Biopharma and Life Sciences
Mycenax Jhunan factory II project - building biotech excellence in Taiwan
Biopharma and Life Sciences
Mycenax Jhunan factory II project - building biotech excellence in Taiwan
Mycenax Biotech is a CDMO specializing in end-to-end development and manufacturing of biotherapeutics, including antibodies, ADCs, and cell and gene therapies.
Location: Jhunan, Taiwan
Industry: Biopharmaceuticals
Business Unit: Biopharma and Life Sciences
Scope: Full EPC fit-out for a good manufacturing practice (GMP)-compliant biopharma facility, including production cleanrooms, warehouse, labs, office, and Central Utility Building (CUB)
Project scale: A brownfield with a land area of 3,186 m2
Contract manufacturing services and biosimilar in protein drug production approval by TFDA, EMEA, U.S / FDA, Japan / PMDA, and PIC/S GMP.
Execution model: Engineering, Procurement, and Construction (EPC)
Timeline: 2019 - 2022
Total Gross Floor Area (GFA): 13,100 m2
Total Recordable Incident Rate (TRIR): 0 (3 years without any recordable incidents)
Total safety hours: 350,341 from (2020-2022)
Background
Mycenax Biotech is a dedicated Contract Development and Manufacturing Organization (CDMO) for biotherapeutics, including established and emerging modalities such as antibodies, antibody drug conjugates (ADCs), and cell and gene therapies (CGT). Mycenax began operation in 2001 and provides services covering full development workflows, including drugability studies, cell line development (CLD), process development, manufacturing, and filling.
As an ambitious and high-achieving enterprise, Mycenax sought to expand its operations to help resolve the production capacity shortage caused by the COVID-19 pandemic. To achieve this, they aimed to construct a second GMP-compliant facility dedicated to producing both drug substance and drug product for traditional biologics, using mammalian cell culture systems.
The challenge
This ambitious project demanded a full EPC transformation of an existing structure, replacing a four-level building with a modern six-floor plant. Extending the brownfield site posed distinct technical and regulatory challenges, particularly the need to support modern biologics production, which demands flexible layouts and adaptable infrastructure.
This project involved working with unknown or outdated building and soil conditions, which required careful consideration to ensure safety and lasting structural integrity. Central to this was the integration of the new plant with existing buried infrastructure, such as plumbing, which needed to conform to regulatory and industry standards and meet production demands. The dismantling of an existing structure also required careful planning to maintain structural stability with minimal disruption to the infrastructure that would become part of the final building. Logistical considerations, such as the reallocation of elevators, were crucial from an early stage.
Designing a good laboratory practice (GLP)-compliant facility with drug substance manufacturing areas, production cleanrooms, fill/finish areas, warehouse capabilities, process design and quality control labs, offices, CUB, and car parking required careful planning. The final layout needed to minimize contamination risk between production lines while ensuring staff safety and enabling the exchange of infrastructure between different areas as required. This needed to be achieved while adhering to PMDA, EMA, and US FDA requirements. Each consideration needed to be integrated from the beginning, as shortcomings could risk regulatory non-compliance and costly development delays.
Finally, the facility needed to be built to meet the competitive demands of the expanding biologics market and position Mycenax Biotech as a reliable partner of choice for CDMO solutions for current and future therapies.
The solution
Exyte provided an expert-led service from the earliest stages of this project, performing feasibility and sustainability studies and ensuring a complete understanding of Mycenax’s requirements before the planning process.
Exyte managed and executed the complete EPC transformation of the existing structure, incorporating two production lines equipped with a total of six single-use 2,000 L bioreactors for monoclonal antibody production, along with a fill/finish area capable of processing 120 batches per year in both liquid and lyophilized dosage forms. Multi-product plants are quickly becoming the norm in the biopharmaceutical industry as the market shifts away from a “blockbuster” model and towards smaller-scale personalized production approaches.
Exyte’s industry expertise and knowledge ensured that modern capabilities were built into the foundation of the new GMP plant, providing Mycenax with the flexibility to adjust its production output to market trends.
Results
Construction began in August 2020 with the complete dismantling of the existing building to its bare structure and the construction of the new six-story facility. The new plant was operational by January 2022, marking an impressive construction turnaround of just 18 months. The new plant aligns with Taiwan FDA, US FDA cGMP, EC EMA, and Japan PMDA guidelines on GMP and supports phase III trial and commercial production of biologics produced via mammalian systems. The new plant comprises 13,100 m2 of floor area, and zero recordable incidents were reported across more than 350,000 total safety hours during construction, marking a significant achievement in construction safety and execution. The project was delivered to the highest standards, on schedule, and within budget.
“I am very pleased with Exyte’s performance on schedule and budget management. We look forward to growing our business by using this new facility.”
– Pei-Jiun Chen, President of Mycenax
Recognition and outlook
In acknowledgement of the outstanding achievement of delivering a full EPC transformation of the Jhunan plant to the highest standards, Mycenax Biotech awarded Exyte its “2022 Excellent Award.”
“The team’s expertise, attention to detail, and deep understanding of GMP manufacturing helped us achieve this important milestone.”
– Mark Fu, Project Manager, Mycenax Jhunan Project
The success of this project provides a solid foundation for future collaboration between Exyte and Mycenax, as the latter gains greater recognition as a major supplier of mammalian cell culture capabilities across Taiwan and Asia.
Exyte is very proud to have played a role in this important milestone, delivering a facility that reflects the future of biopharmaceutical manufacturing in Asia and beyond.
