 |
| Matica Bio CEO Song Yun-jeong, fifth from left, and officials of the firm and other dignitaries in the public and private sectors participate in a tape-cutting ceremony at the opening of the U.S. affiliate of CHA Biotech, May 3 (local time). Courtesy of CHA Biotech |
By Lee Kyung-min
Matica Biotechnology, a U.S. affiliate of CHA Biotech, has opened a cell and gene therapy manufacturing facility in College Station, Texas, according to the cell therapeutics and stem cell developer affiliate of CHA Medical & Bio Group, Wednesday.
The contract development and manufacturing organization (CDMO) facility met the Current Good Manufacturing Practice (cGMP) required to conform to related guidelines recommended by pharmaceutical authorization agencies including the U.S. Food and Drug Administration (FDA).
Best-in-class experts in cell and gene therapy manufacturing will advance CHA Biotech's business by utilizing their experience and expertise in the management of over 250 vector production projects for over 10 types of viral vectors at global leading CDMO players. They are Lonza, a Swiss multinational pharmaceutical manufacturer, Fujifilm Dyosynth, a Massachusetts-headquartered multinational pharmaceutical, and Charles River, an American pharmaceutical firm. The high-tech global standard facility has a 500-liter bioreactor.
Vectors are essentially vehicles designed to deliver therapeutic genetic material, such as a working gene, directly into a cell.
Matica Bio also installed a modular portable on-demand (POD) system, a specialty of G-CON Manufacturing, a U.S. cleanroom designer and solution provider for the pharmaceutical and biopharmaceutical industries. The POD system adjusts resources on client needs and product requirements.
It will produce viral vectors including lentivirus vectors and adeno-associated virus vectors.
A joint project is ongoing with Sartorius, an international pharmaceutical and laboratory equipment supplier, to develop and optimize advanced viral vector manufacturing technologies for large-scale vector production.
Similar joint research is in progress between Matica Bio and Texas A&M University's Center for Innovation in Advanced Development and Manufacturing for plasmid DNA and protein studies to speed up biotech research and development and commercial manufacturing.
"Compared to small molecule- or protein-based products, cell and gene therapy is the next-generation medicine that requires the application of innovative technology," Matica Bio CEO Song Yun-jeong said.
"Matica Bio with the 20 years of cell therapy research work of CHA Biotech will become the industry's leading CDMO specializing in cell and gene therapies."
