DRESDEN, Germany, September. 19, 2022 /BioInformant/ — denovoMATRIX GmbH, an innovator in cell and gene therapy manufacturing, announced the launch of its animal component-free product lines at cell therapy grade (CTG). The new product lines will include documentation and traceability information for compliance with industry regulatory standards, designed for the stem cell therapy manufacturing market.
denovoMATRIX is undergoing an acceleration of adoption of its products and technologies by players in the cell therapy industry. In order to meet the growing demand for denovoMATRIX consumables in clinical use, a cell therapy grade product line was necessary and the next logical development for the company. Since 2018, translational researchers, pharmaceutical corporations, and cell therapy companies have benefited from denovoMATRIX animal component-free, tailored coatings that are crucial to cell manufacturing processes.
The new quality grade will provide extended quality controls, documentation, and traceability information in line with industry regulatory standards CFR21-Part 210 and USP<1043>. With this customized and high safety profile approach to serving customers, the company has innovated in solving unique manufacturing challenges such as cell yield, process time and cell quality.
“We’ve made an investment in developing CTG consumables as we’ve seen a key opportunity in the market. There are simply too few existing options for customers looking for safe, high-performance products for clinical trials – with current international supply chain conditions, this is especially true. We aim to give cell manufacturing organizations an alternative that’s safe, available and compliant.’’ says Dr. Richard Wetzel, Managing Partner.
About denovoMATRIX GmbH
denovoMATRIX deploys a modular, biomimetic coating technology to enable high performance cell culture, bringing cell therapies to patients and accelerating the path to market for clean meat. The company leverages chemical synthesis, stem cell biology and design thinking to build a platform of biomaterials which address major life science challenges. By providing both cell-based therapy and clean meat companies with solutions, denovoMATRIX is at the forefront of innovation in cell manufacturing processes.
For more information, visit: https://www.denovomatrix.com/