Matica Biotechnology opens manufacturing facility in Texas
The biotechnology company held a ribbon-cutting ceremony at the plant, with CEO Song Yun-jeong and College Station Mayor Karl Mooney attending.
The contract and development manufacturing organization (CDMO) plant is equipped with a 500-liter bioreactor and is designed to meet the Current Good Manufacturing Practice regulations, which are enforced by the U.S. Food and Drug Administration (FDA).
It is also installed with a modular Portable On Demand system, which offers the flexibility to adjust resources required depending on client need and product requirements, the company said.
In the facility, the biotechnology company will produce viral vectors that are core materials for the development of cell and gene therapies. For this, Matica has been working with Göttingen, Germany-based Sartorius to develop advanced technologies for large-scale viral vector production. Sartorius offers Matica its single-use bioreactors that can be used in biopharmaceutical manufacturing processes and using the bioreactors, Matica develops process analytical technology (PAT) and automation software needed for mass manufacturing viral vector products.
PAT, according to FDA, refers to a system for designing, analyzing and controlling pharmaceutical manufacturing processes through the measurements of critical quality and performance attributes of raw and processed materials to ensure the quality of the final product.
“Compared to small molecule or protein-based products, cell and gene therapy is the next generation medicine that requires application of innovative technology.” said Matica Biotechnology CEO Song Yun-jeong. "By applying the 20 years of cell therapy research history by CHA Biotech, Matica Bio’s goal is to become industry’s leading CDMO specializing in cell and gene therapies.”
CHA Biotech is building a 10-story cell and gene therapy manufacturing plant in Pangyo, Gyeonggi, with the goal of finishing the construction by the end of 2024. The company is investing $250 million in the factory.
The size of the global cell and gene therapy CDMO market, which was valued $1.5 billion in 2019, is expected to grow at an annual rate of 31 percent and reach $10.1 billion in 2026, according to data provided by market research firm Frost & Sullivan.
BY SARAH CHEA [email@example.com]