore, advanced process and analysis technologies for allogeneic cell therapies are still in development, such as chimeric antigen receptor-natural killer cells (CAR-NK), Gamma Delta-T (GDT), and mesenchymal stem cell-derived extracellular vesicles (MSC-EVs)."
The cell therapy pilot plant located in the Hsinchu Biomedical Science Park will adopt an automated, closed, and modular cell therapy production process line. It will provide one-stop customized process design, development, and production services based on the diverse and complex nature of cell therapy products required by clients. The plant will also incorporate Mycenax Biotech's advantageous 3D expansion process technology to address the roadblocks of large-scale cell production for allogeneic cell therapy clinical trials, keeping the goal of accelerating the commercial development of cell therapy novel drugs for clients.
About Mycenax
Mycenax takes the CDMO brand positioning of "big D in medium M" with "Innovative development abilities (D) and Adequate manufacturing capacity (M)" to provides one-stop services for the development and manufacture of traditional biologics and novel biological drugs. At its core, Mycenax is committed to the development and production of biological drugs, from the R&D phase to cGMP manufacturing plants to drug commercialization. Mycenax, as an international CDMO company, continuously invests in product development innovations and technology platform optimizations in order to provide customers with comprehensive and streamlined CDMO services. Mycenax Biotech currently has a capital of 2.05 billion NTD (~67.2 million USD).
Stock code: Mycenax Biotech (4726).
Company website: http://www.mycenax.com.tw
Press Contact:
Stacy Sun
Email: stacy.sun@mycenax.com.tw
[Taipei, June 1, 2023] Mycenax Biotech (TWO: 4726), a Taiwanese contract development and manufacturing organization (CDMO) specializing in innovative development ability (D) combining adequate manufacturing capacity (M), announced today the groundbreaking of its cell therapy pilot plant. The plant will be located in the second biotech building of Hsinchu Biomedical Science Park. Considering the current market demands and development timelines for the production capacity of cell therapy products, the first phase will involve constructing a 50-liter scale allogeneic cell therapy PIC/S GMP plant adopting the pilot plant model. Completion is expected in 2024, aiming to provide one-stop development and production services for allogeneic cell therapy products.
Mycenax Biotech stated, "Both domestic and international biotech companies are rapidly entering the field of developing novel cell therapy and production technologies. Mycenax's development strategy places particular emphasis on the key technology of “closed and scalable manufacturing process” that is critically needed for allogeneic cell therapy development. We have successfully developed and scaled up allogeneic cell therapy processes in collaboration with our clients, enabling the increased production scale of allogeneic immune cells to that of 200 liters under GMP conditions, and assisted clients in obtaining Phase I clinical trial approvals in the United States. Since 2021, Mycenax Biotech has established a focal cell therapy development team and laboratory, and we have already established advanced large-scale 3D production processes for mesenchymal stem cells (MSCs), surpassing the international industry standard of 15 billion cells in a 50-liter bioreactor. Furthermore, advanced process and analysis technologies for allogeneic cell therapies are still in development, such as chimeric antigen receptor-natural killer cells (CAR-NK), Gamma Delta-T (GDT), and mesenchymal stem cell-derived extracellular vesicles (MSC-EVs)."
The cell therapy pilot plant located in the Hsinchu Biomedical Science Park will adopt an automated, closed, and modular cell therapy production process line. It will provide one-stop customized process design, development, and production services based on the diverse and complex nature of cell therapy products required by clients. The plant will also incorporate Mycenax Biotech's advantageous 3D expansion process technology to address the roadblocks of large-scale cell production for allogeneic cell therapy clinical trials, keeping the goal of accelerating the commercial development of cell therapy novel drugs for clients.
About Mycenax
Mycenax takes the CDMO brand positioning of "big D in medium M" with "Innovative development abilities (D) and Adequate manufacturing capacity (M)" to provides one-stop services for the development and manufacture of traditional biologics and novel biological drugs. At its core, Mycenax is committed to the development and production of biological drugs, from the R&D phase to cGMP manufacturing plants to drug commercialization. Mycenax, as an international CDMO company, continuously invests in product development innovations and technology platform optimizations in order to provide customers with comprehensive and streamlined CDMO services. Mycenax Biotech currently has a capital of 2.05 billion NTD (~67.2 million USD).
Stock code: Mycenax Biotech (4726).
Company website: http://www.mycenax.com.tw
Press Contact:
Stacy Sun
Email: stacy.sun@mycenax.com.tw