Mycenax Biotech announced the official opening of its GMP manufacturing plant, GMP Plant 2, in Miaoli on January 14th, 2022.
The global demand for CDMO services is skyrocketing due to capacity shortage caused by COVID-19 pandemic. In 2019, Mycenax became a fully integrated CDMO company and aimed to provide CDMO services for biologics development with international standard to the clients around the world. The opening of GMP Plant 2 will augment mammalian cell and fill/finish capacity of Mycenax.
The GMP Plant 2 is a 6-story building with a total area of 12,750 m2. It includes two mammalian cell production lines, each with a maximum capacity of 6,000L. It is also equipped with an aseptic filling line for liquid and lyophilized dosage forms. The maximum production capacity for the fill/finish line can reach up to 120 batches per year. With this expansion, Mycenax will become one of the leading providers for mammalian cell culture in Taiwan.
The facility is designed to comply with PMDA/EMA/US FDA guidelines. This state-of-the-art manufacturing facility will support the productions for phase III trials and commercial supply.
In addition, Mycenax unveiled its plan to build GMP Plant 3 for ADC (Antibody-drug- conjugates) and a allogeneic cell therapy to meet the industry trend. The GMP Plant 3 will enable Mycenax to offer innovative technologies for the manufacturing new biologic therapeutics.
About Mycenax
Founded in September 2001, Mycenax Biotech is the pioneer of CMC development and GMP production of biologics in Taiwan. The company has a complete value chain, ranging from cell line, process, analytical method, and formulation developments, GMP production and fill/finish. Utilizing Taiwan as the center for development and manufacturing, Mycenax integrates the up- and downstream of the industry to offer contract development and manufacturing services to worldwide clients.
Mycenax Biotech announced the official opening of its GMP manufacturing plant, GMP Plant 2, in Miaoli on January 14th, 2022.
The global demand for CDMO services is skyrocketing due to capacity shortage caused by COVID-19 pandemic. In 2019, Mycenax became a fully integrated CDMO company and aimed to provide CDMO services for biologics development with international standard to the clients around the world. The opening of GMP Plant 2 will augment mammalian cell and fill/finish capacity of Mycenax.
The GMP Plant 2 is a 6-story building with a total area of 12,750 m2. It includes two mammalian cell production lines, each with a maximum capacity of 6,000L. It is also equipped with an aseptic filling line for liquid and lyophilized dosage forms. The maximum production capacity for the fill/finish line can reach up to 120 batches per year. With this expansion, Mycenax will become one of the leading providers for mammalian cell culture in Taiwan.
The facility is designed to comply with PMDA/EMA/US FDA guidelines. This state-of-the-art manufacturing facility will support the productions for phase III trials and commercial supply.
In addition, Mycenax unveiled its plan to build GMP Plant 3 for ADC (Antibody-drug- conjugates) and a allogeneic cell therapy to meet the industry trend. The GMP Plant 3 will enable Mycenax to offer innovative technologies for the manufacturing new biologic therapeutics.
About Mycenax
Founded in September 2001, Mycenax Biotech is the pioneer of CMC development and GMP production of biologics in Taiwan. The company has a complete value chain, ranging from cell line, process, analytical method, and formulation developments, GMP production and fill/finish. Utilizing Taiwan as the center for development and manufacturing, Mycenax integrates the up- and downstream of the industry to offer contract development and manufacturing services to worldwide clients.