Following the completion of its GMP plant, Mycenax Biotech has granted Exyte its "2022 Excellent Award”. With this award, the biotech company recognises Exyte's excellence in engineering, procurement, construction (EPC) and delivery of Mycenax’s GMP plant project in Jhunan, Taiwan.
Mycenax announced the official opening of its GMP manufacturing plant, GMP Plant 2, in January 2022 after the global demand for CDMO services skyrocketed due to capacity shortage caused by COVID-19 pandemic.
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In 2019, Mycenax had become a fully integrated CDMO company and aimed to provide CDMO services for biologics development with international standards to clients around the world. The opening of GMP Plant 2 augmented mammalian cell and fill/finish capacity of Mycenax.
The specs
The GMP Plant 2 is a 6-story building with a total area of 12,750 sqm. It includes two mammalian cell production lines, each with a maximum capacity of 6,000 L. It is also equipped with an aseptic filling line for liquid and lyophilised 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.
