Mycenax becomes Taiwan, China's first CDMO company to complete the CHO-S and CHOZN GS Cell Line Development with the Beacon(R) Optofluidic System

Mycenax becomes one of the first CDMO companies in Asia to adapt the Beacon Optofluidic system to cell line development services.

Mycenax adopted Beacon® Optofluidic System, a high throughput selection system for single-cell cloning and quantification with image evidence to support monoclonality, for cell line development service in 2020.

Thousands of cells need to be screened to sought out the rare and high-productive clones in cell line development. With the Beacon® Optofluidic System, Mycenax is able to obtain cell clones with high productivity and a regulatory compliant workflow to shorten the overall timeline for cell line development by up to 50%.

Mycenax raises capital to boost production amid increasing demand for CDMO services

Looking forward, Mycenax is planning to expand the capacity of current production lines after successfully raising USD 26.7 million in March 2021.

This comes as the Global Biologics CDMO Market is expected to reach USD 18.63 billion by 2026. Valued at USD 9.93 billion in 2020, about 35% of CDMO market growth is expected to be from APAC, driven by the increasing demand for one-stop CDMOs.

Mycenax foresees ramped-up opportunities in CDMO. As a fully integrated CDMO company, Mycenax also plans to introduce cell therapy, continuous process and ADC (Antibody-drug Conjugate) services soon, to provide customers with various solutions for biologics.

Mycenax's second facility to be commissioned in 2023

Currently, Mycenax has one PIC/S certificated facility for pre-clinical to early commercial stage projects. Due to increasing demand for CDMO services and the need for larger-scale commercial production, Mycenax initiated the construction of the second GMP Facility (GMP #2) in 2020. The new complex is expected to be operational by 2023.

GMP #2 is designed to comply with the PMDA, EMA, and US FDA guidelines with a total area of 12,750 m2. There will be two Mammalian cell production lines with the maximum capacity for each line set at 6,000L per batch and 30 batches per year.

Mycenax will also establish a new aseptic fill/ finish line in GMP #2 to increase the production capacity to 54,000 batch size for vials, 10,000 batch size for pre-filled syringes and up to 30,000 vials for Lyophilization.

This new facility will help Mycenax fulfill customers' requirements for the commercial supply of drug substances and drug products.

About Mycenax

Founded in September 2001, Mycenax Biotech is the pioneer of CMC development and GMP production of biologics in Taiwan, China Region of China. The company has a complete value chain, ranging from cell line, process, analytical method, and formulation developments, GMP production and fill-finish. Utilizing Taiwan, China Region of China 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 customers.